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Pharmaceutical & Cosmetic
Provisions for Drug Manufacturing Supervision
    Pubtime: 2012-03-20

Chapter 1 General Provisions
Article 1 The Provisions is formulated with a view of strengthening supervision over drug manufacturing and in accordance with the Drug Administration Law of the People’s Republic of China and Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the Drug Administration Law and Regulations for Implementation of the Drug Administration Law).

Article 2 Supervision over drug manufacturing refers to administrative activities including examination, approval, supervision and inspection on the condition and process of drug manufacturing,which are conducted by (food and) drug regulatory departments in accordance with law.

Article 3 The State Food and Drug Administration is responsible for the supervision and administration of drug manufacturing throughout the country; the (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for supervision and administration of drug manufacturing within their respective administrative areas.

Chapter 2 Application and Approval for Establishment of A Drug Manufacturer
Article 4 To establish a drug manufacturer, the applicant shall, besides complying with the development programs and policies issued by the State for pharmaceutical industry, meet the following requirements:
(1) Having legally qualified pharmaceutical personnel, engineering personnel and necessary technical workers, and the legal representative or head of the enterprise and person in charge of quality are not involved in any of the situations specified in Article 76 of the Drug Administration Law;
(2) Having factory buildings, facilities and a sanitary environment appropriate for its drug manufacturing;
(3) Having organizations, personnel and necessary instruments and equipment appropriate for quality control and testing of the drugs to be produced.
(4) Having rules and regulations ensuring quality of its drugs.
Where there are other provisions on manufacturing of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs or pharmaceutical precursor chemicals in relevant laws and regulations of the State, these provisions shall prevail.

Article 5 The applicant for establishment of a drug manufacturer shall file an application with the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government, where the manufacturer is to be located, and submit the following materials.
(1) Basic information of the applicant and relevant proof documents;
(2) Basic information about the manufacturer to be established, including name of the manufacturer, product variety and dosage form(s), equipment, processes and production capacity; description of conditions such as the site, surroundings and infrastructure of the manufacturer and explanation on investment size;
(3) Notice of pre-approval on the name of the manufacturer to be established issued by the administrative department for industry and commerce, address of manufacturing address of manufacturing site, registered address, type of enterprise and legal representative or head of the enterprise;
(4) Organization chart of the manufacturer to be established (responsibilities of various departments, their interrelations and heads shall be indicated);
(5) Resumes, educational qualifications and professional title certificates of the legal representative, head and department heads of the enterprise to be established; registration forms of legally qualified pharmaceutical professionals, engineering personnel and technical workers in the pharmaceutical field and relevant fields (their departments and positions shall be indicated); proportion statement of senior, intermediate and junior technical personnel.
(6) Plan of surrounding areas, master plan layout, warehouse plan and quality inspection site plan of the manufacturer to be established;
(7) Layout chart of production processes (including change room, lavatory, passages for people and materials, air lock, etc., and directions of flows of people and materials and air cleanliness class shall be indicated), layout chart of air purification system indicating air supply, air return and discharge pipes and layout chart of processing equipment;
(8) Range, dosage forms and varieties of products to be produced, and quality specifications with their basis;
(9) Process flow chart of the dosage form and variety of product to be produced. Main quality control points and items shall be indicated;
(10) Summary of verification on the air purification system, water generation system and main equipment; information on calibration of instruments, meters and weighing apparatuses for production and testing;
(11) List of main production equipment and testing instruments;
(12) List of production management and quality management documents of the manufacturer to be established.
The applicant shall be responsible for the authenticity of all the application materials.

Article 6 Where a drug manufacturer spins off part of its production plants into an independent drug manufacturer, a Drug Manufacturing Certificate shall be applied for in accordance with requirements of Article 4 and Article 5 of the Provisions.

