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State Food and Drug Administration
Order of the State Food and Drug Administration
No.16
The Measures for the Supervision over and Administration of Pharmaceutical Production, deliberated and adopted at the executive meeting
of the State Food and Drug Administration on May 28th 2004, is hereby promulgated, and shall be implemented as of the date of promulgation.
Zheng Xiaoyu, Director General of the State Food and Drug Administration
August 5th, 2004
Measures for the Supervision over and Administration of Pharmaceutical Production
Chapter I General Provisions
Article 1
With a view to strengthening the supervision over and administration of pharmaceutical production, the present Measures are formulated
pursuant to the Pharmaceutical Administration Law of the People’s Republic of China, Regulation on the Implementation of the Pharmaceutical
Administration Law of the People’s Republic of China (hereinafter referred to as the Pharmaceutical Administration Law, Regulation
on the Implementation of the Pharmaceutical Administration Law).
Article 2
The supervision over and administration of pharmaceutical production shall refer to the activities of the food and drug supervision
and administration departments who make examination, licensing, supervision and inspection on pharmaceutical production conditions
and process and other administrative activities.
Article 3
The State Food and Drug Administration shall be in charge of the work of supervision over and administration of pharmaceutical production
nationwide. The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities
directly under the Central Government are responsible for the supervision over and administration of pharmaceutical production within
their own administrative regions.
Chapter II Application for and Examination and Approval of Launching Pharmaceutical Production Enterprises
Article 4
When launching a pharmaceutical production enterprise, the following conditions shall also be satisfied in addition to meeting the
pharmaceutical industry development plan and industrial policies of the state:
1.
Having technicians in pharmacology, engineers and technicians and corresponding technical workers whose qualifications have been certified;
and the legal representative or responsible person of the enterprise and the person in charge of quality having no circumstances
as stipulated in Article 76 of the Pharmaceutical Administration Law;
2.
Having workshops, facilities and sanitation environment fitting in with pharmaceutical production;
3.
Having institutions, personnel that are able to make quality control of and inspection on the pharmaceuticals produced, and necessary
apparatus and equipment; and
4.
Having regulations that can ensure the pharmaceutical quality.
Where the relevant state laws and regulations have different provisions on the production of narcotic pharmaceuticals, psychotropic
pharmaceuticals, toxic pharmaceuticals for medical treatment use, radioactive pharmaceuticals, precursor chemicals of the pharmaceutical
category, etc., those provisions shall apply.
Article 5
Any applicant, who intends to launch a pharmaceutical production enterprise, shall file an application to the food and drug supervision
and administration department of the province, autonomous region, or municipality directly under the Central Government at his/its
locality, and submit the following documents:
1.
Basic information of the applicant and the pertinent certificate documents;
2.
Basic conditions of the enterprise to be launched, including the name of the enterprise to be launched, varieties of production, type
of medicament, equipment, technics and throughput; statements on the site of the enterprise, environment around the sites, and infrastructures,
etc., as well as the statements on investment scale and other conditions;
3.
Notice of pre-approval on the name of the enterprise to be launched issued by the department of industry and commerce administration,
production address and registration address, type of the enterprise, legal representative or responsible person of the enterprise;
4.
Plan of the organizations of the enterprise to be launched (indicating the functions of each sector and their correlations, responsible
person of each sector);
5.
Resumes, educational backgrounds and post_title certificates of the legal representative, responsible person of the enterprise to be launched
and the responsible person of each sector of the enterprise; registration form for the technicians of pharmacology and relevant professionals,
engineers and technicians, technical workers whose qualifications have been certified ipso jure with the indication of the sectors
and posts they are in; the proportion statement of the senior, medium and preliminary technicians;
6.
The map for the environment around the enterprise to be launched, general plane figure, storage plane figure, plane figure of quality
inspection place;
7.
Plan for the arrangement of production technics of the enterprise (including dressing room, water closet, passage for stream of people
and material circulation, and air brake, etc., and indicating the flowing direction of the people and materials and the grade of
air cleanliness factor), plan of the blow, return and ventilation of air cleansing system, and the plan for arrangement of technics
and equipment;
8.
The scope, type of medicament, varieties, quality standard and basis of the pharmaceuticals to be produced;
9.
The technical flow chart of the type of medicament and varieties of pharmaceuticals to be produced, with the major quality reference
points and items indicated;
10.
General situation on the validation of air cleansing system, water treatment system and the major equipment; conditions of checkout
of the production and inspection apparatus, instruments, and weighing apparatus;
11.
Lists of major production equipment and inspection apparatus; and
12.
Contents of documents on the production management and quality control of the enterprise to be launched.
The applicant shall be responsible for the truthfulness of all the contents of the application documents.
Article 6
Where a pharmaceutical production enterprise divides part of the production workshops and forms an independent pharmaceutical production
enterprise, it shall handle the Pharmaceutical Production License in conformity with the provisions of Articles 4 and 5 of the present
Measures.
Article 7
The food and drug supervision and administration departments of the provinces, autonomous regions, and municipalities directly under
the Central Government shall, after receiving the application, make handling in accordance with the following circumstances respectively:
1.
Where the matters applied for do not fall within the scope of functions and powers of the corresponding department ipso jure, the
department shall make decision on not accepting it, and notify the applicant to apply to the relevant administrative department;
2.
Where the application documents have mistakes that can be corrected on the spot, the applicant shall be allowed to correct on the
spot;
3.
Where the application documents are incomplete or do not comply with the requirements for the examination on the format, the department
shall issue the Notice on Supplementing and Correcting the Documents to the applicant on the spot or within 5 workdays, and notify
the applicant of all the contents to be supplemented and corrected. If it fails to notify within the time limit, the date of acceptance
shall be the date when the department has received the application documents; and
4.
If the application documents are complete and comply with the examination requirements, or the applicant has submitted all the supplementary
documents as required, the application shall be accepted.
Where any food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly
under the Central Government accepts or does not accept the application for the establishment of the pharmaceutical production enterprise,
it shall issue a Notice of Acceptance or Notice of Not Acceptance, which is sealed by the special seal of the corresponding department
and indicated with the date thereof.
Article 8
The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall make a decision within 30 workdays after the application is accepted.
