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The Ministry of Foreign Trade and Economic Cooperation, the China Export Credit Insurance Corporation
Circular of the Ministry of Foreign Trade and Economic Cooperation and China Export Credit Insurance Corporation on Issues Concerning
Further Promoting Export Credit Insurance
WaiJingMaoJiCaiHan [2002] No.521
October 29, 2002
The departments (commissions, bureaus) of foreign trade and economic cooperation of all provinces, autonomous regions, municipalities
directly under the Central Government and municipalities separately listed on the State plan, the chambers of commerce of import
and export, and the business management departments of China Export Credit Insurance Corporation:
As a general international practice, export credit insurance is a policy measure adopted by the countries to promote their product
export, the purpose is to encourage the enterprises to increase export by the state’s bearing of the risks in the collection of foreign
exchange in foreign trade. The practices of the countries have proved that by purchasing export credit insurance, export enterprises
may avoid risks in the export collection of foreign exchange, guarantee the safe export collection of foreign exchange and expand
the enterprises’ export scale.
Since its foundation at the end of 2001, China Export Credit Insurance Corporation has actively built its enterprise structures, set
forth its internal rules and regulations, sorted out various kinds of external relations, and meanwhile, done a great deal of work
in improving the export credit insurance products, bettering the services for export enterprises and lowering the premium rate of
export credit insurance etc. This will actively promote the foreign trade and economic strategies of China of “vitalizing trade by
science and technology”, “a multi-outlet market” and “going global” etc. In order to publicize and spread the policy of export credit
insurance in a wider range, to promote the enterprises to understand and use export credit insurance to increase their exports, and
to further improve the export credit insurance mechanism of China, the relevant issues are notified as follows:
I.
Establishing a steady and expedite contact mechanism.
The departments of foreign trade and economic cooperation at various levels, the chambers of commerce of importers and exporters and
China Export Credit Insurance Corporation as well as its branches shall contact each other and strengthen the coordination and communication.
The departments of foreign trade and economic cooperation at various levels, and the chambers of commerce of importers and exporters
shall, in light of the actual development of the foreign trade and economic cooperation of their respective regions and the business
of their respective lines, understand the need for export credit insurance of the export enterprises within the regions and industries
under their respective jurisdiction, and make the need known to the credit insurance institutions in a timely manner. The branches
of export credit insurance shall voluntarily provide various kinds of business information and materials to the departments of foreign
trade and economic cooperation and the chambers of commerce of importers and exporters of the places where they are located, and
shall inform the departments and chambers of their business process.
II.
Publicizing and spreading export credit insurance in an all-around and thorough way.
The departments of foreign trade and economic cooperation at various levels, and the branches of China Export Credit Insurance Corporation
shall strengthen their cooperation, and carry out various kinds of publicizing and introducing activities in light of the actual
situations of the localities, so that the export enterprises can fully understand and utilize the policy of export credit insurance
in good time.
III.
Summing up the experiences in export credit insurance work, and promoting the development of export credit insurance.
The localities shall carry out a thorough investigation and research in light of the situations of their respective regions, find
out and settle the problems existing in export credit insurance work in a timely manner; shall actively seek vigorous support from
the local governments, and promote the business of export credit insurance and the development of foreign trade and economic undertakings
of their respective regions by learning the beneficial experiences of other provinces and cities.
The entities shall earnestly implement the spirit of this Notice, if any problem is encountered in the implementation, please report
to the Ministry of Foreign Trade and Economic Cooperation (Department of Project Funding) and China Export Credit Insurance Corporation
(Department of Business Development).
This is hereby the notification.
Attachment:Contact Form of Business Management Departments of China Export Credit Insurance Corporationhtm/e03105.htm New Page 1
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No.
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Name
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Address
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Telephone
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Fax
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Email
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Post Code
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Areas
|
|
1
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Head Office
Zhu Jingan
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Rongjin Mansion, No.5 Fuchengmen North Street, Xicheng District, Beijing
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010-88389121
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010-88386997
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zhuja@sinosure.com.cn
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100037
|
Beijing
|
|
2
|
Da Lian
Liu Yanxiang
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Suits 4706, 4707, 4708, Dalian World Trade Center, No.25, Tongxing Street, Zhongshan District, Dalian City
|
0411-2530529
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0411-2530528
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lyx@sinosure.com.cn
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116001
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Liaoning, Heilongjiang, Jilin, Inner-mongolia
|
|
3
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Tianjin
Bai Lixin
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Tianxin Building,No.125Weidi Road, Hexi District, Tianjin
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022-28408672
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022-28408674
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bailx@sinosure.com.cn
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300074
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Tianjin, Hebei, Shanxi
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4
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Qing dao
Wang Aihua
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Floor 21, No.66 Xianggangzhong Road, Qingdao, Shang dong Province
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0532-5719363
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0532-5719200
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wangah@sinosure.com.cn
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266071
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Shan dong
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5
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Nan jing
Wang Difan
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Floor 12, Huaying International Mansion, Jinluan Alley, Huaihai Road, Nanjing
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025-4467339
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025-4467110
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wangdf@sinosure.com.cn
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210002
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Jiangsu
|
|
6
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Shanghai
Qiu Xinbao
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Floor 12, Jiushi Building, No.28 Zhong shan nan Road, Shang hai
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021-63305986
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021-63305980
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qiuxb@sinosure.com.cn
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200010
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Shanghai, Xinjiang
|
|
7
|
Han zhou
Qian Shuifeng
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Floor 25, Tower B, Biaoli Building, No.528 Yan’an Road, Hang zhou
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0571-85774618
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0571-85774611
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qiansf@siuosure.com.cn
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310006
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Zhejiang Province (excluding Ning bo)
|
|
8
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Ning bo
Chen Xiaoping
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Floor 4, Pufa Mansion, No.21 Jiangxia Street, Ningbo
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0574-87349692
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0574-87348597
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chenxp@sinosure.com.cn
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315010
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Ning bo
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9
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Fu zhou
Cong Jianming
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Suites A1, B, Floor 22, Xintian di Building, No.157 Wusi Road, Fuzhou
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0591-7872518
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0591-7872518
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conejm@sinosure.com.cn
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350003
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Fujian Province (excluding Xia men)
|
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10
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Xiamen
Xu Xinwei
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Apart ment C, Floor 10, International Bank Building, Lujiang Road, Xiamen
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0592-2261806
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0592-2261801
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xuxw@sinosure.com.cn
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361001
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Xiamen
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11
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Guangzhou Chen Liancong
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Suite 23-D, Gaosheng Building, No.109 Tiyuxi Road, Tianhe District, Guangzhou
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020-38792300
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020-38792868
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chenlc@sinosure.com.cn
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510620
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Guangxi, Hainan, Guangdong (excluding Shenzhen)
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|
12
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Shen zhen
Huang Qiang
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Unit G4-01, Diwang Tower, No.5002 Shennan East Road, Shenzhen
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0755-22071518
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0755-25830545
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huangq@sinosure.com.cn
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518015
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Shenzhen
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|
13
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Hunan
Ren Jianhui
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Suite 12-G, Huatianxincheng Great Wall Building, No.259 Furongzhong Road, Changsha
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0731-4897955
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0731-4897855
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renjh@sinosure.com.cn
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410011
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Hunan, Hubei, Guizhou
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|
14
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Jiangxi
Qiu Hongyu
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Room 409, Gloria Plaza Hotel, No.88 Yanjiang North Road, Nanchang
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0791-6738536
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0791-6738710
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qiuhy@sinosure.com.cn
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330009
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Jiangxi
|
|
15
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Anhui
Ma Weixing
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Apartment B, Floor 18, Post & Telecom Building, No.303 Huaihe Road, Hefei, Anhui Province
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0551-2681860
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0551-2581863
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mawx@sinosure.com.cn
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230001
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Anhui Province
|
|
16
|
Shannxi
Zhou Chunzheng
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Room 605, Shengtang International Mansion, No 22 Heping Road, Xi’an
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029-7512123
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029-7512132
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zhoHcz@sinosure.com.cn
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710001
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Shannxi, Qinghai, Gansu, Ningxia
|
|
17
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Sichuan
Doumei
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Room 2913, Sichuan Zhongyin Building, No.35 Section 2, Renminzhong Road, Chengdu
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028-86402786
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028-86402787
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doum@sinosure.com.cn
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610031
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Sichuan Province
|
|
18
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Chongqing
Dai Fang
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No.65 Jianxin North Road, Jiangbei District, Chongqing
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023-69018381
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023-69018291
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dai_f@sinosure.com.cn
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400020
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Chongqing Municipality
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|
19
|
Henan
Yang Yonggang
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Room 2106, Tower A, Henan Guanghui Internat
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The State Economy and Trade Commission
Decree of the State Economy and Trade Commission of the People’s Republic of China
No.39
The Measures for the Administration of Bid Invitation and Tendering for Bid of Fixed Asset Investment Projects of Enterprises in the
Industrial and Commercial Sectors have been adopted at the directors’ executive meeting of the State Economic and Trade Commission
and are hereby promulgated for effect as of December 1, 2002.
Director of the State Economy and Trade Commission Li Rongrong
October 29, 2002
Measures for the Administration of Bid Invitation and Tendering for Bid of Fixed Asset Investment Projects of Enterprises in the Industrial
and Commercial Sectors
Chapter I General Provisions
Article 1
The present Measures have been formulated on the basis of the Law of the People’s Republic of China on Bid Invitation and Tendering
for Bid for the purpose of intensifying the administration of the fixed asset investment projects within the industrial and commercial
sectors, regulating the bid invitation and tendering for bid of fixed asset investment projects in the industrial and commercial
sectors, ensuring the fairness and justice of bid invitation and tendering for bid, protecting the lawful rights and interests of
the parties concerned in bidding activities, increasing economic returns, and ensuring the quality of projects.
