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