If the application fulfills the requirements after examination, the department shall grant approval, and verify and issue the Pharmaceutical
Production License within 10 workdays as of the date when the decision on written approval has been made. If the application does
not fulfill the requirements, the department shall make a written decision on not approval, and explain the reasons, meanwhile notify
the applicant of his right to apply for administrative reconsideration or institute an administrative proceeding ipso jure.
Article 9
In case of launching a new pharmaceutical production enterprise, or a pharmaceutical production enterprise builds a new pharmaceutical
production workshop or newly adds production form of prepared pharmaceuticals, the enterprise shall file an application for certification
of Pharmaceutical Production Quality Control Criterions to the corresponding food and drug supervision and administration department
in accordance with the provisions of the State Food and Drug Administration within 30 days as of the date of obtaining pharmaceutical
production certificate documents or as of the date when it is approved to make production officially.
Article 10
The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall make a public notice on the website or at the office place of the administrative department on the conditions,
procedures and time limit for applying for the Pharmaceutical Production License, the whole documents to be submitted and the model
text of the application letter, etc.
The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall open the relevant information on the issuance of Pharmaceutical Production License. The general public
shall be enpost_titled to consult.
Article 11
The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall make an announcement on the process and result of examination and approval when making examination on
the application of the pharmaceutical production enterprise. The applicant and the interested parties may submit written opinions
to make statements and defense on the matters directly pertaining to their major interests.
Article 12
Where the application for the establishment of any pharmaceutical production enterprise directly involves major interest relations
between the applicant and others, the food and drug supervision and administration department of the provinces, autonomous regions,
and municipalities directly under the Central Government shall notify the applicant and the interested parties that they may enjoy
the right to apply for hearing pursuant to laws and regulations and other provisions of State Food and Drug Administration. When
making examination on the application for establishment of pharmaceutical production enterprises, the food and drug supervision and
administration department of the provinces, autonomous regions, and municipalities directly under the Central Government shall make
an announcement to the society on the major licensing matters concerning the public interests, and hold hearings.
Chapter III Administration on Pharmaceutical Production License
Article 13
The Pharmaceutical Production License shall have the original copy and the duplicate, the duplicate shall possess the same legal effect
as the original one, and the period of validity shall be five years.
The Pharmaceutical Production License shall be printed exclusively by the State Food and Drug Administration.
Article 14
The Pharmaceutical Production License shall bear the serial number of the License, name of the enterprise, legal representative, enterprise
type, registration address, production address, production scope, license issuing organ, date for license issuance, period of validity,
and other items, etc.. Among them the licensing matters that are subject to the approval of the food and drug supervision and administration
department shall be: responsible person of the enterprise, scope of production, and production address.
Such items as the name of the enterprise, legal representative, registration address, and enterprise type shall conform to the relevant
contents as specified in the business license issued by the administrative department for industry and commerce.The name of an enterprise
shall follow the principle of classified administration of pharmaceutical production enterprises. The production address shall be
filled in according to the actual pharmaceutical production address. The serial number of the License and the production scope shall
be filled in according to the methods and classes as stipulated by the State Food and Drug Administration.
Article 15
The alteration of Pharmaceutical Production License shall cover the alteration of the licensing matters and alteration of registration
matters.
The alteration of licensing matters shall refer to the alteration of the responsible person of the enterprise, production scope and
production address.
The alteration of the registration matters shall refer to the alteration of the matters as listed in paragraph 2 of Article 14 of
the present Measures.
Article 16
Where a pharmaceutical production enterprise alters the licensing matters in the Pharmaceutical Production License, it shall file
an alteration application to the original license issuing organ 30 days prior to the occurrence of alteration of the original licensing
matters. No enterprise may alter the licensing matters at will without authorization.
The original license-issuing organ shall make a decision on whether to approve the alteration or not within 15 workdays as of the
date when the application for alteration of an enterprise is received. If it does not grant the alteration, it shall explain the
reason in writing, and notify the applicant of his/its rights to apply for administrative reconsideration or to institute an administrative
proceeding ipso jure.
In case of alteration of production scope or production address, a pharmaceutical production enterprise shall submit the relevant
documents pertaining to the contents of alteration as stipulated in Article 5 of the present Measures, and report to the food and
drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government
at its locality for examination and determination.
After a pharmaceutical production enterprise has gone through formalities for alteration of licensing matters in the Pharmaceutical
Production License, it shall handle formalities for the alteration of the enterprise registration to the administrative department
for industry and commerce in time.
Article 17
Where a pharmaceutical production enterprise alters the registration matters in the Pharmaceutical Production License, it shall apply
for alteration registration on Pharmaceutical Production License to the original license issuing organ within 30 days after the alteration
is approved by the administrative department for industry and commerce.
Article 18
After the alteration of the Pharmaceutical Production License, the original license issuing organ shall record the contents and time
of alteration on the duplicate of the Pharmaceutical Production License, and reissue the original copy of the Pharmaceutical Production
License in accordance with the contents altered, and take back the former original copy of the Pharmaceutical Production License.
The period of validity of the Pharmaceutical Production License shall remain unchanged.
Article 19
Where the period of validity of the Pharmaceutical Production License expires and it is necessary to continue to produce pharmaceuticals,
the pharmaceutical production enterprise shall file an application for changing of the Pharmaceutical Production License to the original
license issuing organ 6 months prior to the expiry of the period of validity.
The original license issuing organ shall, in combination with the situations of the enterprises on their observance of laws and regulations,
and the Pharmaceutical Production Quality Control Criterions and operation of quality system, make examination on the procedures
and requirements for the establishment of pharmaceutical production enterprises as prescribed by the present Measures, and make decision
on whether to grant the change of the Pharmaceutical Production License or not before the expiry of the period of validity. In case
the requirements are fulfilled and the change of license is granted, the original license shall be taken back, and a new license
shall be issued. If the requirements are not fulfilled, the organ shall make a decision in writing on not granting the change of
license, and explain the reason, meanwhile, notify the applicant of his/its rights to file application for administrative reconsideration
or constitute an administrative proceeding ipso jure. In case the organ fails to make decision within the prescribed time limit,
it shall be deemed as agreeing to the change of license, and go through the corresponding due formalities.
Article 20
Where a pharmaceutical production enterprise terminates pharmaceutical production or is closed, the original license issuing organ
shall revoke its Pharmaceutical Production License, and notify the administrative department for industry and commerce.