Article 2
The present Measures shall be applicable to the bid invitation and tendering for bid of the fixed asset investment projects in the
industrial and commercial sectors within the territory of the People’s Republic of China.
Article 3
The State Economy and Trade Commission (hereafter “the SETC”) and the economy and trade commissions of all provinces, autonomous regions,
municipalities directly under the Central Government, municipality separately listed on the State plan, and the Xinjiang Production
and Construction Corps (hereinafter referred to as “provincial-level economy and trade commissions”) are the administrative departments
in charge of the bid invitation of the fixed asset investment projects within the industrial and commercial sectors (hereafter “the
administrative department of bid invitation”) that are responsible for organizing, guiding and coordinating the bid invitation and
tendering for bid of the fixed asset investment projects within the industrial and commercial sectors.
The SETC shall be responsible for the administration of the bid invitation and tendering for bid of the following projects:
a.
The projects subject to submission by the SETC and approval of the State Council;
b.
The projects subject to the examination and approval of the SETC;
c.
The projects subject to the examination and approval of the provincial-level economy and trade commissions upon the authorization
or entrustment of the SETC;
d.
The projects above a certain limit that have been put in the archivist files of the SETC by the enterprises concerned according to
the relevant provisions;
e.
Other projects as provided by the SETC.
The provincial-level economy and trade commissions are responsible for the administration of the bid invitation and tendering for
bid of the following projects:
a.
The projects subject to the examination and approval of the provincial economy and trade commissions within their respective jurisdictions;
b.
The projects that have been put in the archivist files of the provincial-level economy and trade commissions by the enterprises concerned
according to the relevant provisions;
c.
Any other project whose bid invitation and tendering for bid shall be subject to the supervision and administration of the provincial-level
economy and trade commissions upon the entrustment of the SETC.
Article 4
The purchase of the technologies (including engineering design), equipment (including materials), construction, installation and other
goods and services under the item of the fixed asset investment projects within the industrial and commercial sectors shall be subject
to bid invitation according to the provisions in relevant laws, administrative regulations and the present Measures:
a.
The important investment projects that concern the social public interest or the public security;
b.
The projects totally or partly funded by state-owned funds or state financing;
c.
The projects using the loan or financial aid of international organizations or foreign governments.
The specific scope and standard of scale of the projects as listed in the preceding paragraph shall be the Provisions Concerning the
Scope of Bid Invitation and Standard of Scale of Engineering Construction Projects.
Where there are different provisions concerning the bid invitation of projects, such provisions shall be observed.
Article 5
Any of the projects that meet the requirements provided in Article 4 of the present Measures shall, as a general rule, be subject
to public bid invitation.
In any of the following circumstances, public bid invitation may be held upon the consent of the administrative department of investment:
a.
The project involves any of the intellectual property rights or business secrets of the enterprise that implements the project;
b.
The contents of purchase need to be jointly designed or jointly produced by the project entity and the providers of goods;
c.
The project is general contracting in nature, and thus the technical plans thereof need to be determined by jointly with the providers
of goods;
d.
The security or secret of the state is concerned so that it is inappropriate to hold public bid invitations;
e.
Any other circumstance in which requested bid invitation may be held according to the statutory provisions of the state.
Article 6
For any of the projects as provided in Article 4 of the present Measures, the project entity may, if any of the following circumstances
occurs, make its purchases on its own initiative upon the consent of the administrative department of bid invitation:
a.
It is provided in the project reply that the objects to be purchased concern the protection of intellectual property rights such as
patent, know-how, etc.;
b.
There are fewer than three providers that can provide the subject matter of purchase;
c.
The total investment of the project is less than 30 million yuan, and the estimated contractual value of each purchase of important
equipments or materials is less than 1 million yuan;
d.
The total investment of the project is less than 30 million yuan, and the estimated contractual value of each construction is less
than 2 million yuan.
e.
The total investment of the project is less than 30 million yuan, and the estimated contractual value of each purchase of such services
as prospecting, design, supervision, etc. is less than 500,000 yuan;
f.
It is provided in any of the bilateral agreements concluded between China and any foreign government that it is inappropriate to render
the purchase subject to bid invitation;
g.
It is provided in any of the laws, regulations or policies of the state that it is inappropriate to render the purchase subject to
bid invitation.
Chapter II Bid Invitation and Tendering for Bid
Article 7
After obtaining the project feasibility study report ratified by the administrative department of investment or the archivist filing
documents of the project and the feasibility study report formulated by the investment consultation institutions that have been granted
with corresponding qualifications by the State Economy and Trade Commission (“SETC”), the project entity shall formulated a Checklist
of Purchase for Fixed Asset Investment Projects in the Industrial and Commercial Sectors as enumerated in Attachment I and shall
submit it to the administrative department of bid invitation for archivist purposes.
Article 8
Where the content of a project has undergone important adjustment, the project entity shall, according to relevant provisions, report
to the administrative department of investment, and make revisions to the checklist of purchase on the basis of the ratification
opinions of the administrative department of investment, and at the same time, present the revised checklist of purchase to the administrative
department of bid invitation for archivist purposes.
The phrase “important adjustment” as mentioned in the preceding paragraph refers to that important changes have happened to the content
of the project such as the guiding principles of products, key techniques, technologies of the project, etc. or the scale of adjustment
of the total investment of the fixed asset investment project exceeds 10% of the original budget.
Article 9
The project entities that are capable of formulating bid invitation documents and of organizing bid appraisals may handle the bid
invitations by themselves. the project entities shall, according to relevant provisions, go through the procedures of making archivist
filing for their bid invitations.
Article 10
Project entities may entrust, on their own initiatives, any of the agencies of bid invitation that have been granted with corresponding
qualifications by the SETC (hereafter “bid invitation agencies”) to undertake the bid invitations. No institution that has not obtained
the qualifications of bid invitation agency provided by the SETC may not engage in any of the bid invitation agency for fixed asset
investment projects in the industrial and commercial sectors.
The bid invitation agencies that have obtained the qualifications of bid invitation agency shall engage in the bid invitation agency
business that match with their qualifications according to the relevant provisions.
Article 11
The qualifications of the bid invitation agencies are classified into Grade A, Grade B and Grade B (preparatory).
The bid invitation agencies with the qualification of Grade A may engage in the bid invitation agency of the fixed asset investment
projects of the industrial and commercial sectors both above and below the quotas, and the bid invitation agencies with the qualifications
of Grade B and Grade B (preparatory) may engage in the bid invitation agency of the fixed asset investment projects of the industrial
and commercial sectors below the quotas.
The term “projects above the quotas” as mentioned in the present Article refers to the domestically invested projects with a fixed
asset investment of 30 million yuan or more and the foreign invested projects with a fixed asset investment of 30 million USD or
more. The domestically invested projects above the quotas in the industrial sectors of electric power (including nuclear power),
metallurgy of ferrous metals, chemical industry, construction materials, civil aviation, coal, petroleum chemical industry, petroleum
natural gases, telecommunications (including postal administration), non-ferrous metals (including rare earth), etc. refers to those
whose fixed asset investment is 50 million yuan or more.
Article 12
When entrusting agencies to hold bid invitations, a project entity shall provide the official replies of the projects and a checklist
of purchase for entrusted bid invitation.
When accepting the entrustment of a project entity for bid invitation, a bid invitation agency shall show its certificate of qualifications,
make clear the scope of bid invitation agency business that it engages in, and verify the official replies of the projects and the
contents of the entrusted bid invitation. The parties concerned shall enter into written agreements of entrusted bid invitation.
Article 13
The bid invitation agencies and the project entities that hold bid invitations by themselves shall formulate bid invitation documents
according to the requirements of the projects by referring to the Model Bid Invitation Documents for Fixed Asset Investment Projects
in the Industrial and Commercial Sectors (to be formulated separately), and fill in the Appendixes for Archivist Filing of Bid Invitation
Documents for Fixed Asset Investment Projects in the Industrial and Commercial Sectors as listed in Attachment II. The checklists
of purchase subject to bid invitation, the agreements of entrusted bid invitation, the appendixes for the archivist filing of bid
invitation documents and the bid invitation document shall be presented to the administrative department of bid invitation for archivist
purposes.
Article 14
Bid invitation documents shall be published in designated mass media for no less than 20 days.
Article 15
In case of the bid invitation documents is changed, the bid invitation agency or the project entity that hold bid invitations by itself
shall present the files to the administrative department of bid invitation for archivist purposes and have them published in good
time. The changes shall be informed to all the bid tenderers that have subscribed to the bid invitation documents.
In case the time for opening bids is changed, public announcements shall also be made in corresponding mass media.
Article 16
Bid tenderers shall formulate bidding documents according to the requirements as provided in the bid invitation documents, and submit
the sealed bidding documents and corresponding floppy disks to the bid invitation institution according to the time, venue required
by the bid invitation documents. All bidding documents submitted overdue shall be invalid.
Article 17
Bid tenderers may, prior to the expiration of the prescribed deadline, make supplements or revisions to the bidding documents they
have submitted or even cancel them. The supplements and the revisions shall form a component part of the bidding documents.
Chapter III Bid Opening, Bid Appraisal and Bid Winning
Article 18
Bid invitation agencies and the project entities that hold bid invitations by themselves shall open bids according to the time and
venue as provided in the bid invitation documents. All tenderers shall be invited to participate in the bid opening, and the table
of bid tenderers as well as the bid tendering announcements shall be called out. The records of bid opening and the floppy disks
for bidding documents shall be sealed up on the spot for archivist filing at the administrative department of bid invitation.
Article 19
Where there are fewer than three tenderers for bid, the bid invitation agency or the project entity that holds the bid invitation
by itself may cancel the bid opening, seal up the relevant bidding documents and inform the administrative department of bid invitation
in good time. In the meanwhile, they shall make suggestions to the administrative department of bid invitation with regard to postponing
the bid opening, making a new bid invitation or making the purchase by any other means, carry them out according to the opinions
provided in the official reply of the administrative department of bid invitation.
