Laws of the People's Republic of China

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 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 entitled 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 inspected entity shall be notified of the inspection result in writing. Where it is necessary to make rectification, the contents and time limit for the rectification shall be put forward and the follow-up inspection shall be implemented.

When making supervision and inspection, the food and drug supervision and administration department shall assign more than two inspectors to carry out supervision and inspection, and the inspectors shall show their certificate documents of law enforcement to the inspected entity. The staff members of the food and drug supervision and administration department shall keep confidential the enterprise technical secrets and business secrets they know.

Article 42

A pharmaceutical production enterprise shall provide the pertinent facts and the following materials during the supervision and inspection:

1.

Self-examination report of the enterprise production conditions and quality control conditions;

2.

Duplicate of the Pharmaceutical Production License and the photocopy of the business license, conditions concerning the alteration of matters in the Pharmaceutical Production License and the examination on it;

3.

Conditions on the organizations of the enterprise, the main managerial personnel taking charge of the production and quality, and the alteration and examination and approval of the testing conditions;

4.

Conditions concerning the pharmaceutical production enterprise's acceptance of supervision and inspection as well as implementation of the rectification;

5.

Conditions concerning the rectification on the disqualified pharmaceuticals after they have been reported in the quality gazette; and

6.

Other necessary materials in need of examination as required by the inspection organs.

After completing the supervision and inspection, the food and drug supervision and administration department shall specify the inspection conditions on the duplicate of the Pharmaceutical Production License, in which the following contents shall be recorded:

1.

Inspection conclusions;

2.

Whether the pharmaceutical produced has occurred any major quality accident, whether there are disqualified pharmaceuticals on which a criticism has been circulated in the quality gazette; and

3.

Whether the pharmaceutical production enterprise has any illegal production acts and the conditions for investigation into and punishment on it.

Article 43

The local food and drug supervision and administration departments at or above the county level shall establish supervision archives for the pharmaceutical production enterprises within their own administrative regions and within the limits of power invested by laws, regulations and rules. The supervision archives shall include such contents as the pharmaceutical production license, production supervision and inspection, supervision over and selective examination on product quality, records of bad acts, and complaints and reports, etc..

Article 44

When carrying out supervision and inspection, the food and drug supervision and administration department may not obstruct the ordinary production activities of any pharmaceutical production enterprise, or seek for or receive the property of pharmaceutical production enterprise, or seek for other interests.

Article 45

When finding out that any pharmaceutical production enterprise is conducting illegal production activities, any individual or organization shall be entitled to report to the food and drug supervision and administration department, who shall then make verification and disposal in time.

Article 46

Where any person in charge of quality control or production of a pharmaceutical production enterprise is altered, the enterprise shall have the resumes and certificate of education background of the person being altered and the relevant conditions reported to and put on archives at 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 enterprise within 15 days after the alteration.

Article 47

Where there is any alteration on the key production facilities of any pharmaceutical production enterprise, the enterprise shall report it to and 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 as of the date of occurring alteration. The food and drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government shall make inspection when necessary.

Article 48

Where any pharmaceutical production enterprise has any major quality accident, it shall immediately report to the food and drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government where it is located. The food and drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government shall report to the State Food and Drug Administration within 24 hours.

Article 49

Where there is any one of the circumstances as prescribed in the Administrative License Law of the People's Republic of China (hereinafter referred to as the "Administrative License Law"), the original license issuing organ shall revoke the Pharmaceutical Production License ipso jure, and notify the relevant administrative department for industry and commerce within 5 workdays as of the date of revocation, and announce to the society simultaneously.

Chapter VI Legal Liabilities

Article 50

Where there is any one of the circumstances as prescribed in Article 69 of the Administrative License Law, the State Food and Drug Administration or the food and drug supervision and administration departments of the provinces, autonomous regions, and municipalities directly under the Central Government may revoke the Pharmaceutical Production License upon the petition of the interested parties or according to their authority.