Article 21
Where the Pharmaceutical Production License is lost, the pharmaceutical production enterprise shall file an application to the original
license issuing organ for reissue, and publish a lost license statement in the media designated by the original license issuing organ,
who shall then reissue the Pharmaceutical Production License within 10 workdays in accordance with the original approval matters
at the date when the enterprise has published the loss license statement for one full month.
Article 22
No entity or individual may forge, alter, sell or purchase, lease, or lend Pharmaceutical Production License.
Article 23
The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall report to and put on archives the issuance, change, alteration, reissue, revocation, withdrawal and
capture, writing off of the Pharmaceutical Production License to the State Food and Drug Administration within 20 workdays after
completing the work for the handling them.
Chapter IV Administration on Production of Pharmaceuticals by Entrustment
Article 24
The entrusting party of pharmaceutical production by entrustment shall be the pharmaceutical production enterprise that has obtained
the registered number of approval for the pharmaceutical.
Article 25
The entrusted party of pharmaceutical production by entrustment shall be the pharmaceutical production enterprise that has the certification
certificate of Pharmaceutical Production Quality Control Criterions corresponding with the production conditions of such pharmaceuticals.
Article 26
The entrusting party shall be responsible for the quality and sale of the pharmaceuticals produced through entrustment. The entrusting
party shall make scrutiny on the production conditions, production technical level and quality control status of the entrusted party,
and shall provide the technology and quality documents to the entrusted party on pharmaceuticals produced through entrustment, and
make guidance to and supervision over the whole process of production.
The entrusted party shall make production in accordance with the Pharmaceutical Production Quality Control Criterions and keep all
the documents and records on the production through entrustment as required.
Article 27
The two parties of pharmaceutical production through entrustment shall sign a contract. The contents of the contract shall include
the rights and obligations of both parties, and stipulate the rights and obligations of the two parties in the technology, quality
control and other aspects of the pharmaceutical production through entrustment, and shall abide by the relevant pharmaceutical administrative
laws and regulations of the state.
Article 28
The application for the production of injections, biological products (with an exception of bacterin products, and blood products)
and for the trans-province, trans-autonomous region, and trans-municipality pharmaceuticals production through entrustment shall
be accepted and subject to the examination and approval of the State Food and Drug Administration.
The bacterin products, blood products and other pharmaceuticals as provided for by the State Food and Drug Administration may not
be produced through entrustment.
The production of narcotic pharmaceuticals, psychotropic pharmaceuticals, toxic pharmaceuticals for medical treatment use, radioactive
pharmaceuticals, precursor chemicals of the pharmaceutical category through entrustment shall be conducted according to the relevant
laws and regulations.
Article 29
The application for the production through entrustment of other pharmaceuticals which are not included in Article 28 of the present
Measures shall be accepted by and subject to the examination and approval of the food and drug supervision and administrative department
of the provinces, autonomous regions, and municipalities directly under the Central Government at the locality of both parties of
the production through entrustment.
Article 30
Where a pharmaceutical is produced through entrustment, the entrusting party shall file an application to the State Food and Drug
Administration or the food and drug supervision and administration department of the provinces, autonomous regions, or municipalities
directly under the Central Government, and submit the application documents as stipulated in Article 34 of the present Measures.
The food and drug supervision and administration department shall accept it by referring to the provisions of Article 7 of the present
Measures.
Article 31
The food and drug supervision and administration department that accepts the application shall, within 20 workdays as of the date
of accepting the application, make examination on the application for pharmaceutical production through entrustment in conformity
with the conditions as prescribed by the present Chapter, and make decisions on it. In case it cannot make decisions within 20 workdays,
it may extend 10 workdays upon the approval of the responsible person of its own department, and notify the entrusting party of the
reasons for the extension.
Where, after examination, the application fulfills the requirements, an approval shall be granted, and the entrusting party shall
be issued the Document of Approval for Pharmaceutical Production through Entrustment within 10 workdays as of the date when the decision
on written approval has been made. In case it does not fulfill the requirements, the department shall notify the entrusting party
in writing and state the reason, and meanwhile notify the entrusting party of its right to apply for administrative reconsideration
or to institute an administrative proceeding ipso jure.
Article 32
The period of validity of the Documents of Approval for Pharmaceutical Production through Entrustment may not exceed two years, and
may not exceed the effective time as prescribed by the certificate documents of approval of the pharmaceutical.
Article 33
Where the period of validity of the Document of Approval of Pharmaceutical Production through Entrustment expires and it is necessary
to continue to produce pharmaceuticals through entrustment, the entrusting party shall submit the relevant documents in conformity
with the provisions of Article 34 of the present Measures, and go through formalities for extension.
Where the contract of production through entrustment terminates, the entrusting party shall go through the formalities for write-off
of the Document of Approval for Pharmaceutical Production through Entrustment in time.
Article 34
Items of application documents for pharmaceutical production through entrustment:
1.
The photocopies of the Pharmaceutical Production License and the business license of the entrusting party and the entrusted party;
2.
Photocopy of the certification certificate of the Pharmaceutical Production Quality Control Criterions of the entrusted party;
3.
The conditions concerning the entrusting party’s examination on the production and quality guaranty conditions of the entrusted party;
4.
Photocopy of the certificate documents of approval for pharmaceutical production through entrustment with the attachments of quality
standard, production technics, and the actual samples of packaging, label, and the instructions;
5.
The pattern of the packaging, label, and the instructions and the color labels to be adopted for the pharmaceutical produced through
entrustment;
6.
Contract of production through entrustment;
7.
The product testing report of three consecutive batches of the products issued by the pharmaceutical testing offices at the level
of province at the locality of the entrusted party. Where of producing biological products through entrustment, the three batches
of samples shall be taken out and sealed up for keeping by the pharmaceutical testing offices at the level of province at the locality
of the entrusted party. And the National Institute for the Control of Pharmaceutical and Biological Products shall be responsible
for the testing and issue the testing report;
8.
The food and drug supervision and administration department of the province, autonomous region, and municipality directly under the
Central Government at the locality of the entrusted party shall put forward opinions on the enterprise technicians, workshops, facilities,
equipment and other production conditions and abilities, and the examination on the quality inspection organs, testing equipment
and other quality guaranty systems.