Article 7 After receiving an application, the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall handle the application according to the following situations:
(1) Where an application item is not subject to the jurisdiction of the department, the department shall immediately make a non-acceptance decision and advise the applicant to apply to a relevant administrative authority;
(2) Where an error in the application dossier can be corrected on the spot, on-the-spot correction shall be allowed;
(3) Where the dossier is incomplete or not conformed with the defined format, the applicant shall be given a Notice for Supplementary Materials on the spot or within five working days, in which all the content required to be supplemented and corrected are informed at one time; where the applicant is not informed within the timeline, the application is deemed as accepted on the date the dossier is received;
(4) Where the application dossier is complete and in compliance with the requirements of preliminary review or the applicant has submitted all the materials added and corrected as required, the application shall be accepted.
Where the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government accepts or rejects an application for establishment of a drug manufacturer, it shall issue a dated Acceptance Notice or Non-acceptance Notice affixed with the specified seal for acceptance of the department.

Article 8 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall make a decision within 30 working days from the date an application is received.
Where the application is confirmed in compliance with the requirements after review, the department shall approve the application and issue a Drug Manufacturing Certificate to the applicant within 10 working days from the date it makes the approval decision in writing; where the application is found not in compliance with the requirements, the department shall make a disapproval decision in writing, explain the reason thereof and meanwhile inform the applicant of the right to apply for an administrative reconsideration or to bring an administrative suit by law.

Article 9 To establish a new drug manufacturer or to build a new drug production plant or to add a new dosage form, the manufacturer shall, within 30 days from the date of obtaining the certificate for drug production or the approval for formal production, apply for a Good Manufacturing Practice for Pharmaceutical Products (GMP) certification with relevant (food and) drug regulatory department in accordance with relevant regulations of the State Food and Drug Administration.

Article 10 The (food and) drug regulatory department of an province, autonomous region or municipality directly under the Central Government shall publicize the conditions, procedure, time limit, list of all the materials needed to be submitted for application for Drug Manufacturing Certificate and model text of the application form on its website and at the workplace.
The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall publicize the information on issuance of the Drug Manufacturing Certificate , and the public has the right of checking and viewing.

Article 11 When examining an application for establishing a drug manufacturer, the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall publicize the process and result of examination and approval. For items directly involving their vital interests, the applicant and interested parties may submit written opinions to make statements and arguments.

Article 12 Where an application for establishment of a drug manufacturer directly involves the vital interests between the applicant and others, the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall advise the applicant and interested parties of their right to apply for a hearing in accordance with relevant laws, regulations and other provisions of the State Food and Drug Administration. The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall make public and hold a hearing (hearings) on a permission item which it deems is of significance to public interests in the course of examining the application for establishment of a drug manufacturer.

Chapter 3 Management of the Drug Manufacturing Certificate
Article 13 The Drug Manufacturing Certificate shall include a formal edition and a counterpart, both have equal legal effect and a validity period of five years.
The Drug Manufacturing Certificate is uniformly printed by the State Food and Drug Administration.
Article 14 The Drug Manufacturing Certificate shall specify items such as the certificate number, name of the enterprise, legal representative and head of the enterprise, type of the enterprise, registered address, address of manufacturing site, scope of production, issuing authority, date of issue and validity period. Of these, the head of the enterprise, scope of production and address of manufacturing site are permission items which have been approved by a (food and) drug regulatory department. Name of the enterprise, legal representative, registered address and type of the enterprise shall be consistent with those in the business license issued by the administrative department for industry and commerce.
Name of the enterprise shall be filled in according to the principle of classification of drug manufacturers; the address of manufacturing site shall be filled in as the actual address of drug production; the certificate number and scope of production shall be filled in according to the method and category prescribed by the State Food and Drug Administration.

Article 15 Change of the Drug Manufacturing Certificate is classified into change of permission items and change of registry items.
Change of permission items refers to change of the head of the enterprise, scope of production and manufacture address.
Change of registry items refers to change of items specified in paragraph 2 of Article 14 of the Provisions.