Article 20
The bid appraisal committee shall consist of five members in odd numbers, among which the experts in the fields of technology and
economics shall not be less than two third of the total members. The constitution of the bid appraisal committee and the selection
of experts shall be made according to the Interim Provisions Concerning Bid Appraisal Committees and Bid Appraisal Methods. The names
of the members of the bid appraisal committees shall be presented by the bid invitation institution before the bid opening to the
administrative department for archivist purposes.
Article 21
The bid appraisal committee shall make appraise bidding documents according to the relevant provisions of the Interim Provisions Concerning
Bid Appraisal Committees and Bid Appraisal Methods, and according to the bid appraisal principles and methods as stipulated in the
bid invitation documents, etc.
Article 22
A bid invitation agencies or project entity that hold bid invitations by itself shall, within 20 days as of the bid appraisal of the
project is finished, formulate a bid appraisal report as listed in Appendix III on the basis of the opinions of the bid appraisal
committee, and present it to the administrative department of bid invitation for archivist purposes. In the meanwhile, it shall make
public announcements in corresponding mass media to disclose the results of bid winning. The term of public announcement is ten days.
Article 23
During the term of public announcement of disclosing the results of bid invitation, if have of the tenderers of bid has objection,
the bid invitation agency or the project entity that hold the bid invitation shall give a reply. However, no information about the
bid appraisal by the bid appraisal committee may be disclosed in the replies. When the term of public announcement expires and no
body lodges any objection, the bid invitation agency or the project entity that holds the bid invitation may issue bid winning notices
to the bid winners, and shall, within five days as of the bid winning notices are sent, present to the administrative department
of bid invitation for archivist purposes.
Article 24
The project entity shall, within 30 days as of the bid winning notices are sent, enter into contracts with the bid winners according
to law.
Article 25
The project entity shall, within 10 days as of the conclusion of contracts, submit a duplicate of the contracts to the administrative
department of bid invitation for archivist purposes.
Chapter IV Supervision of Bid Invitation
Article 26
The bid invitation agencies and the project entities that hold bid invitations by themselves may invite public notaries or the organs
of discipline inspection or government supervision to notarize or supervise the bid invitation activities.
Article 27
Administrative departments of bid invitation shall send supervisors irregularly to supervise bid invitation activities. The supervisors
shall show their Certificates of Authorized Supervision of Fixed Asset Investment Projects in the Industrial and Commercial Sectors
as listed in Appendix IV which are signed by the administrative departments of bid invitation, and shall be enpost_titled to participate
in the major processes of the bid invitation of the designated supervision projects of bid invitation including the opening of bids,
and the appraisal of bids, etc., be enpost_titled to consult the materials of the authorized supervision projects of bid invitation, and
shall submit supervision reports to the administrative departments of bid invitation.
Article 28
Bid invitation agencies shall, as pursuant to the requirements of the administrative department of bid invitation, send appropriate
personnel in good time to serve as the supervisors of the bid invitation projects subject to the authorized supervision of the administrative
departments of bid invitation.
Article 29
Supervisors shall be under the obligation of keeping all contents and information of the bid invitation projects subject to the authorized
supervision of the administrative department of bid invitation secret.
Article 30
Bid invitation agencies shall accept the supervision of the project entities, and shall present to the project entities the Forms
of Feedback from the Clients of Fixed Asset Investment Projects in Industrial and Commercial Sectors as listed in Appendix V, and
present them to the administrative department of bid invitation for archivist purposes after they are filled in and sealed by the
project entities.
Article 31
The administrative departments of bid invitation accepts the complaints that arise in the activities of bid invitation, and make investigations
in collaboration with other relevant departments. If the complaint is undersigned, a written reply shall be given to the undersigned
after verification.
Article 32
The SETC inspects irregularly the work of the bid invitation agencies and the project entities that hold bid invitations by themselves.
Article 33
The SETC makes annual inspections over the qualifications of the bid invitation agencies of the fixed asset investment projects in
the industrial and commercial sectors. The specific rules for the annual inspections of the qualifications shall be separately formulated.
Chapter V Penalty Provisions
Article 34
Where any project entity violates the provisions of Article 4 of the present Measures by evading bid invitations by ways of dismembering
the project into smaller parts or by any other means, it shall be ordered to get right, and the project may be suspended from implementation;
for the projects that is wholly or partly funded by state-owned capital, the funds may be suspended from appropriation; and sanctions
shall be given to the persons-in-charge of the project entity that is directly in charge and other persons that are held to be directly
responsible.
Article 35
Where any of the tenderers for bid colludes with each other in bid invitations or wins the bid by means of offering bribes or by fraudulent
means, the bid winning shall be invalidated, and the offender shall be fined not less than 5ut not more than 10f the value
of the bid winning project, and the persons-in-charge of the bid tendering entity who are directly responsible and the persons who
are held to be directly responsible shall be fined not less than 5ut not more than 10 f the fine imposed upon the entity.
If any illegal gains have been incurred, such illegal gains shall be confiscated. If the circumstances are serious, the offender
shall be disqualified from tendering for bids as provided in Article 4 of the present Measures within 1 or 2 years, or even the
business license thereof may be canceled by the administration for industry and commerce. In case any losses have been caused to
the project entity or the bid invitation agency, the offender shall be responsible for making compensations. If any crime has been
constituted, the offender shall be subject to criminal liabilities.
Article 36
In case any bid invitation agency divulges any of the information or materials relating to the bid invitation or bid tendering activities
that shall have been kept secret, or if it colludes with any bid caller or bid tenderer so as to impair the interest of the state,
the general public, or the lawful interests of any other person, it shall be fined not less than 50,000 yuan but not more than 250,000
yuan, and the persons-in-charge of the agency who are directly responsible and other persons who are held to be directly responsible
shall be fined not less than 5ut not more than 10he fine imposed upon the agency. If any illegal gains have been incurred,
such illegal gains shall be confiscated. The SETC shall, according to the seriousness of the offence, punish the offender by giving
a written warning, circulating notices of criticisms, ordering to get right, suspending its qualifications from serving as a bid
invitation agent for rectifications, degradation, and up to removing its qualification of serving as a bid invitation agent. If any
loss has caused to any other person, it shall be responsible for making compensations. If any crime has been constituted, it shall
be delivered to the judicial organs for criminal liabilities.
Article 37
The bid invitations and tenders for bid made by any institution that has failed to obtain the qualifications of bid invitation agency
as provided by the SETC shall be invalidated. If any loss has been caused to any other people, the institution shall be responsible
for making compensations, and shall be punished by the competent administration for industry and commerce. If any crime has been
constituted, the offenders shall be delivered to the judicial organs for criminal liabilities.
Any bid invitation agency that has obtained the qualifications for bid invitation agency violates the provisions of Article 11 of
the present Measures by engaging in any bid invitation agency activities which do not match with its qualifications, it shall be
ordered by the administrative department of bid invitation to get right, and, according to the seriousness of the offence, be given
a punishment of giving written warnings, notices of criticisms, being ordered to make rectifications, being suspended from engaging
in bid invitation agency business for rectifications, being degraded or even being disqualified from serving as a bid invitation
agent. If any loss has been caused to any other person, it shall be responsible for making compensations. if any crime has been constituted,
it shall be delivered to the judicial organs for criminal liabilities.
Article 38
Where any project entity that holds bid invitations by itself violates any of the provisions of any law, administrative regulation
or the present Measures by negotiating with any of the bid tenderers concerning such substantive contents as the price for bid tendering,
or bid tendering plans, etc. or restricts or excludes any other bid tenderer by means of unreasonable conditions so that the competition
between bid tenderers is impaired, it shall be ordered to get right, and may be fined not less than 10,000 yuan but not more than
50,000 yuan. If the result of bid winning has been affected by such act, the bid winning shall be invalid.
Article 39
In case any project entity determines the bid winner beyond the candidates recommended by the bid appraisal committee or determines
the bid winner on its initiative in a project that is subject to bid invitation after all the bids have been rejected by the bid
appraisal committee, the bid winning shall be invalid, and the entity shall be ordered to get right and may be fined not less than
5ut not more than 10he value of the bid winning project. The persons-in-charge of the project entity who are directly responsible
and other persons who are held to be directly responsible shall be given a sanction according to law.
Article 40
In case any expert of the bid appraisal committee is absent without leave in the process of bid appraisal so that the normal appraisal
of bids is affected, or if he fails to perform his duties impartially in the process of bid appraisal, or accepts the property or
any other good of any bid tenderer or any other interested party, or if he divulges any information of appraising and comparing bids,
the recommendation of candidates for bid winning, or any other information relating to the bid appraisal, he shall be given a warning
with the property accepted being confiscated, and may be fined not less than 3,000 yuan but not more than 10,000 yuan. The members
of the bid appraisal committee who commits any of the illegal acts as mentioned above shall be disqualified and may not participate
in any of the bid appraisal of the projects as described in Article 4 of the present Measures. If any crime has been constituted,
the offender shall be delivered to the judicial organs for criminal liabilities.
Article 41
If, after the bid winning notices have been sent, the project entity fails to enter into contracts with the bid winners according
to the bid invitation documents and the bidding documents of the bid winners, or if the project entity and the bid winners enter
into any agreement that is substantially incompatible with the contracts, the project entity shall be ordered to get right and may
be fined not less than 5ut not more than 10he value of the bid won. If any loss has been caused to the bid winner, it shall
be responsible for making compensations.
Article 42
In case, with the exception of failing to perform the contract due to force majeure, any bid winner fails to perform the contractual
obligations, the caution money for performance shall not be returned, and it shall be disqualified from winning the bid. If the losses
caused to the project entity exceeds the amount of caution money for performance, it shall compensate for the excess. If it fails
to submit the caution money for performance, it shall be responsible for compensating for the losses of the project entity.