The items of application documents as required for the application for extension of pharmaceutical production through entrustment:
1.
Photocopies of the Pharmaceutical Production License and business license of the entrusting party and the entrusted party;
2.
Photocopy of the certification certificate of the Pharmaceutical Production Quality Control Criterions of the entrusted party;
3.
Photocopy of the Document of Approval for Pharmaceutical Production through Entrustment approved in the last time;
4.
Summaries of the periods, production and quality conditions of the production through entrustment of the last time; and
5.
Certificate documents on the changes compared with the Document of Approval for Pharmaceutical Production through Entrustment of the
last time.
Article 35
The national pharmaceutical quality standard shall be carried out for the quality standards for pharmaceuticals produced through entrustment,
and the prescriptions, production technics, packaging specifications, labels, instructions for the use, registered number of approval,
etc., shall be in conformity with the contents approved originally. The name, registration address of the entrusting enterprise and
the name and production address of the entrusted enterprise shall be indicated in the packaging, labels, and instructions of the
pharmaceutical produced through entrustment.
Article 36
The food and drug supervision and administration department shall refer to the relevant provisions of Articles 10 through 12 of Chapter
II of the present Measures when making examination on the application for pharmaceutical production through entrustment.
Article 37
Where any pharmaceutical production enterprise accepts the entrustment of any overseas pharmaceutical factory to process pharmaceuticals
within the territory of China, it shall put it on archives at the food and drug supervision and administration department of the
province, autonomous region, and municipality directly under the Central Government at its locality within 30 days after signing
the contract of production through entrustment. The pharmaceuticals processed may not be sold and used in any forms within the territory
of China.
Article 38
The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall report the conditions for the approval and archival filing of pharmaceutical production through entrustment
to State Food and Drug Administration.
Chapter V Supervision and Inspection
Article 39
The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under
the Central Government shall be responsible for the supervision over and inspection on pharmaceutical production enterprises within
their own administrative regions, and shall establish an operation mechanism and administration system for the implementation of
supervision and inspection, clarify the functions of supervision over and inspection on food and drug supervision and administration
organs at the level of cities divided into districts and the food and drug supervision and administration organs at the county level.
State Food and Drug Administration may make supervision over and inspection on pharmaceutical production enterprises directly, and
make supervision over and selective examination on the supervision and inspection work of the food and drug supervision and administration
department of the provinces, autonomous regions, and municipalities directly under the Central Government and on the implementation
of the Pharmaceutical Production Quality Control Criterions on the production enterprises that have passed the certification.
Article 40
The major contents of supervision and inspection shall include: conditions concerning the implementation of the relevant laws, regulations
and the implementation of the Pharmaceutical Production Quality Control Criterions. Supervision and inspection includes the on-the-spot
inspection on the change of Pharmaceutical Production License, the follow-up inspection on Pharmaceutical Production Quality Control
Criterions and ordinary supervision and inspection, etc..
Article 41
The food and drug supervision and administration departments at all levels shall formulate inspection plans when organizing supervision
and inspection, clarify inspection standards, and record on-site inspection conditions according to the facts. The ins
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the Office of the State Administration of Foreign Experts Affairs, the Consular Department of the Ministry of Foreign Affairs
Notice of the Office of the State Administration of Foreign Experts Affairs and the Consular Department of the Ministry of Foreign
Affairs on the Use and Administration of the Permit for Foreign Experts Working in China
No.105 [2004] of the Office of the State Administration of Foreign Experts Affairs
The foreign affairs offices and administrations of foreign experts affairs of the people’s governments of all provinces, autonomous
regions and municipalities directly under the Central Government, all the ministries and commissions of the State Council, organs
directly under the State Council, institutions, and international cooperative departments (foreign affairs departments) of special
parent companies:
For the purpose of implementing the Administrative License Law of the People’s Republic of China and the Decision of the State Council
on Establishing Administrative License for Administrative Examination and Approval Projects That Really Need to Be Reserved (Order
No. 412 of the State Council), and strengthening management on the work of our country for introduction of foreign talents and foreign
experts through specialized departments, we decide to adopt the measures on the Permit for Foreign Experts Working in China when
foreign experts apply for vocational (Z) visa on working in China. And relevant issues concerned are noticed hereby:
I.
All the foreign experts, who are invited to work in China in accordance with the relevant provisions of the Central Committee of the
Communist Party of China and the State Council on introducing intellects and strengthening foreign experts administration, shall
be exempted from obtaining employment licenses and employment permits. From October 1st, 2004, any of the aforesaid foreign experts,
who needs to draw a vocational visa, shall apply for the vocational (Z) visa at Chinese embassy or consulate in the foreign country
upon the strength of the Permit for Foreign Experts Working in China (For the format, see Attachment I) issued by the State Administration
of Foreign Experts Affairs, the letter of notice of visa issued by the authorized entity and the effective passport of his domestic
country or other certificates that can substitute the passport.
II.
Pursuant to the provisions of Order No.412 of the State Council, the State Administration of Foreign Experts Affairs and the specialized
departments for managing foreign experts affairs under the people’s governments at the provincial level shall issue the Permit for
Foreign Experts Working in China. The Chinese embassies or consulates in foreign countries shall keep the originals of the Permits
for Foreign Experts Working in China after checking and issuing vocational (Z) visas for foreign experts.
III.
The specialized departments of all people’s governments at the provincial level for managing foreign experts affairs shall strictly
administer and issue the Permit for Foreign Experts Working in China, and shall not issue work permits for entities and foreign personnel
that fall short of the invitation requirements. When issuing work permits, the said departments shall well do the work for classified
registration and statistic.
IV.
No specialized department of any of the people’s governments at the provincial level for managing foreign experts affairs may charge
fees when issuing Permits for Foreign Experts Working in China, nor shall it transfer the power for issuing permits to a department
at lower level or transfer it to the subordinate institution for handling. The State Administration of Foreign Experts Affairs shall
make regular examinations on the requirements for issuing work permits.
V.
The Permit For Foreign Experts Working in China shall be printed and distributed by the State Administration of Foreign Experts Affairs
uniformly, and shall be numbered by the issuing entities.
VI.
Any problem encountered in the implementation of the Permit for Foreign Experts Working in China, please be reported to the office
of the State Administration of Foreign Experts Affairs in time.