Article 16 To change a permission item in the Drug Manufacturing Certificate, a drug manufacturer shall apply for change to the original issuing authority 30 days in advance based on the date of change of the original permission item. No permission items shall be changed without permission.
The original issuing authority shall decide whether or not to approve the change within 15 working days from the date the application is received. If the change is not approved, the issuing authority shall explain the reason thereof in writing and advise the applicant of the right to apply for an administrative reconsideration or bring an administrative suit by law.
To change the production scope or address of manufacturing site, a drug manufacturer shall submit materials concerning the change to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government for review and approval according to the requirements of Article 5 of the Provisions.
After completing the procedure for changing permission items in the Drug Manufacturing Certificate in accordance with law, the drug manufacturer shall timely go through the procedure for changing registration of the enterprise at the administrative department for industry and commerce.

Article 17 To change a registry item in the Drug Manufacturing Certificate, a drug manufacturer shall apply for change of a registry item to the original issuing authority within 30 days after the change is approved by the administrative department for industry and commerce. The original issuing authority shall complete the change procedure within 15 working days after receiving the application for change.

Article 18 After a Drug Manufacturing Certificate is changed, the original issuing authority shall record the content and date of the change on the counterpart of the Drug Manufacturing Certificate, reissue a new Drug Manufacturing Certificate according to the changed content and withdraw the original of the old Drug Manufacturing Certificate. The validity period of the changed Drug Manufacturing Certificate remains unchanged.

Article 19 To continue drug production upon expiration of a Drug Manufacturing Certificate, the drug manufacturer shall apply for a renewal of the Drug Manufacturing Certificate to the original issuing authority within six months prior to the certificate expiration.
The original issuing authority shall, in view of the enterprise’s performance of complying with relevant laws and regulations, the GMP and operation of the quality system, conduct an examination in accordance with the procedures and requirements of the Provisions concerning establishment of drug manufacturers, and decide whether or not to grant a renewal before expiration of the Drug Manufacturing Certificate. For an application in conformity with relevant provisions, the issuing authority shall withdraw the original certificate and issue a new one; for an application not in conformity with relevant provisions, the issuing authority shall make a decision of not approving the renewal of the certificate in writing, explain the reason thereof, and meanwhile advise the applicant of the right to apply for an administrative reconsideration or bring an administrative suit by law. If no decision is made within the time limit, the issuing authority shall be considered as approving the renewal of the certificate and complete relevant procedures.

Article 20 Where a drug manufacturer stops production or is closed, the original issuing authority shall take back the Drug Manufacturing Certificate for cancellation and report the matter to the administrative department for industry and commerce.

Article 21 Where a Drug Manufacturing Certificate is lost, the drug manufacturer shall immediately apply for a reissuance to the original issuing authority and publish a declaration of loss in a media designated by the original issuing authority. The original issuing authority shall reissue the Drug Manufacturing Certificate within 10 working days after the declaration of loss has been published for one month.

Article 22 No organization or individual may falsify, alter, merchandise, lease or lend a Drug Manufacturing Certificate.

Article 23 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall report matters concerning issuance, renewal, change, reissuance, revocation, withdrawal, taking back for cancellation and cancellation of the Drug Manufacturing Certificate to the State Food and Drug Administration for the record within 20 working days after the procedure is completed. The issuing authority shall keep the Drug Manufacturing Certificate withdrawn or cancelled in accordance with law on file for five years.

Chapter 4 Administration of Contract Manufacturing of Drugs

Article 24 The party who entrusts drug production shall be a drug manufacturer who has obtained an approval number for the drug.

Article 25 The party who accepts the entrustment of drug production shall be a drug manufacturer who has a GMP certificate corresponding to production conditions of the drug.

Article 26 The entrustor is responsible for quality and sales of the contract manufactured drug. The entrustor shall scrutinize the entrustee’s production conditions, manufacturing techniques and quality management status, provide technical and quality documents of the drug to the entrustee, and direct and supervise the entire production process.
The entrustee shall carry out production in accordance with the GMP and keep all the documents and records relating to contract manufacturing as required.