If any of the illegal act as described in the preceding paragraph is serious, the offender shall be disqualified from tendering for
the bids as provided in Article 4 of the present Measures, or the business license thereof may even be canceled.
Chapter VI Supplementary Provisions
Article 43
The documents presented for archivist purposes as provided in the present Measures shall be validated automatically without the ratification
of the administrative department of bid invitation.
Article 44
The power to interpret the present Measures shall remain with the SETC.
Article 45
The present Measures shall enter into force as of December 1, 2002. In case any of the provisions promulgated by the SETC prior to
the present Measures conflicts with the present Measures, the present Measures shall prevail.
Appendixes:
I. Checklist of Purchase for Fixed Asset Investment Projects in the Industrial and Commercial Sectors(omitted)
II. Attached Table for Archivist Filing of Bid Invitation of Fixed Asset Investment Projects in the Industrial and Commercial Sectors(omitted)
III. Report for Appraisal of Fixed Asset Investment Projects in the Industrial and Commercial Sectors(omitted)
IV. Authorized Supervision Certificate of Fixed Asset Investment Project in Industrial and Commercial Sectors(omitted)
V. Form of Feedback from the Clients of Fixed Asset Investment Projects in Industrial and Commercial Sectors(omitted)
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The State Economy and Trade Commission
2002-10-29
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Decree of the State Drug Administration
No.35
The Measures for the Administration of Drug Registration (for trial implementation) were adopted at the executive meeting of the State
Drug Administration on October 15, 2002 and are hereby promulgated. These Measures shall enter into force on December 1, 2002.
Director of the Administration Zheng Xiaoyu
October 30, 2002
Measures for the Administration of Drug Registration (for trial implementation)
Chapter I Principle Provisions
Article 1
In order to guarantee the safety, effectiveness and controllable quality of drugs, and to regulate the drug registration, these Measures
are formulated in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Drug
Administration Law), and the Implementation Regulations of the Drug Administration Law of the People’s Republic of China (hereinafter
referred to as Implementation Regulations).
Article 2
These Measures shall apply to the drug development and clinic study, the application for drug clinic study, drug manufacturing or
import, as well as the relevant drug registration, inspection, supervision and administration undertaken within the People’s Republic
of China.
Article 3
Drug registration shall refer to the examination and approval process by conducting systematic evaluation of the safety, effectiveness
and controllability of quality of the drugs to be marketed, and by making the decision on whether or not to approve the drug clinic
study, drug manufacturing or import, the process shall include the examination and approval of the contents indicated in the certifications
of approval for application for drug alteration and in the attachments thereof.
Article 4
The state encourages the study and development of new drugs, and employs accelerated examination and approval for new drugs developed
and new drugs treating complicated and serious diseases.
Article 5
The State Drug Administration (hereinafter referred to as SDA) shall be in charge of the administration of drug registration throughout
the country, and be responsible for the examination and approval of drug clinic study, drug manufacturing and import.
The drug administrations of the provinces, autonomous regions and municipalities directly under the Central Government shall, upon
the entrustment by the SDA, examine the completeness, normalization and authenticity of the application materials for drug registration.
Article 6
An applicant for drug registration (hereinafter referred to as applicant) shall refer to an institution that files the application
for drug registration, bears the corresponding legal liabilities, and holds the certifications of approval for drugs after the application
is approved. A domestic applicant shall be an institution with legal person status that legally registered within China, and an overseas
applicant shall be a legal overseas drug manufacturer. For an overseas applicant, its work office stationed in China or an agency
within China commissioned by it shall make the drug registration for it.
The personnel handling the applications for drug registration shall be the corresponding professionals, and shall be familiar with
the laws and regulations on and the technical requirements for the administration of drug registration.
Chapter II Application for Drug Registration
Article 7
Application for drug registration shall include the application for new drugs, application for drugs with existing state standards,
application for imported drugs, and the supplementary application thereof. For a domestic applicant, the procedures for application
for new drugs and application for drugs with existing state standards shall be followed, for an overseas applicant, the procedures
for application for imported drugs shall be followed.
Article 8
Application for new drugs shall refer to the application for registration of drugs that haven’t been marketed within China. If the
type of preparation or the route of administration of any drugs that have been marketed is changed, the said drugs shall be administered
as new drugs.
Application for drugs with existing state standards shall refer to the application for registration of the drugs for which the SDA
has promulgated official standards.
Application for imported drugs shall refer to the application for registration of the drugs that are manufactured overseas and marketed
in China.
Supplementary application shall refer to the application for alteration, adding or cancellation of the approved matters or contents
after the applications for new drugs, drugs with existing state standards or imported drugs have been approved. If an application
for registration of the drugs during the examination and approval or an approved application for clinical study needs to be altered
correspondingly, or if transferring the new drug technologies, repackaging the imported drugs, and formalizing the tentative drug
standards, the procedures for supplementary application shall be followed.
Article 9
An applicant shall file the application for drug registration with the drug administration of the province, autonomous region or
municipality directly under the Central Government where it is located, and shall submit the relevant materials and drug samples;
in case of an application for registration of imported drugs, the applicant shall file the application with the SDA.
Article 10
If two or more entities apply for registration of new drugs as a joint applicant, they shall file the application with the drug administration
of the province, autonomous region or municipality directly under the Central Government where the drug manufacturing enterprise
is located; if the applicant entities are all drug manufacturing enterprises, they shall file the application with the drug administration
of the province, autonomous region or municipality directly under the Central Government where the drug manufacturing enterprise
that applies for the preparation is located; if none of the applicant entities are drug manufacturing enterprises, they shall file
the application with the drug administration of the province, autonomous region or municipality directly under the Central Government
where the sample is trial-produced.
Article 11
For the drugs applying for registration or the prescriptions or techniques used, the applicant shall provide the patent in China
and explanations on its ownership, submit a guaranty of no infringement upon the patents of others, and promise to be responsible
for the possible infringement consequences.
Article 12
Where any dispute arises after the application for drug registration is approved, the parties shall settle the dispute through consultation
by themselves, or through judicial bodies or patent administrative bodies pursuant to the relevant laws and regulations.
Article 13
With respect to any drug to which a Chinese patent has been granted, other applicants may file an application for registration within
2 years before the expiration of the patent of that drug. The SDA shall make examination pursuant to these Measures, and, if the
provisions are met, approve the manufacturing or import after the patent expires.
Article 14
According to Article 35 of the Implementation Regulations, with respect to the undisclosed experiment data or other data independently
obtained and submitted by the manufacturer or seller that has acquired the license for manufacturing or selling drugs containing
new chemical compounds, the SDA shall not approve any application for using such undisclosed data without the consent of the licensed
applicant within 6 years from the day of approval for the license. But if other applicants submit the data independently obtained
by themselves, the SDA may approve them.
When applying for drug registration, other applicants shall promise that all the experiment data are independently obtained by themselves
and shall guarantee the authenticity of the data.
Article 15
With respect to the drugs processed in China upon the commission of overseas drug manufacturers, but not sold or used in China, the
domestic drug manufacturing enterprise that processes the drug shall file the application with the drug administration of the province,
autonomous region or municipality directly under the Central Government where it is located. The drug administration of the province,
autonomous region or municipality directly under the Central Government shall approve the application if the provisions are met,
but shall not issue the registered number of approval for the drug.
Chapter III Investigational Study of New Drugs before They Are Clinically Used
Article 16
Investigational study of new drugs conducted for application for drug registration shall include the synthetic techniques, extraction
methods, physical and chemical properties, purity, choosing of form of this drug, selection of prescriptions, preparation techniques,
inspection methods, quality indications and stability, pharmacology, toxicology, nuclein animal dynamics etc. As for Chinese medicine
preparations, the sources and processing of the original medicine materials etc shall also be included; as for biologic products,
the quality standard, preservation conditions, inheritance stability and immunological study of the initial materials such as microbial
and toxic species, cell line or organism etc shall also be included.
Article 17
Relevant administration provisions shall be executed in the Investigational study of new drugs, and the Criterions for the Quality
Control of Non-clinical Study of Drugs must be executed in the safety evaluation study.
Article 18
An institution engaging in drug study and development must have the personnel, site, equipment, instruments and management system
accommodating to the experiment and study projects; the animals, reagents, and raw materials for experiment use shall meet the relevant
provisions and requirements of the state, and the authenticity of all the experiment data and materials shall be guaranteed.
Article 19
For a separate application for the chemical raw material medicines used in the drug preparations and for the Chinese medicine materials
and the crude slices of Chinese medicine subject to the administration by the registered number of approval, the registered number
of approval for the drug, the Registration Certificate of Imported Drugs or the Registration Certificate of Pharmaceutical Products
is required, the raw material medicines must be obtained through legal channels. Where the raw material medicines don’t have the
registered number of approval, the Registration Certificate of Imported Drugs or the Registration Certificate of Pharmaceutical Products,
the approval of the SDA is required.
Article 20
Where an applicant entrusts any other institution to conduct drug study, separate experiment, testing, trial manufacturing or production
of samples etc, it shall sign a contract with the trustee. The applicant shall be responsible for the authenticity of the drug study
data in the application materials.
Article 21
If the application materials for drug registration include any drug experiment and study materials submitted by any overseas drug
study institution, there must be attached explanations produced by that overseas drug study institution on the projects and page
numbers of the materials provided, and the certifications which can prove that the institution has been legally registered and notarized
overseas, and the attached materials may be used as the application materials only after they have been acknowledged by the SDA.
The SDA shall send personnel to make on-spot examinations according to the needs.
Article 22
When inspecting drug study according to the needs, the SDA and the drug administrations of a province, autonomous region or municipality
directly under the Central Government may request the applicant or the drug study institution undertaking the experiment to conduct
respeated experiment according to the projects, methods and data specified in the application materials, and shall send personnel
to examine the experiment on the spot; or an institute for drug control or other drug study institution may be entrusted to make
the repeated experiment.