VII.
The original Confirmation Document for Inviting Foreign Experts shall be stopped using from October 1st, 2004, and the Notice of the
Office of the State Administration of Foreign Experts Affairs and the Consular Department of the Ministry of Foreign Affairs on the
Use and Administration of the Confirmation Document for Inviting Foreign Experts ([1996] No.16 of the Office of the State Administration
of Foreign Experts Affairs) shall be abolished simultaneously.
Attachment:
1.
the Format of the Permit for Foreign Experts Working in China
2.
the List of the Specialized Departments of the People’s Governments at the Provincial Level for Managing Foreign Experts Affairs
the Office of the State Administration of Foreign Experts Affairs
the Consular Department of the Ministry of Foreign Affairs
August 8, 2004 htm/e03947.htm Attachment I
Attachment I:
the Sequence Number of Printing:
the Counterfoil of the Permit for Foreign Experts Working in China (This page shall be kept by the Permit handling department.)
Type: Economy and Technology ( ) Culture and Education ( )
Serial Number: _________
Embassy or Consulate in ________________:
Name (Foreign Name): Mr./ Mrs. _________________ (Number of the Passport: ____________) is engaged to work in ___________________in
China (From Month ____Date ____, Year _____ to Month ____Date ____, Year _____), please help issue a vocational (Z) visa.
The relatives following him /her are _________ persons altogether.
Issuer: ____________
Month ____Date ____,Year _____
the Sequence Number of Printing:
the Counterfoil of the Permit for Foreign Experts Working in China (This page shall be kept by the applicant)
Type: Economy and Technology ( ) Culture and Education ( )
Serial Number: _________
Embassy or Consulate in ___________________:
Name (Foreign Name): Mr./ Mrs. _________________ (Number of the Passport: ____________) is engaged to work in ___________________in
China (From Month ____Date ____, Year _____ to Month ____Date ____, Year_____), please help issue a vocational (Z) visa.
The relatives following him /her are _________ persons altogether.
Issuer: ____________
Month ____Date ____, Year_____
the Sequence Number of Printing:
Permit of the Peoples Republic of China for Foreign Experts Working in China
The State Administration Of Foreign Experts Affairs, P.R.C. requests that foreign expert presents this Working Permitalong with the invitation letter to have his/her Z visa processed at the nearest Chinese Embassy or Consulate.
Type: Economic and Technology ( ) Cultural and Education ( ) Serial Number: _________
Signing and issuing department (with seal):___________________ Issuer: __________________
Signing and issuing date: Month ______ Date ______, Year _______
Embassy or Consulate in ____________________
Name (Foreign Name): Mr./ Mrs. _________________ (Number of the Passport: ____________) is engaged to work in ___________________in
China (From Month ____Date ____, Year _____ to Month ____Date ____, Year _____), please help issue a vocational (Z) visa.
The relatives following him /her are _________ persons altogether.
Name of his/her spouse: ______________________
Name of his/her children: _____________________
(The period of validity of the permit shall be six months)
the State Administration of Foreign Experts Affairs.(with seal)
Attachment II.:
the List of the Specialized Departments of the Peoples Governments at the Provincial Level for Managing Foreign Experts Affairs
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the Peoples Governments at the Province Level
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the List of the Specialized Departments for Managing Foreign Experts Affairs
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Provinces (Districts or Cities)
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Specialized Departments for Managing Foreign Experts Affairs
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Beijing Municipality
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Beijing Administration of Foreign Experts Affairs (Office for the Introduction of Oversea Intellects)
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Tianjin Municipality
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Tianjin Administration of Foreign Experts Affairs (Office for the Introduction of Overseas Intellects)
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Shanghai Municipality
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Shanghai Administration of Foreign Experts Affairs
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Chongqing Municipality
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Chongqing Administration of Foreign Experts Affairs
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Hebei Province
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Hebei Provincial Administration of Foreign Experts Affairs
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Shanxi Province
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Shanxi Provincial Administration of Foreign Experts Affairs
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Inner Mongolia Autonomous Region
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Administration of Foreign Experts Affairs of Inner Mongolia Autonomous Region
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Liaoning Province
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Liaoning Provincial Administration of Foreign Experts Affairs
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Jilin Province
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Jilin Provincial Administration of Foreign Experts Affairs
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Ministry of Commerce
2004-08-09
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China Insurance Regulatory Commission
Order of China Insurance Regulatory Commission
No.9
The Interim Measures for the Control of Overseas Use of Insurance-related Foreign Exchange Funds as formulated jointly by China Insurance
Regulatory Commission and the People’s Bank of China are hereby promulgated and shall be implemented as of the date of promulgation.
Wu Dingfu, Chairman of China Insurance Regulatory Commission
Zhou Xiaochuan, President of the People’s Bank of China
August 9th, 2004
Interim Measures for the Control of Overseas Use of Insurance-related Foreign Exchange Funds
Chapter I General Provisions
Article 1
With a view to strengthening the control of overseas use of insurance-related funds, preventing risks and safeguarding the interests
of the insured, these Measures are formulated in conformity with the Insurance Law of the People’s Republic of China, Regulations
of the People’s Republic of China on Foreign Exchange Control and other pertinent laws and regulations.
Article 2
An insurance company mentioned in the present Measures refers to a Chinese capital insurance company, foreign capital insurance company,
Chinese-foreign joint venture insurance company or a branch of any foreign insurance company, set up with the approval of China Insurance
Regulatory Commission (hereinafter referred to as CIRC) and registered according to the law in the People’s Republic of China.
The insurance-related foreign exchange fund as mentioned in the present Measures refers to the sum of capital, public reserve fund,
undistributed profits, various reserves and guarantee deposits received in foreign currencies of an insurance company.
Article 3
In the overseas use of its foreign exchange fund, the insurance company shall follow the principles of security, liquidity and profitability
and be prudent in making investment and shall operate independently at its own risk.
Article 4
In the overseas use of its foreign exchange fund, the insurance company shall accord with the present Measures and other laws and
regulations concerning insurance and foreign exchange control, as well as the pertinent foreign laws and regulations.
Article 5
CIRC and the State Administration of Foreign Exchange (hereinafter referred to as SAFE) shall carry out supervision over and control
of the overseas use of insurance-related foreign exchange funds.