Article 27 The two parties of the drug contract manufacturing shall sign a contract which shall cover the rights and obligations of both parties, specify the two parties’ rights and obligations with respect to manufacturing techniques and quality control in contract drug manufacturing, and comply with the laws and regulations of the State for drug administration.

Article 28 Application for contract manufacturing of an injection, biological product (not including vaccines and blood products) or contract manufacturing of cross-province, autonomous region or municipality directly under the Central Government shall be accepted, examined and approved by the State Food and Drug Administration.
Vaccines, blood products and other drugs prescribed by the State Food and Drug Administration shall not be contract manufactured.
Contract manufacturing of a narcotic drug, psychotropic drug, toxic drug for medical purpose, radioactive drug and pharmaceutical precursor chemical shall be conducted in accordance with relevant laws and regulations.

Article 29 Application for contract manufacturing of drugs other than those specified in Article 28 of the Provisions shall be accepted, examined and approved by the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government of the place where the two parties of the contract manufacturing are located.

Article 30 To apply for drug contract manufacturing, the entrustor shall file an application with the State Food and Drug Administration or the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government and submit application materials specified in Article 34 of the Provisions. The (food and) drug regulatory department shall accept the application in accordance with requirements of Article 7 of the Provisions.

Article 31 The (food and) drug regulatory department shall, within 20 working days from the date of accepting the application, examine the application for drug contract manufacturing and make a decision according to conditions specified in this chapter; if the department cannot make a decision within 20 working days, the time limit can be extended for 10 working days upon approval by the head of the department, and the reason for extending the time limit shall be notified to the entrustor.
Where the application is confirmed in compliance with the requirements, the department shall approve the application and issue an Approval for Drug Contract Manufacturing to the entrustor within 10 working days from the date it makes the approval decision in writing; where the application is found not in compliance with the requirements, the department shall notify the applicant in writing and explain the reason thereof, and meanwhile advise the applicant of the right to apply for an administrative reconsideration or bring an administrative suit by law.

Article 32 The validity period of the Approval for Drug Contract Manufacturing shall not exceed two years and the validity period prescribed in the approval document of the drug.

Article 33 To continue contract manufacturing upon expiration of the Approval for Drug Contract Manufacturing, the entrustor shall submit relevant materials in accordance with requirements of Article 34 of the Provisions 30 days in advance based on the expiration of the validity period and complete the formalities for extension.
Upon expiration of the manufacturing contract, the entrustor shall timely go through the formalities for canceling the Approval for Drug Contract Manufacturing.

Article 34 Application materials for drug contract manufacturing include:
(1) Copies of the Drug Manufacturing Certificates and business licenses of the entrustor and entrustee;
(2) Copy of the GMP certificate of the entrustee;
(3) Information about the entrustor’s evaluation of the entrustee's production and quality assurance conditions;
(4) Copy of the approval document of the drug to be contract manufactured, attached with the specifications, manufacturing techniques, samples of package, label and insert sheet;
(5) Format and color mark of the package, label and insert sheet to be used for the contract manufactured drug;
(6) Manufacturing contract;
(7) Product testing report for three consecutive batches issued by the provincial drug testing institute of the place where the entrustee is located. Where contract manufacturing of a biological product is conducted, the provincial drug testing institute of the place where the entrustee is located shall take samples from three batches of the product and seal the samples; the National Institute for the Control of Pharmaceutical and Biological Products is responsible for testing the samples and issuing the testing report;
(8) Opinion of the drug regulatory department of the province, autonomous region or municipality directly under the Central Government of the place where the entrustee is located on the enterprise’s production conditions and capacity including technical personnel, factory buildings, facilities and equipment as well as quality assurance systems of the quality testing organization and testing equipment after examination.
Materials needed for applying for extension of drug contract manufacturing:
(1) Copies of the Drug Manufacturing Certificates and business licenses of the entrustor and entrustee;
(2) Copy of the GMP certificate of the entrustee;
(3) Copy of the previous Approval for Drug Contract Manufacturing;
(4) Summary of production and quality during the previous period of contract manufacturing;
(5) Proof document(s) of change(s) to the previous Approval for Drug Contract Manufacturing.