Article 23
Investigational study of new drugs shall be conducted by referring to the relevant technical guiding principles promulgated by the
SDA. Where the applicant adopts other evaluation methods and techniques in the experiment, it shall submit the materials that can
prove the scientificity of such methods and techniques.
Chapter IV Clinical Study of Drugs
Section I Basic Requirements
Article 24
Clinical study of drugs includes clinical trial and bioequivalence trial.
Clinical study of drugs must be approved by the SDA before it is carried out, and must follow the Criterions for the Quality Control
of Clinical Trial of Drugs.
Article 25
For the application for registration of new drugs, clinical trial or bioequivalence trial shall be conducted.
Generally, it is not necessary to conduct clinical study for the application for registration of drugs with existing state standards.
If clinical study is needed, as for the chemical drugs, the applicant may conduct only the bioequivalence trial; as for Chinese traditional
patent medicines and biological products the quality of which needs to be controlled by techniques and standards, the clinical trial
shall be conducted.
In supplementary application, it is needed to conduct clinical study if new indications are added for any drug already on the market
or if the manufacturing techniques of the drug are altered significantly.
Article 26
Clinical trial is divided into phases I, II, III, and IV. For the application for registration of new drugs, Clinical trial of phases
I, II, and III shall be conducted, under certain circumstances, the applicant may only conduct clinical trial of phases II and III
or only phase III.
Phase I clinical trial: preliminary trial on clinical pharmacology and human body safety evaluation, which observes the degree of
tolerance of human body against the new drug and the drug dynamics, and provides basis for working out the administration scheme.
Phase II clinical trial: preliminary evaluation of the treating effect, the purpose of which is to preliminarily evaluate the treating
effect and safety of the drug on the target patient with the applicable disease, and also to provide basis for the determination
of study design and dosage administration scheme for phase III clinical trial. Various forms may be employed for the study design
of this phase in accordance with the specific study purpose, including randomized controlled clinical trial.
Phase III clinical trial: confirmation phase of the treating effect, the purpose of which is to further verify the treating effect
and safety of the drug on the target patient with the applicable disease, to evaluate the relationship between interest and risk,
and to eventually provide adequate basis for the application for drug registration for gaining approval. Generally, the trial shall
be a randomized controlled trial with sufficient samples.
Phase IV clinical experiment: application study conducted by the applicant independently after the new drug comes into the market,
the purpose of which is to examine the curative effect of the drug and the adverse reactions when it is widely used; to evaluate
the relationship between interest and risk when the drug is used in ordinary or special groups; and to improve the dosage administration
etc.
Article 27
The number of cases experimented in drug clinical study shall be in accordance with the study purpose and meet the relevant statistics
requirements and the minimum clinical study case number specified in these Measures. As for rare diseases, special diseases or other
circumstances where it is needed to reduce clinical study cases or to exempt the clinical trial, examination and approval by the
SDA is required.
Article 28
With respect to bacterins or other special drugs prepared at the phase of seed selection of bacterial or toxic species, if there
are no suitable animal models and the laboratories can not evaluate the curative effect thereof, the applicant may apply for clinical
study with the SDA on the premise that the safety of the experimented person is secured.
Section II Requirements Before the Study
Article 29
After a drug clinical study has been approved, the applicant shall select, from the institutions qualified for drug clinical trial,
an institution to undertake the drug clinical trial, decide on, through consultation, the entity responsible for the clinical study,
the major researchers and the entities participating in the clinical study.
Article 30
The applicant shall sign a clinical study contract with the selected entity responsible for and the entities participating in the
clinical study, supply the draft of letter of consent with knowledge of the experimented person and the manuals for the researchers
conducting the clinical trial, perfect the clinical study scheme by referring to the relevant technical guiding principles, and request
the ethic committee of the clinical trial institution to examine the scientificity of the clinical study and the ethic issues involved.
Article 31
The applicant shall provide the selected clinical study entities with free medicines for use in clinical study and drugs for comparison
use (except for phase IV clinical trial), enclose the sample inspection report; and bear the expenses needed for the clinical study.
Article 32
Drugs for use in clinical study shall be prepared in workshops meeting the conditions provided for in the Criterions for the Quality
Control of Drug Manufacturing. The preparing process shall strictly follow the Criterions for the Quality Control of Drug Manufacturing.
The SDA or the entrusted drug administration of the province, autonomous region or municipality directly under the Central Government
may make on-spot examinations according to the needs.
Article 33
An applicant may inspect the drugs for use in clinical study by itself according to the drug standards determined by the SDA, either
may it entrust the National Institute for the Control of Pharmaceutical and Biological Products or an institute for drug control
designated by the SDA to make the inspection, the drugs can be used in clinical study only after they have passed the inspection.
The SDA may designate an institute for drug control to make selective inspection over the drugs for use in the clinical study.
Vaccine products and blood products, and other biological products as well as overseas-manufactured drugs for use in clinical study
provided for by the SDA, must be inspected by the institutes for drug control designated by the SDA, and can be used in clinical
study only after they have passed the inspection. The applicant shall bear all the responsibilities for the quality of the drugs
for clinical study use.
Article 34
An applicant shall, before carrying out the clinical study of drugs, submit the clinical study scheme and the names of the principal
researchers of the entity responsible for the clinical study, the list of the participating entities and the researchers thereof,
the letter of approval of the ethics committee, the sample of the letter of consent with knowledge to the SDA for record, and shall
submit them to the drug administrations of the provinces, autonomous regions or municipalities directly under the Central Government
where the clinical study entities are located.
Section III Administration of Clinical Study
Article 35
In the clinical study of drugs, the applicant shall appoint personnel with certain professional knowledge to supervise the implementation
of the Criterions for the Quality Control of Clinical Trial of Drugs.
Article 36
If an applicant finds out that any clinical researcher violates the relevant provisions or fails to carry out the clinical study
scheme, it shall urge the researcher to correct; if the circumstances are serious, it may demand suspension or termination of the
clinical study, and shall report to the SDA and the drug administration of the relevant province, autonomous region or municipality
directly under the Central Government.
Article 37
After finishing each phase of clinical trial, the applicant shall submit the clinical study and statistics analysis report to the
SDA and to the drug administration of the relevant province, autonomous region or municipality directly under the Central Government.
If the period of clinical study exceeds 1 year, the applicant shall submit a report on the clinical study process to the SDA and the
drug administration of the relevant province, autonomous region or municipality directly under the Central Government.
Article 38
The clinical study of drugs shall be carried out within 2 years from the day of approval. If it hasn’t been carried out within that
period, the original certifications of approval shall be invalidated automatically; a new application shall be filed if it is still
needed to carry out the clinical study.
Article 39
The entities and personnel participating in the clinical study shall be familiar with the properties, functions, curative effect
and safety of the drugs for clinical trial use; understand the responsibilities and obligations of clinical researchers; obtain the
letter of consent with knowledge voluntarily signed by the experimented person; and make the clinical study records timely, accurately
and truthfully.
Article 40
If an applicant violates the Criterions for the Quality Control of Clinical Trial of Drugs or requests to change the data or conclusion
of the trial, the entities and personnel participating in the clinical study shall report to the drug administration of the relevant
province, autonomous region or municipality directly under the Central Government and the SDA.
Article 41
The entities undertaking the clinical study and the clinical researchers are obliged to take necessary measures to guarantee the
safety of the experimented person.
Clinical researchers shall pay close attention to the occurrence of any adverse reaction case involving the drugs for clinical study
use, take proper treating measures for the experimented person without delay, and write the case into the records.
If any serious adverse reaction case occurs in the course of a clinical study, the researchers shall, within 24 hours, report to the
drug administration of the relevant province, autonomous region or municipality directly under the Central Government and the SDA,
and shall make a timely report to the ethics committee.
Article 42
For the clinical studies that have been approved, the SDA and the drug administrations of the relevant provinces, autonomous regions
and municipalities directly under the Central Government shall conduct regular or specific on-spot examinations or data checks.
Article 43
If any of the following cases occurs in the course of a clinical study, the SDA may request the applicant to modify the clinical
study scheme, or to suspend or terminate the clinical study:
(1)
The ethics committee fails to perform its duties;
(2)
Safety of the experimented person can’t be effectively guaranteed;
(3)
A serious adverse reaction case hasn’t been reported within the prescribed time limit;
(4)
Report on the clinical study progress is not submitted in timely and truthfully;
(5)
Approved clinical study fails to acquire evaluable results within 2 years after the scheduled end of the study;
(6)
There is, already, evidence proving that the drugs for clinical trial use are ineffective;
(7)
Drugs for clinical trial use encounter quality problems;
(8)
Frauds are committed in the clinical study;
(9)
Other cases of violation of the Criterions for the Quality Control of Clinical Trial of Drugs.
Article 44
Where the SDA makes the decision of modifying the clinical study scheme, ordering suspension or termination of the clinical study,
the applicant or the entity conducting the clinical study shall execute such decision. If they have any objections, they may present
their opinions within 10 days and explain the reasons in written form.
Article 45
If large-scope and unanticipated adverse reactions or serious adverse reaction cases occur in a clinical study, or there has been
evidence that can prove the drugs for clinical trial use have serious quality problems, the SDA or the drug administration of the
relevant province, autonomous region or municipality directly under the Central Government may take urgent measures and order suspension
or termination of the clinical study, the applicant and the clinical study entity must stop the clinical study immediately.
Article 46
The use of drugs for clinical trial use shall be taken care of by the clinical researchers. The researches must guarantee that all
the drugs for study use are only used on the experimented persons, and the method of use and dosage shall conform to the study scheme.
The researchers may not pass the drugs for study use to any person not participating in the clinical study. Drugs for clinical study
use may not be marketed.