Article 51

Where any applicant disguises the relevant conditions or provides false materials to file an application for Pharmaceutical Production License, the food and drug supervision and administration departments of the provinces, autonomous regions, and municipalities directly under the Central Government shall reject it or not grant approval, and give it warnings, and shall not accept the application of the applicant within 1 year.

Where an applicant provides false materials or takes other deceptive means to obtain Pharmaceutical Production License, the food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under the Central Government shall revoke the Pharmaceutical Production License, and reject its application within 5 years, and impose on it a fine of RMB 10 thousand Yuan through RMB 30 thousand Yuan.

Article 52

Any pharmaceutical production enterprise that produces pharmaceuticals without obtaining Pharmaceutical Production License shall be punished according to the provisions of Article 73 of the Pharmaceutical Administration Law.

Article 53

Where any enterprise entrusts or accepts entrustment to produce pharmaceuticals without authorization, the entrusting party and the entrusted party shall be subject to penalties according to the provisions of Article 74 of the Pharmaceutical Administration Law.

Article 54

Where a pharmaceutical production enterprise has any of the following circumstances, the food and drug supervision and administration department shall give it a punishment in accordance with the provisions of Article 79 of the Pharmaceutical Administration Law:

1.

The pharmaceutical production enterprise fails to carry out the Pharmaceutical Production Quality Control Criterions as required; or

2.

In the case of the establishment of pharmaceutical production enterprise, or in case the pharmaceutical production enterprise builds new production workshops or adds new production medicament types, the enterprise fails to pass the certification of Pharmaceutical Production Quality Control Criterions within the time as prescribed in Article 6 , but still carries out production.

Article 55

In case a pharmaceutical production enterprise fails to reach the appraisal standards as prescribed in the Pharmaceutical Production Quality Control Criterions after supervision and inspection (including follow-up inspection, supervision and selective examination), the original certification organ shall make decisions on taking back the certification certificate of the Pharmaceutical Production Quality Control Criterions.

Article 56

Where any pharmaceutical production enterprise has any of the following circumstances, the food and drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government at its locality shall give it warnings, order it to set right within a prescribed time limit. If it fails to get right within the time limit, it shall be punished by a fine of RMB 5,000 Yuan through RMB 10 thousand Yuan:

1.

Failing to conduct alteration of registration matters in the Pharmaceutical Production License as required;

2.

Accepting the entrustment of any overseas pharmaceutical factory to process pharmaceuticals within the territory of China, and failing to put it on archives as required;

3.

Failing to report the alteration of any person responsible for quality or production of the enterprise as required;

4.

Failing to put on archives the changes on the key production facilities and status of the enterprise as required;

5.

Failing to report the occurrence of any major pharmaceutical quality accident as required; or

6.

Disguising the relevant conditions, providing false materials or refusing to provide the relevant documents during the supervision and inspection.

Article 57

Where any food and drug supervision and administration department violates regulations, issues certification certificate of Pharmaceutical Production Quality Control Criterions to those not corresponding with the Pharmaceutical Production Quality Control Criterions or fails to perform duty of follow-up inspection on any enterprise that has obtained certification certificate, or fails to order any enterprise that does not accord with the certification conditions to correct ipso jure, or issue Pharmaceutical Production License to any entity not complying with the legal conditions, it shall be subject to the penalties as prescribed in Article 94 of the Pharmaceutical Administration Law.

Article 58

The violations of the relevant laws and regulations in the implementation of the administrative license as prescribed in the present Measures shall be punished according to the relevant laws and regulations.

Chapter VII Supplementary Provisions

Article 59

The power to interpret the present Measures shall remain with the State Food and Drug Administration.

Article 60

The present Measures shall be implemented as of the date of promulgation. The Measures for the Supervision over and Administration of Pharmaceutical Production (for Trial Implementation) as promulgated by State Food and Drug Administration on December 11th, 2002 shall be abolished simultaneously.