Article 35 The national drug quality standard shall be applied to the contract manufactured drug as its specifications. The formula, manufacturing techniques, packaging specification, label, insert sheet and approval number shall be consistent with those originally approved. The name and registered address of the entrustor and the name and address of manufacturing site of the entrustee shall be marked on the package, label and insert sheet of the contract manufactured drug.

Article 36 The (food and) drug regulatory departments shall refer to and implement relevant requirements of Article 10 to Article 12 in Chapter 2 of the Provisions when examining application for drug contract manufacturing.

Article 37 Where a drug manufacturer accepts an entrustment of an overseas drug manufacturer to process a drug in China, it shall report the matter to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government within 30 days after the manufacturing contract is signed. The processed drug shall not be sold or used in any form within the territory of China.

Article 38 The (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall report to the State Food and Drug Administration matters relating to approval and filing of drug contract manufacturing.

Chapter 5 Supervision and Inspection
Article 39 The (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for supervising and inspecting drug manufacturers within their respective administrative areas and shall establish and implement an operation mechanism and regulatory system for supervision and inspection, and define the supervision and inspection responsibilities of municipal (food and) drug regulatory departments in cities consisting of districts and county-level (food and) drug regulatory departments.
The State Food and Drug Administration may directly supervise and inspect drug manufacturers and meanwhile carry out supervision and random inspection over the supervision and inspection work of (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government, and the GMP implementation and certification status of the certified manufacturers.

Article 40 Supervision and inspection mainly covers drug manufacturers’ implementation of relevant laws, regulations and the GMP, including on-site inspection for renewal of the Drug Manufacturing Certificate, follow-up inspection of implementation of the GMP and daily supervision inspection.

Article 41 When organizing a supervision inspection, the (food and) drug regulatory department at each level shall draw up an inspection plan, specify inspection standards, faithfully record information about the on-site inspection, notify the inspected organization of the result in writing, propose items to be rectified (if any) with a rectification time limit and carry out follow-up inspection.
The (food and) drug regulatory department shall designate more than two inspectors to carry out supervision inspection. The inspectors shall show the inspected organization their law enforcement certificates. Staff of the (food and) drug regulatory department shall keep confidential the enterprise’s technical and business secrets which they have known.

Article 42 A drug manufacturer shall provide relevant information and the following materials at the time of supervision inspection:
(1) Self-inspection report on production and quality management of the manufacturer;
(2) Counterpart of the Drug Manufacturing Certificate and copy of the business license; information about change of items in the Drug Manufacturing Certificate and the approval of the change;
(3) Information about change of the manufacture’s organizational structure, key personnel for production and quality management and testing conditions, as well as the approval of the change;
(4) Information about supervision inspection received by the manufacturer and status of implementing rectification;
(5) Information about rectification after substandard drugs are announced on the quality bulletin;
(6) Other necessary materials to be examined by the inspection authority.
After the supervision inspection is completed, the (food and) drug regulatory department shall indicate the information about the inspection in the counterpart of the Drug Manufacturing Certificate and write down the following items.
(1) Inspection conclusion;
(2) Whether the product is involved in any serious quality-related accident, whether there is any substandard drug announced on the drug quality bulletin;
(3) Whether the drug manufacturer has committed any act of illegal production, and status of investigation and punishment received.

Article 43 The (food and) drug regulatory departments above the county-level shall, within their authority conferred by relevant laws, rules and regulations, establish supervision files for drug manufacturers within their administrative areas. Supervision files cover the licensing of drug production, supervision inspection of production, supervision and random inspection of product quality, records of undesirable conducts, complaints and reports.