Chapter II Qualification Requirements
Article 6
An insurance company engaging in overseas use of its foreign exchange fund shall fulfill the following requirements:
(1)
possessing a license for engaging in foreign exchange;
(2)
its total assets at the end of the previous year being not less than RMB5 billion yuan;
(3)
its foreign exchange fund at the end of the previous year being not less than US$15 million or its equivalent in other freely convertible
currencies;
(4)
its solvency margin conforming to the pertinent provisions of CIRC;
(5)
possessing a professional fund use department or a pertinent insurance asset management company;
(6)
its internal management system and risk control system conforming to the provisions of the Guidelines for Risk Control in the Use
of Insurance Funds;
(7)
the number of its professional and managerial personnel with at least two years of experience in overseas investment conforming to
the pertinent provisions; and
(8)
other requirements as may be provided by CIRC and SAFE.
Article 7
In terms of the overseas use of its foreign exchange fund, the insurance company shall, within the amount of its foreign exchange
balance at the previous yearend, apply to SAFE for foreign exchange remittance and payment for investment outside China by submitting
the following documents and materials in triplicate:
(1)
a written application containing at least the background of the applicant, the amount of foreign exchange applied for to be paid for
investment and the investment plan;
(2)
its financial statements and balance sheet in foreign currencies at the previous yearend as audited by an accounting firm;
(3)
reports on its solvency positions at the end of last year and at the end of last quarter as audited by an accounting firm and notes
to such reports;
(4)
a brief of its internal professional fund use department or of pertinent insurance asset management company;
(5)
its internal management system and risk control system;
(6)
resumes of its professionals engaging in overseas investment;
(7)
materials concerning its domestic custodian and the draft custody agreement;
(8)
materials concerning its external trustee and the draft asset management entrustment agreement, if it has an external trustee; and
(9)
other materials as prescribed by CIRC and SAFE.The SAFE shall make a decision as whether or not to approve the application within
20 days as of the receipt of all necessary application documents. In the case of approval, the amount of foreign exchange payment
for investment as approved shall be notified in writing to the applicant; in the case of disapproval, such disapproval shall be notified
in writing to the applicant with reasons stated. A copy of such decision for either approval or disapproval shall also be sent to
CIRC.
Article 8
When its foreign exchange fund increases due to its capital increase or shares expansion or overseas listing, the insurance company
may apply to the SAFE for an increase of the specified amount of foreign exchange payment for investment for the current year by
submitting to the SAFE the pertinent documents and materials.The SAFE shall make a decision in conformity with Article 7 of the
present Measures.
Chapter III Investment Scope and Proportion
Article 9
The overseas use of insurance-related foreign exchange funds shall be limited to the following investment types and instruments:
(1)
bank deposits;
(2)
bonds of a foreign government, international financial organization or foreign company;
(3)
bonds issued outside China by the Chinese government or a Chinese enterprise;
(4)
money market derivatives, such as bank’s bills and large negotiable certificates of deposit; and
(5)
other investment types and instruments within the scope specified by the State Council.
The bank as referred to in item (1) of the preceding paragraph means either an external branch of a Chinese capital commercial
bank or a foreign bank with at least grade A or its equivalent of long-term credit as assessed by an internationally accepted rating
agency for the past three years.
The bond as referred to in item (2) of the preceding paragraph means that of at least grade A or its equivalent as assessed by
an internationally accepted rating agency.
The money market derivatives as referred to in item (4) of the preceding paragraph mean money market fixed income derivatives
of at least grade AAA or its equivalent as assessed by an internationally accepted rating agency.
Article 10
Any overseas use of insurance-related foreign exchange fund shall accord with the proportions as follows:
(1)
the total amount of the insurance company that may be used in investment may not be more than 80% of its foreign exchange balance
at the end of last year or, in the case of any circumstances under Article 8 herein, it may not be more than 80% of the sum of its
foreign exchange balance at the end of last year and the increased fund;
(2)
the actual total amount of investment of the insurance company may not be more than the amount of foreign exchange payment for investment
as approved by the SAFE;
(3)
the insurance company’s deposit in one bank may not be more than 30% of the amount of foreign exchange payment for investment as approved
by the SAFE, however, the balance in the account for settlement of overseas use of foreign exchange fund shall not be subject to
this limit;
(4)
the balance of all bonds of grade A of credit that the insurance company invested in, apart from those issued overseas by the Chinese
government or a Chinese enterprise, as calculated at their cost prices, may not be more than 30% of the amount of foreign exchange
payment for investment as approved by the SAFE;
(5)
the balance of all bonds below grade AA of credit that the insurance company invested in, apart from those issued overseas by the
Chinese government or a Chinese enterprise, as calculated at their cost prices, may not be more than 70% of the amount of foreign
exchange payment for investment as approved by the SAFE;
(6)
the balance of bonds issued by one company or enterprise, which the insurance company invested in, as calculated at their cost prices,
may not be more than 10% of the amount of foreign exchange payment for investment as approved by the SAFE; and
(7)
the balance of bonds issued overseas by the Chinese government or Chinese enterprises, which the insurance company invested in, as
calculated at their cost prices, may not be more than the amount of foreign exchange payment for investment as approved by the SAFE.
Chapter IV Investment Management
Article 11
In terms of overseas use of its insurance-related foreign exchange fund, the head office of the insurance company shall carry out
a unified strategic allocation of assets, and the internal professional fund use department or the pertinent insurance asset management
company shall be in charge of the operation and management.
No branch of an insurance company may undertake any overseas use of foreign exchange fund.
Article 12
Any overseas use of insurance-related foreign exchange fund must be made in conformity with the Guideline for Risk Control in the
Use of Insurance Funds and under a well-established risk control system.
The risk control system shall at least contain the investment decision-making procedure, investment authorization system, research
and reporting system, and risk assessment and performance appraisal index systems.
Article 13
In the overseas use of its foreign exchange fund, an insurance company may entrust the investment management to an external professional
investment institution satisfying the requirements prescribed in Article 14 herein.