Article 47
If an overseas applicant wishes to conduct an international multi-center clinical study of drugs, it shall file an application with
the SDA pursuant to these Measures and meet the requirements of the following provisions:
(1)
The drugs for clinical study use shall be drugs that have been registered overseas or have entered Phase II clinical trial; the SDA
will not accept any application filed by an overseas applicant for international multi-center clinical study of new preventive vaccine
drugs not yet registered overseas;
(2)
The SDA may, when granting approval for the conduction of international multi-center clinical study of drugs, request the applicant
to carry out Phase I clinical trial in China according to the needs;
(3)
In the conduction of international multi-center clinical study of drugs in China, if serious adverse reactions and unanticipated
adverse reactions relating to such drugs are found in any country, the applicant shall report to the SDA timely pursuant to the relevant
provisions;
(4)
After a clinical study is ended, the applicant shall submit the complete clinical study report to the SDA;
(5)
Where the data obtained in an international multi-center clinical study of drugs are used in the application for drug registration
in China, the provisions relating to clinical study provided for in the Drug Administration Law, the Implementation Regulations,
and these Measures must be met, and the applicant must submit all the study materials of the international multi-center clinical
study.
Chapter V Application and Examination & Approval of New Drugs
Section I Basic Requirements
Article 48
The materials submitted for the application for registration of new drugs shall be complete and normative, and the data must be true
and reliable; the documentary materials quoted shall be marked with the post_title of the work, post_title of the publication, as well as the
volume, issue and page etc; the documentary materials not publicly published shall be accompanied with the certifications of permission
of use by the owner of the materials. Materials in foreign languages shall be accompanied with Chinese translations pursuant to the
requirements.
Article 49
The SDA shall make an accelerated examination and approval with respect to the applications for the following new drugs:
(1)
New Chinese medicine materials, effective components extracted from Chinese medicines or natural drugs, as well as the preparations
of those components;
(2)
Chemical raw materials medicines, as well as the preparations and biological products thereof, that haven’t been approved to be marketed
home and abroad;
(3)
New drugs that fight against AIDS virus and that are used in the diagnosis and prevention of AIDS, new drugs treating malignant tumours
and rare diseases etc;
(4)
New drugs treating the diseases that can’t be cured by effective means yet.
Article 50
The drug administration of a province, autonomous region and municipality directly under the Central Government shall, after receiving
an application for registration of any new drug listed in Article 49 of these Measures, make the examination and give opinions on
whether that application meets the conditions for accelerated examination and approval. The SDA shall determine whether to make an
accelerated examination and approval for that application for new drug upon the acceptance of it.
Article 51
With respect to any new drug jointly developed by several entities, the application for registration may be filed by one entity among
them, and the other entities may not file the application any more. Except the drugs listed in Subparagraphs 1) and 2) of Article
49 of these Measures, after the application for a new drug is approved, each category of such drug may only be manufactured by one
entity, and different specs of the same category may not be manufactured by different entities.
Article 52
In the examination process of a new drug, if the technical requirements for that new drug are changed because the same category of
drug is allowed to go on the market overseas, the original technical requirements shall remain unchanged.
Section II Examination & Approval of Clinical Study of New Drugs
Article 53
After finishing the investigational study of new drugs, an applicant shall fill in the Application Form for Drug Registration, and
faithfully submit the relevant materials and drug samples to the drug administrations of the province, autonomous region or municipality
directly under the Central Government.
Article 54
The drug administration of the province, autonomous region or municipality directly under the Central Government shall make an examination
of form of the application materials, organize an on-spot investigation of the manufacturing process and conditions, select samples
for inspection use, and send notice on registration inspection to the designated institute for drug control. The administration shall,
after finishing the aforesaid work, submit the examination opinions, investigation report and application materials to the SDA, and
notify the applicant.
Article 55
The institute for drug control receiving the notice on registration inspection shall make an inspection on the selected samples,
check the drug standards of the application, and submit the inspection report and check opinions to the SDA within the prescribed
time limit, and shall send those documents to the drug administration of the province, autonomous region or municipality directly
under the Central Government that sent the notice on inspection and to the applicant.
Article 56
With respect to the application materials for clinical study of new drugs submitted by the drug a
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The Ministry of Foreign Trade and Economic Cooperation, the State Administration of Foreign Exchange
Decree of the Ministry of Foreign Trade and Economic Cooperation and the State Administration of Foreign
No. 32
Interim Measures for Joint Annual Inspection of Overseas Investment are hereby promulgated and shall be come into force as of the
day of January 1, 2003.
The Minister of Ministry of Foreign Trade and Economic Cooperation Shi Guangsheng
The Minister of the State Administration of Foreign Exchange, Guo Shuqing
October 31, 2002
Interim Measures for Joint Annual Inspection of Overseas Investment
Chapter I General Provisions
Article 1
The measures are aimed to enhance the macro-control of, command the variations of, and promote the sound development of overseas investment.
Article 2
A joint annual inspection is applied to overseas investment by the country. The Ministry of Foreign Trade and Economic Cooperation
(hereinafter referred to as the MOFTEC) and the State Administration of Foreign Exchange (hereinafter referred to as the SAFE) are
responsible for the formulation of annual inspection methods and relevant organization, coordination and supervision work.
Article 3
Overseas enterprises shall accept annual inspection through their investing principals.
Article 4
The “oversea enterprises” mentioned in the Measures refer to those enterprises (except financial ones) set up by corporate legal persons
(hereinafter referred to as “investing principals”) of China.
Chapter II Time, Items and Procedures of the Annual Inspection
Article 5
The department (commissions and bureaus) of foreign trade and economic activities of each province, autonomous region and municipalities
directly under the Central Government, and foreign exchange sub-branches take charge of the annual inspection of overseas investment
by local enterprises. Central enterprises shall take charge of the annual inspection of their respective overseas investment, except
the part concerning foreign exchange, which should be under the foreign exchange bureaus (foreign exchange administrations) of the
enterprise’s location (hereinafter referred to as “annual inspection agencies”).
Article 6
The work time for annual inspection extends from April 1 to June 15 each year.
Article 7
items subject to annual inspection:
I.
Status of overseas investment.
II.
The appraisal of overseas enterprises by overseas business organizations of China.
III.
Observation of overseas-investment-related regulations of China by investing principals and their oversea enterprises.
Article 8
Procedures of the annual inspection
I.
The report of annual inspection be co-prepared by the MOFTEC and the SAFE and be published on the web page for downloading by domestic
investing principals (for a sample see Attachment I).
II.
The downloading should be completed within the stipulated time and the information filled in concerning overseas enterprises should
be true and valid.
III.
A copy of the finished document should be submitted to the departments (commissions or bureaus) of foreign trade and economic activities
and foreign exchange bureaus (foreign exchange administrations).
Chapter III Auditing of Annual Inspection
Article 9
The scoring standards specified in the Measures should serve as the basis for determining the grades (1, 2 and 3) as the result of
the inspection by annual inspection agencies (see Attachment II for relevant scoring standards).
Article 10
The certificate of annual inspection uniformly printed by the country is to be sealed for this specific purpose by the annual inspection
agencies upon the determining of the grade and then be handed over to the investing principal for keeping (for a sample of the certificate
see Attachment III).
Article 11
The report (a copy) and result of annual inspection should be submitted to the MOFTEC by the annual inspection agencies before June
15. A working report on the annual inspection is to be submitted to the MOFTEC and the SAFE before June 30.
Article 12
The MOFTEC is responsible for notifying finance, customs, taxation, foreign affairs, banking, insurance and other departments of the
annual inspection results.
Article 13
The inspection is carried out regularly each year and there shall be no other focused inspection of any form on overseas investment.
Article 14
No fee should be charged by any department in the name of annual inspection.
Chapter IV Results of Annual Inspection
Article 15
The result is valid within a year since the day of specialized sealing for annual inspection.
Article 16
The investing principal, after the overseas enterprise obtains the certificate in the annual inspection, should present the certificate
of annual inspection to the MOFTEC and relevant departments while undergoing procedures concerning overseas investment.
Article 17
Priority is to be given to grade 1 obtainer in preferential and supportive treatments concerning overseas investment; priority is
also to be given by concerned departments in procedures for foreign exchange, customs, taxation and cross-border movement of staff.
Article 18
Grade 2 obtainers do not enjoy preferential or supportive treatments.
Article 19
Grade 3 obtainers do not enjoy preferential or supportive treatments and are allowed a one-year period for rectification and improvement,
any new investment is forbidden within one year in case of another grade 3 at the next annual inspection.
Chapter V Penalty Provisions
Article 20
The MOFTEC and relevant departments are to take the following measures for those not declaring for annual inspection:
I.
Suspend accepting applications of the investing principal for overseas-investment-related foreign exchange buying or payment and overseas
guarantee.
II.
Do not accept new applications of the investing principal for setting up overseas enterprises.
III.
Do not accept applications for sending staff overseas.
Article 21
Sampling reviews are to be performed by the MOFTEC in joint efforts with relevant departments and a time limit can be imposed on relevant
agencies for rectification and improvement if the inspection results are not in accordance with the facts. The treatments provided
in Article 20 should be executed in case of serious consequences.
Chapter VI Supplementary Provisions
Article 22
The Measures shall serve as reference with regard to the annual inspection of domestic-invested enterprises in HK, Macao and Taiwan.
Article 23
“Certificate of approval for overseas processing and assembling enterprises using exported materials or parts” must have the certificate
of annual inspection as a precondition for its annual auditing procedures.
Article 24
The Measures are subject to the interpretation of the MOFTEC.
Article 25
The Measures shall enter into force as of January 1, 2003.
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The Ministry of Foreign Trade and Economic Cooperation, the State Administration of Foreign Exchange
2002-10-31
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The People’s Bank of China
Order of the People’s Bank of China
No.9
The Administrative Rules for Financial Statistics which was adopted at the 26th Executive Meeting of the president of the People’s
Bank of China on June 17, 2002 is hereby promulgated, and shall enter into force as of December 15, 2002.
President Dai Xianglong
November 1, 2002
Administrative Rules for Financial Statistics
Chapter I General Provisions
Article 1
These rules are formulated according to the “Statistic Law of the People’s Republic of China”, “Implementation Rules of the Statistic
law of the People’s Bank of China”, “Law on the People’s Bank of China of the People’s Republic of China”, “Commercial Banking Law
of the People’s Republic of China”, “Rules on punishment of financial irregularities”, so as to promote the development of financial
business and institutional reform of financial regulatory framework, reinforce administration of financial statistics, standardize
financial statistic practice, and improve the quality of financial statistics.
Article 2
These rules are applicable to the People’s Bank of China, as well as domestic and foreign-funded financial institutions approved by
the People’s Bank of China engaged in financial business, including policy banks, commercial banks, urban credit cooperatives, rural
credit cooperatives, trust and investment companies, finance companies of enterprise groups, financial leasing companies, financial
asset management companies, postal savings bureau, etc.
Article 3
Financial statistics in these rules refers to the following activities: The statistic units of the People’s Bank of China and financial
institutions collect, process and analyze information on financial businesses, provide statistic information and advisory comments,
exchange and share statistic information, administer and supervise the conduct of financial statistics, etc. Financial statistics
include monetary statistics, statistics of both local and foreign currency denominated loans flow, statistics of cash flow, accumulative
statistics of loans extending and collecting, financial supervision statistics, statistics of funds flow, financial market statistics,
statistics of financial businesses such as banking intermediary business and other specific statistics.
Statistic units in these rules refer to working units within the People’s Bank of China and financial institutions that are engaged
in financial statistics.
Article 4
The basic tasks for the conduct of financial statistics are: Complete statistics of various financial businesses in a timely, accurate
and comprehensive manner. Collect, process and accumulate statistic information on financial sector and national economy. Conduct
statistic survey, analysis and forecast. Carry out statistic regulation and inspection according to the law; provide statistic information
and advisory comments for the state and the financial sector to make macroeconomic policy decisions, monitor the developments of
the national economy and the financial sector, financial supervision and management. Provide statistic information to the general
public. Exchange information with international community and provide statistic information to relevant international financial organizations.
Article 5
Conduct of financial statistics shall adhere to principles of being objective, scientific, consistent and timely.
Article 6
An administrative system with centralized administration and hierarchical accountability is to be adopted in the conduct of financial
statistics. The People’s Bank of China assumes the authority to organize, supervise, monitor, regulate and coordinate the conduct
of financial statistics all over the country.
Article 7
Financial statistics shall be gradually automated, standardized and uniformed with the support of a computer-based network.
Article 8
Compliance with international practices of financial statistics shall be speeded up, with processing and disclosing of financial statistic
data in line with the international standards being gradually achieved.
Article 9
Financial statistics is a comprehensive statistics based on charts of accounts and information of various accounts, which builds a
foundation for a variety of statistic statements.
Chapter II Administration of Financial Statistic data and Statistic Survey
Article 10
The head office of the People’s Bank of China regulates national statistic statements of the financial sector, and it is responsible
for the compiling, publishing and revoking of national statistic statements of the financial sector. Branches of the People’s Bank
of China are in charge of surveillance and inspection of the observance of financial institutions within their jurisdiction with
the administrative rules for financial statements and financial statistic data.
Article 11
Headquarters of financial institutions (corporations, administrations) are responsible for supervision of financial statistic statements
of their own corporations and the compiling and revoking of national statistic statements within their own institutions, whereas
they need to report such actions to the head office of the People’s Bank of China for record-keeping.
Article 12
Regional branches, operation offices and branches in the capital cities of provinces of the People’s Bank of China may compile regional
statistic statements but need to file with the head office of the People’s Bank of China for record-keeping. Provincial branches
of financial institutions may compile regional statistic statements of their own systems, whereas they need to report to the regional
branches and branches in the capital cities of provinces of the People’s Bank of China for record-keeping. Branches of the People’s
Bank of China below capital city level and branches of financial institutions below provincial level are not allowed to compile regular
regional statistic statements. However, they may compile ad hoc regional statistic statements according to the actual need with the
approval of their superiors. The duration of ad hoc statistic statements shall not exceed one year.
Article 13
While conforming to the uniform statistic categories and indicators determined by the head office of the People’s Bank of China, regional
branches, operation offices and branches in the capital cities of provinces of the People’s Bank of China as well as the head office
and provincial branches of financial institutions may add new statistic categories and indicators as needed. According to their needs
in financial supervision, regional branches, operation offices and branches in the capital cities of provinces of the People’s Bank
of China may require financial institutions within their jurisdiction to add new categories and indicators, appendix tables, books
and original statistic records as needed.
Article 14
The People’s Bank of China and financial institutions, as well as their branches, shall strictly control the compilation and release
of ad hoc statistic statements and try to reduce the number of ad hoc statistic statements.
Article 15
The People’s Bank of China shall formulate uniform standards for financial statistics, so as to ensure the standardization of definitions
of indicators, methods of calculations, catalog of classification, format of survey forms and statistic code adopted in the statistic
survey.
Article 16
The People’s Bank of China’s collection of financial statistic data from financial institutions is exclusively regulated by the statistic
units of the People’s Bank of China. Reporting of statistic data related to unified financial statistic indicators (consolidated)
of the People’s Bank of China by the statistic units of financial institutions to the People’s Bank of China is exclusively regulated
by financial institutions themselves, so as to ensure the accuracy and consistency of statistic data.
Article 17
Statistic units of the People’s Bank of China and financial institutions shall enhance management on the data of financial statistics,
establish and improve mechanisms of reviewing, processing, handover and recording of financial statistic data.
Article 18
As to statistic statements and statistic survey forms made and circulated in violation of the state statistic laws, regulations and
these rules, the statistic units of the People’s Bank of China and financial institutions shall have the right to decline to fill
in.
Article 19
National or regional statistic survey shall be with participation of relevant financial institutions coordinated by the People’s Bank
of China. Financial institutions are responsible for organization of statistic survey within their own systems.
Chapter III Release of Financial Statistic Data
Article 20
Release of main contents of financial statistic data shall be gradually brought in line with international practices, so as to accelerate
the improvement of transparency.
Article 21
The People’s Bank of China shall release national financial statistic data regularly (within 20 days after the end of each month,
monthly data of financial statistics such as monetary supply, credit flow and asset/liabilities shall be released through the media
and the web site of the People’s Bank of China). Regional branches, operation offices and branches in the capital cities of provinces
of the People’s Bank of China shall release financial statistic data on a regular basis within their jurisdiction according to the
rules laid by the head office of the People’s Bank of China and file with the head office for record-keeping. Statistic figures of
some particular categories can only be released with the approval of the president of the branch or operational office.
Release of financial statistic data to the general public by headquarters of financial institutions shall be approved by their Presidents
(General Managers). Release of financial statistic data by branches of financial institutions shall be conducted in accordance with
rules laid by their superior institutions.
Article 22
Release of confidential financial statistic data shall be approved following a hierarchical accountability system.
No entities or individuals shall be allowed to release financial statistic data of normal, high or strict confidentiality without
approval.
Classification of normal, high and strict confidentiality shall be conducted according to the “Rules on Specific Definition of State
Confidentiality and Its Coverage in Financial Activities”.
Release of financial statistic data of strict confidentiality shall be approved by the State Council and conducted by the head office
of the People’s Bank of China. Release of financial statistic data of high confidentiality shall be approved by the head office of
the People’s Bank of China. While releasing financial statistic data of normal confidentiality, release of national statistic data
shall be approved by the head office of the People’s Bank of China, and release of data of financial institutions shall be approved
by their headquarters.
Chapter IV Responsibilities of Financial Statistic Units
Article 23
The head office of the People’s Bank of China shall establish a specialized statistic department, which assumes responsibility for
organization, supervision and coordination of financial statistics across the country. Regional branches, operation offices and branches
in the capital cities of provinces of the People’s Bank of China shall set up specialized statistic units, which are responsible
for supervision and coordination of statistic work in financial institutions within their jurisdiction. County-level branches of
the People’s Bank of China shall set up statistics posts.
Article 24
Headquarters of financial institutions (corporations, administrations) shall set up specialized statistic units to supervise statistic
work within their systems. Establishment of statistic units in branches of the financial institutions shall remain at the discretion
of their headquarters.
Article 25
The statistic units of the People’s Bank of China shall assume the following responsibilities:
(1)
The statistic department of the head office of the People’s Bank of China is responsible for formulating financial statistic regime
and related administrative rules. Regional branches, operation offices and branches in the capital cities of provinces of the People’s
Bank of China may draft their own regulations and the implementation rules according to rules and regulations issued by the head
office and the local situation as well, and file with the head office for record-keeping.
(2)
Organize, supervise, regulate, monitor and inspect statistic work in financial institutions.
(3)
Collect, review, aggregate and compile financial statistic data and statistic statements.
(4)
Collect, process and accumulate financial statistic data and related statistic data of the national economy.
(5)
Provide financial statistic data to relevant authorities, release comprehensive financial statistic data.
(6)
Organize financial institutions’ statistic survey, analysis and forecast.
(7)
Organize and promote standardization and modernization of financial statistics, establish a unified management information system
for financial statistics as well as an efficient and safe transmission network, and ensure information sharing within the financial
sector.
(8)
Organize inspection on compliance of statistic laws and quality of statistics, and training of statistic staff.
(9)
Participate in financial statistic activities both at home and abroad as authorized representatives for the financial sector.
Article 26
Statistic units of financial institutions shall assume the following responsibilities:
(1)
Enforce the financial statistic arrangement and related administrative rules formulated by the head office of the People’s Bank of
China and submit to the supervision and inspection of the People’s Bank of China.