Article 14
The external professional investment institution to which an insurance company entrust its investment management must fulfill the
following requirements:
(1)
being allowed to engage in asset management business according to the law of the country or district concerned;
(2)
its risk control index conforming to the pertinent provisions of the regulatory authority of the country or district concerned;
(3)
both its paid-in capital and net assets being not less than US$60 million respectively or its equivalent in other freely convertible
currencies, and the assets under its management being not less than US$50 billion or its equivalent in other freely convertible currencies;
(4)
possessing a sound corporate governance structure and well-established internal management system and risk control mechanism, and
having no record of any major illegal or irregular act in the country or district concerned in the past three years;
(5)
having at least ten years of experience in international asset management business, and having professional investment personnel of
a corresponding number;
(6)
committing in writing to a promise that, if necessary, it shall, at the request of CIRC, provide the exact state of transactions relating
to the overseas use of insurance-related foreign exchange fund;
(7)
the country or district concerned having a well-defined financial regulatory system, and there being a memorandum of understanding
concerning regulatory cooperation and effective regulatory cooperation relations between financial regulatory authority of the country
or district concerned and the Chinese financial regulatory authority; and
(8)
other requirements for prudence as prescribed by CIRC.The provisions concerning professional investment institutions established overseas
by domestic financial institutions, to which the management of insurance-related foreign exchange fund is entrusted, shall be separately
formulated by CIRC.
Article 15
When an insurance company entrusts its investment management to an external trustee, its internal professional fund use department
or related insurance asset management company shall be in charge of the delegation matters, and appraise the risk level of the trusted
assets, investment performance and management ability of the external trustee.
When selecting an external trustee for the management of insurance-related foreign exchange fund, the risk of management shall be
fully taken into consideration, and the foreign exchange fund under trusteeship management shall be decentralized properly.
Article 16
In the overseas use of its insurance-related foreign exchange fund, an insurance company shall lay stress on that the use matches
its liabilities in foreign exchange in terms of term structures and currency structures.
When undertaking overseas use of its insurance-related foreign exchange fund, the insurance company shall give priority to the bonds
issued overseas by the Chinese government and Chinese enterprises.
Chapter V Asset Custody
Article 17
In the overseas use of its foreign exchange fund, an insurance company shall entrust the custody of all its assets used overseas to
a domestic commercial bank.
The commercial bank as in the preceding paragraph means any Chinese capital bank, branch of a foreign bank, Chinese-foreign joint
venture bank or foreign capital bank in the territory of China.
Article 18
A commercial bank to be a domestic custodian of an insurance company shall fulfill the following requirements:
(1)
having been a designated foreign exchange bank for more than three years;
(2)
its paid-in capital being not less than RMB8 billion yuan, of which, there must be foreign exchange capital in freely convertible
currencies at the value of RMB1 billion yuan for a Chinese capital bank; the paid-in capital of the branch of a foreign bank shall
be calculated in light of its head office;
(3)
having obtained qualifications for domestic securities investment fund custody business;
(4)
having a sound corporate governance structure and well-established internal management system and risk control system;
(5)
having a special custody department and personnel of corresponding number who are familiar with global custody business;
(6)
having a safe and efficient clearing and settlement system and emergency mechanism;
(7)
having no record of any major illegal or irregular act, and neither the head office nor the branch having been heavily punished by
the regulatory authority of the country or district concerned, in the past three years; and
(8)
other requirements as prescribed by CIRC and SAFE.
The branch of a foreign bank shall not be subject to item (3) of the preceding paragraph, on condition that its head office has a
custody scale of at least US$100 billion.
Article 19
The domestic custodian of an insurance company shall perform the following obligations:
(1)
to manage the foreign exchange fund and securities entrusted by the insurance company;
(2)
to open a domestic custody account, external foreign exchange use settlement account and securities custody account in respect of
insurance-related foreign exchange fund;
(3)
to conduct outward and inward remittance of foreign exchange fund and the pertinent exchange formalities;
(4)
to supervise the overseas investment operation by the insurance company, insurance asset management company and external trustee,
jointly with the external custody agent;
(5)
to promptly notify the insurance company of any illegal or irregular investment directions whenever they find any;
(6)
to supervise the external custody agent and make sure that the insurance-related foreign exchange fund is in safe custody;
(7)
to keep for at least 15 years the records, vouchers and other pertinent materials of inward and outward remittance and transactions
of foreign exchange fund and transactions of securities;
(8)
to conduct the declarations for statistics of the international balance of payment in conformity with such provisions as the Measures
for Declarations for Statistics of International Balance of Payment, Operation Rules for Financial Institutions’ Handling Declarations
for Statistics of International Balance of Payment, and Operation Rules for Financial Institutions’ Handling Declarations of External
Asset Balance and Profit and Loss;
(9)
to assist CIRC and SAFE in inspecting the overseas use of insurance-related foreign exchange funds; and
(10)
other obligations as prescribed by CIRC and SAFE.
Article 20
The domestic custodian of an insurance company shall submit the pertinent reports pursuant to the following provisions:
(1)
a report on the opening of the insurance company’s domestic custody account, external foreign exchange use settlement account and
securities custody account shall be made to CIRC and SAFE within five days as of the day when they are opened;
(2)
a report on the insurance company’s outward remittance of principal and inward remittance of principal and earnings shall be made
to SAFE with a copy thereof to CIRC within two days as of the day of remittance;
(3)
a report on the receipt and payment in the domestic custody account of the insurance company shall be made to CIRC and SAFE within
five days from the end of each month;
(4)
a statement of the overseas use of insurance-related foreign exchange fund shall be submitted to CIRC and SAFE within ten days as
of the end of each quarter;
(5)
a statement of the overseas use of foreign exchange fund of the insurance company for the last year shall be submitted to CIRC and
SAFE within one month as of the end of each fiscal year;
(6)
it shall promptly report to CIRC and SAFE any illegal or irregular investment directions of the insurance company, insurance asset
management company or external trustee whenever it finds them; and
(7)
it shall report other matters to CIRC and SAFE as prescribed by them.
Article 21
After receiving the approval document from SAFE for the amount of foreign exchange payment for investment, an insurance company shall
conclude a custody agreement with the domestic custodian by producing such approval document, and open a domestic custody account.
Article 22
The insurance company shall submit the following documents to CIRC and SAFE within five days as of the opening of its domestic custody
account:
(1)
a copy of the custody agreement; and
(2)
a written commitment of the domestic custodian that it shall, pursuant to the pertinent provisions, supervise the use by the insurance
company of its domestic custody account, external foreign exchange use settlement account and securities custody account.