(2)
Formulate statistic rules of their own systems, and organize and regulate the financial statistic work of their own system.
(3)
Collect, aggregate, compile and take care of financial statistic data and statements of their own systems.
(4)
Collect, process and accumulate financial statistic data of their own systems and related statistic data of the national economy.
(5)
Report statistic data, statistic statements, statistic arrangement and statistic files to the People’s Bank of China, provide statistic
data to relevant authorities and release information of financial statistics within their own systems.
(6)
Accomplish statistic surveys assigned by the People’s Bank of China and organize internal statistic surveys, analysis and forecasts.
(7)
Execute the uniform coding of statistic indicators and rules on interface of electronic files.
(8)
Supervise and organize inspections on compliance of statistic rules and regulations and the quality of statistics; train the statistic
staff.
Chapter V Appointment of Statistic Staff and Their Responsibilities
Article 27
Statistic staff shall be appointed according to the following criteria:
(1)
Statistic staff shall have good command of professional ethics, needed basic knowledge of statistics and certain computer skills.
(2)
Statistic staff shall go through pre-assignment training and shall not be assigned to any statistic position without any pre-assignment
training or if they fail to pass that training test. Staff members that are assessed as ineligible for statistic work shall be replaced
immediately.
Article 28
Heads of statistic units in branches of the People’s Bank of China shall only be removed with approval of their superior institutions
in the People’s Bank of China; Head of statistic units in branches of financial institutions shall only be removed with approval
of their superior institutions and shall be filed with the statistic units in local branches of the People’s Bank of China for record-keeping.
In the event of transfer or removal of a statistic staff member, eligible successor shall be selected and the handover process shall
be completed.
Article 29
Branches of the People’s Bank of China and financial institutions shall appoint professional statistic personnel to designated statistic
positions according to relevant rules and actual needs of statistic work..
Article 30
In an institution that has a statistic unit, head of that unit will be the person accountable for statistics. As for an institution
without a statistic unit, its legal representative or head will be the person accountable for statistics. Persons accountable for
statistics shall be held responsible for the integrity of statistic data of their institutions.
Article 31
Statistic staff shall assume the following responsibilities:
(1)
Enforce statistic laws, rules and regulations, report statistic figures in a timely, accurate and integral manner according to rules
and regulations, and compile statistic statements. Any overstatement, concealment, counterfeit or distortion of statistic data is
not allowed.
(2)
Strictly observe the rules on confidentiality.
(3)
Collect, process and provide statistic data.
(4)
Execute statistic survey, analysis and forecasts.
(5)
Operate with statistic computer programs and systems in compliance with rules to ensure the safety of statistic data and files.
(6)
Have the right to request relevant authorities and staff to provide information on financial business, make inquiries the facts and
verify the original data in accordance with the prescribed approval procedures.
(7)
Check the accuracy of statistic data, and have the right to request correction of inaccurate statistic data.
(8)
Refuse to fill in statistic statements that are circulated in violation with rules, report and expose activities in violation of statistic
laws, rules and regulations.
Statistic units of the People’s Bank of China and financial institutions execute the above-mentioned authorities according to statistic
laws, rules and regulations published by the state, free from illegal intervention of any institutions or individuals.
Chapter VI Surveillance and Inspection of Statistics
Article 32
Statistic units of the People’s Bank of China are to conduct regular or irregular surveillance and inspection on financial institutions’
statistic work and observance of statistic laws, rules and regulations, quality and integrity of statistics and the performance of
their statistic work in accordance with laws. The contents and focus of the inspection are to be determined according to the need
of enforcement of statistic laws, rules and regulations.
Statistic units of financial institutions are to supervise and inspect statistic work and observance of statistic laws, rules and
regulations in their own systems under the instruction and coordination of statistic units of the People’s Bank of China at the same
level.
No one is allowed to interfere or hamper the statistic staff’s enforcement of inspection and the independent assessment of the inspection.
Article 33
Statistic units of the People’s Bank of China shall appoint full-time or part-time statistic inspectors that are familiar with relevant
laws, rules and regulations and statistic business.
Article 34
Statistic inspectors shall execute their statistic inspection power with the prescribed terms of reference.
Article 35
Statistic inspection units and inspectors shall have the right to verify and monitor the statistic data used by the inspected institution
and their sources. Statistic inspectors are enpost_titled by these rules to issue “Inquiry Note of Statistic Inspection” to the inspected
financial institutions. The inspected financial institutions shall honestly answer the inquiry within 15 days after the receipt of
the “Inquiry Note of Statistic Inspection”.
Article 36
In the statistic inspection, inspectors may check the accounting reports, other business reports related to statistics and relevant
books and original warrants.
Chapter VII Awards and Penalties
Article 37
The People’s Bank of China and financial institutions shall make regular assessment of performance of their own statistic units, while
the People’s Bank of China shall also assess performance of statistic work in the entire financial sector. The People’s Bank of China
and financial institutions may award the financial statistic staff or units that meet the following criteria in the way of commendation,
merit recording, outstanding merit recording, promotion of post_title, promotion of position or conferment of an honorable post_title. Bonus
may also be granted, which is to be covered by relevant budget according to relevant rules.
(1)
Those who make outstanding contribution to reforming and improving financial statistic regime and methodology.
(2)
Those who make outstanding achievements in accomplishing financial statistic survey, or ensuring timely and accurate reporting of
statistic data.
(3)
Those who achieve important outcome in renovation of statistic analysis and surveillance.
(4)
Those who demonstrate remarkable performance in utilizing and promoting modern statistic information technology.
(5)
Those who make important contribution to enhancing statistic education and vocational training, making statistic research, or upgrading
statistic theories.
(6)
Those who have outstanding performance in fighting against irregularities in violation of statistic laws, rules and regulations.
(7)
Those contribute to reporting and disclosing of statistic irregularities.
Article 38
Statistic units, related units and their staff that have involved in any of the following activities shall be warned by the branches
of the People’s Bank of China above city (prefecture) level and relevant authorities and fined by no more than RMB 30000 yuan. Senior
management, other executives in charge and individuals that are held immediately responsible for these activities shall be disciplined
by their institutions or superior ones in the way of warning, severe warning, demerit recording, severe demerit recording and degrading.
Staff of statistic units and related units of the People’s Bank of China that have any of the following behaviors shall be disciplined
by their working units or superior ones in the way of warning, severe warning, demerit recording, severe demerit recording or degrading.
(1)
Overstate or conceal financial statistic data.
(2)
Counterfeit or distort financial statistic data.
(3)
Refuse to report or delay the reporting of financial statistic data consecutively.
(4)
Violate these rules by formulating and publishing financial statistic survey forms without approval, resulting in significant damage.
(5)
Violate articles of these rules on confidentiality and the “Rules on Specific Definition of State Confidentiality and Its Coverage
in Financial Activities”, breach their authorization and release financial statistic data on their own decision, which entails significant
damage.
(6)
Force or instruct statistic units or staff to counterfeit statistic data.
(7)
Bully or revenge those adhere to statistic principles and report statistic data as they are, or those who report and expose statistic
irregularities.
(8)
When being inspected on statistics, refuse to provide information, provide false information, or remove, hide, destroy original statistic
files, statistic books, statements or other statistics-related data, resulting in significant damages
(9)
Hinder or resist statistic inspection with violence or menace.
(10)
Other behaviors that are identified by regional branches, operation offices and branches in the capital cities of provinces of the
People’s Bank of China.
Article 39
Staff of statistic units and other units that severely violate these rules and have any of the following behaviors shall be warned
by the branches of the People’s Bank of China above city (prefecture) level (City or prefecture level not included) according to
Article 12 of the “Rules on Punishment of Financial Irregularities”, and fined by RMB 100000-500000 yuan. In a very severe case,
the financial institutions may be instructed to cease operation for corrective actions, or their licenses of financial business be
revoked. Senior management, other executives in charge and individuals that are held immediately responsible for the misconduct shall
be disciplined by their institutions or superior ones in the way of severe demerit recording, or even more grave penalties until
being fired eventually. Staff of statistic units and related units in the People’s Bank of China that have any of the following behaviors
shall be disciplined by their working units or superior ones in the way of severe demerit recording or more grave penalties until
being fired eventually.
(1)
Overstate, conceal, counterfeit or distort financial statistic data by great value or in great proportion of the reportable value.
(2)
Overstate, conceal, counterfeit or distort financial statistic data more than once in one year.
(3)
Overstate, conceal, counterfeit or distort financial statistic data and refuse to take corrective actions when being asked to.
(4)
Overstate, conceal, counterfeit or distort financial statistic data resulting in severe consequences.
(5)
Other behaviors identified by regional branches, operation offices and branches in the capital cities of provinces of the People’s
Bank of China.
Article 40
As for those violating these rules by distorting financial statistic data or counterfeiting false figures in order to defraud of honorable
post_title, bonus or promotion, the institution that made that decision of award or its superior institution or supervisory bodies shall
revoke their honorable post_title, take back the bonus and cancel the promotion.
Article 41
When persons involved refuse to accept penalties issued in line with Article 38 , 39 of these rules, they may apply for administrative
appeal according to relevant laws and regulations. If they don’t agree on the appeal verdict, they may file a suit in the People’s
Court within 15 days after their receipt of administrative appeal verdict.
Article 42
When a crime is committed by violating these rules, the case shall be handed over to the judicial agencies and be prosecuted in accordance
with the law.
Chapter VIII Supplementary Provisions
Article 43
Regional branches, operation offices and branches in the capital cities of provinces of the People’s Bank of China and financial institutions
may formulate implementation provisions of these rules within their jurisdiction and file them with the head office of the People’s
Bank of China for record-keeping.
Article 44
The People’s Bank of China is responsible for the interpretation of these rules.
Article 45
These rules shall enter into force on December 15, 2002, and the “Administrative Rules for Financial Statistics” promulgated on December
3, 1995 are invalidated at the same time.
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