The custody agreement must state the obligations of the domestic custodian as prescribed in Articles 19 and 20 herein. The insurance
company is enpost_titled to terminate the agreement earlier if, in the case of any violation by the domestic custodian of the said obligations,
CIRC or SAFE requires the insurance company to replace the domestic custodian with another one.
Article 23
The following funds fall with the receipts of the domestic custody account of an insurance company:
(1)
foreign exchange fund transferred to the account by the insurance company;
(2)
insurance-related foreign exchange fund remitted to the account from overseas;
(3)
bank deposit principal and interest income;
(4)
interest income from bonds and revenue from sale of bonds;
(5)
interest income from money market derivatives and revenue from the sale thereof; and
(6)
other receipts.
Article 24
The following expenditures fall within the payment of the domestic custody account of an insurance company:
(1)
fund transferred to the external foreign exchange use settlement account;
(2)
insurance-related foreign exchange fund remitted back to the insurance company;
(3)
bank deposit;
(4)
cost paid for the purchase of bonds, including tax payment, such as stamp tax and capital gains tax;
(5)
currency exchange fee, custody fee and asset management fee;
(6)
various service charges; and
(7)
other expenditures.
Article 25
Any overseas commercial bank chosen by a domestic custodian to be its external custody agent shall fulfill the requirements concluded
in the custody agreement.
The domestic custodian shall open an external foreign exchange use settlement account and a securities custody account in respect
of the insurance-related foreign exchange fund with its external custody agent for fund settlement and securities custody business.
Article 26
The domestic custodian shall choose an overseas commercial bank satisfying the following requirements as its external custody agent:
(1)
its paid-in capital being not less than US$2.5 billion or its equivalent in other freely convertible currencies;
(2)
having been of at least grade A or its equivalent of long-term credit as assessed by an internationally accepted rating agency for
the past three years;
(3)
being qualified for a custodian as determined by the regulatory authority of the country or district concerned, or having cooperative
relations with the domestic custodian;
(4)
having a sound corporate governance structure and well-established internal management system and risk control mechanism;
(5)
having a special custody department and personnel of corresponding number who are familiar with the custody business in the country
or district concerned;
(6)
having a safe and efficient clearing and settlement system and emergency mechanism;
(7)
having no record of any heavy punishment in the country or district concerned in the past three years;
(8)
the country or district concerned having a well-defined financial regulatory system, and there being a memorandum of understanding
regarding regulatory cooperation and effective regulatory cooperation relations between the financial regulatory authority of the
country or district concerned and the Chinese financial regulatory authority; and
(9)
other requirements for prudence as prescribed by CIRC and SAFE.
Article 27
The insurance company’s domestic custodian and its external custody agent shall strictly separate their own assets from those under
trust, and set up accounts respectively for, and make separate management of, the overseas use of foreign exchange fund of each insurance
company.
Chapter VI Supervision and Management
Article 28
SAFE may adjust the approved amount of overseas use of insurance-related foreign exchange fund for investment in light of the overall
state of international balance of payment.
Article 29
Any overseas use of foreign exchange fund by an insurance company shall be limited to the provisions of Articles 9 and 10 herein,
and the insurance company may not commit any of the following acts:
(1)
granting a loan to or providing guarantee for others;
(2)
money laundering;
(3)
conspiring with its external trustee, domestic custodian and external custody agent to obtain illegal gains; or
(4)
other acts as prohibited by the pertinent laws or provisions of China or any other country or district concerned.
Article 30
When concluding a pertinent agreement respectively with its external trustee and domestic custodian, an insurance company shall expressly
require the external trustee and domestic custodian to promptly provide the related statements and relevant materials to CIRC and
SAFE.
Article 31
CIRC and SAFE may require the insurance company and its domestic custodian to provide the materials concerning the overseas use of
insurance-related foreign exchange fund and, if necessary, conduct on- site inspection on the insurance company or entrust such inspection
to a professional agency.
Article 32
No overseas commercial bank entrusted with the management of insurance-related foreign exchange fund may concurrently be the domestic
custodian or external custody agent.
Article 33
If any of the following circumstances occurs, the insurance company shall report it to SAFE within five days as of the occurrence:
(1)
any change of its external trustee, domestic custodian or external custody agent;
(2)
any significant change in its registered capital and shareholding structure;
(3)
being involved in any major litigation, subject to any heavy punishment or any other serious matters; and
(4)
other circumstances as prescribed by SAFE.
The insurance company shall also report the occurrence of circumstances under items (1) and (3) of the preceding paragraph to CIRC.
Article 34
If any of the following circumstances occurs, the insurance company’s domestic custodian shall report it to CIRC and SAFE within five
days as of the occurrence:
(1)
any significant change in its registered capital and shareholding structure;
(2)
being involved in any major litigation or subject to any heavy punishment; and
(3)
other matters as prescribed by CIRC and SAFE.
Article 35
Any insurance company and its domestic custodian in violation of the present Measures or any other provisions concerning insurance
and foreign exchange control shall be given by the pertinent regulatory authorities administrative penalties according to their respective
authorities and regulatory functions.
In the case of any gross violation by an insurance company of the present Measures, CIRC may limit the company’s scope of business,
order the company to cease accepting new business or revoke the company’s license for insurance business.
In the case of any gross violation by the domestic custodian of the present Measures, CIRC may order the insurance company to replace
the domestic custodian.
Article 36
If the external trustee entrusted with the management of insurance-related foreign exchange fund breached the pertinent provisions,
CIRC and SAFE may require the insurance company to replace such external trustee.
Chapter VII Supplementary Provisions
Article 37
For the materials submitted to CIRC and SAFE under the present Measures, those in Chinese shall be regarded as the authentic ones.
Article 38
The use by an insurance company of foreign exchange fund in Hong Kong Special Administrative Region and Macao Special Administrative
Region shall be carried out by following the pertinent provisions of the present Measures.
Article 39
The overseas use of foreign exchange fund by an insurance management company shall be carried out by following the present Measures.
Article 40
In the present Measures, day means a working day not including any festival or holiday.
Article 41
The power of interpretation of the present Measures shall be vested in CIRC and the People’s Bank of China.
Article 42
The present Measures shall be implemented as of the date of promulgation.
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China Insurance Regulatory Commission
2004-08-09
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