Article 44 The (food and) drug regulatory departments shall not obstruct normal production activities of drug manufacturers, ask for or accept money or things of value from drug manufacturers or seek other benefits during supervision inspection.

Article 45 An individual or organization, who finds a drug manufacturer is engaged in any activity of illegal production, has the right to report the offence to the (food and) drug regulatory department. The (food and) drug regulatory department shall investigate and handle the case timely.

Article 46 Where the person in charge of quality or the person in charge of production of a drug manufacturer is changed, the relevant materials, including resume and academic certification of the person after change, shall be reported to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government for the record.

Article 47 Where conditions such as critical production facilities of a drug manufacturer are changed, the change shall be reported to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government for the record, within 30 days from the date of change. The said (food and) drug regulatory department shall carry out inspection as needed.

Article 48 Where a serious drug-quality-related accident occurs, the drug manufacturer must immediately report it to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government and relevant departments. The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall report the accident to the State Food and Drug Administration within 24 hours.

Article 49 In any of the circumstances described in Article 70 of the Administrative Permission Law of the People's Republic of China (hereinafter referred to as the Administrative Permission Law), the original issuing authority shall cancel the Drug Manufacturing Certificate in accordance with law, notify the administrative department for industry and commerce within five working days from the date the certificate is cancelled, and meanwhile make the case known to the public.

Chapter 6 Legal Liabilities
Article 50 In any of the circumstances described in Article 69 of the Administrative Permission Law, the State Food and Drug Administration or the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government may withdraw the Drug Manufacturing Certificate at the request of the interested party or by virtue of its authority.

Article 51 Where an applicant conceals relevant information or provides false application materials to apply for a Drug Manufacturing Certificate, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall refuse to accept or to approve the application and give a warning, and no application submitted by the applicant may be accepted within one year.
Where an applicant has obtained a Drug Manufacturing Certificate by providing false materials or other deceptive means, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall revoke its Drug Manufacturing Certificate, refuse to accept any application submitted by the said applicant within five years and impose a fine of not less than RMB 10,000 Yuan but not more than RMB 30,000 Yuan.

Article 52 Anyone producing a drug without a Drug Manufacturing Certificate shall be punished in accordance with the provisions in Article 73 of the Drug Administration Law.

Article 53 Anyone entrusting or accepting a contract manufacturing without permission shall be punished in accordance with the provisions in Article 74 of the Drug Administration Law.

Article 54 In any of the following circumstances, a drug manufacturer shall be punished by the (food and) drug regulatory department in accordance with the provisions in Article 79 of the Drug Administration Law:
(1) Where the drug manufacturer fails to implement the GMP as required;
(2) Where the enterprise, which is a newly established drug manufacturer or has built a new pharmaceutical production department or added a new dosage form, fails to pass the GMP certification within the time limit specified in Article 6 of the Regulations for Implementation of the Drug Administration Law but still engages in production.

Article 55 Where a drug manufacturer is deemed as not meeting the evaluation standard of the GMP after supervision inspection (including follow-up inspection and random inspection), the original issuing authority shall make a decision of withdrawing the GMP certificate of the enterprise according to this inspection result.

Article 56 In any of the following circumstances, a drug manufacturer shall be warned and ordered to make corrections within a time limit by the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government; anyone who fails to make corrections within the time limit will be liable to a fine of not less than RMB 5,000 Yuan but not more than RMB 10,000 Yuan.
(1) Failing to apply for change of registry items in a Drug Manufacturing Certificate as required;
(2) In the case of accepting an entrustment from an overseas drug manufacturer to process a drug in China, failing to submit relevant materials for the record as required;
(3) Failing to report the change of the person in charge of quality and person in charge of production of the enterprise as required;
(4) Failing to put on record the change of conditions and current situations such as critical production facilities of the enterprise as required;
(5) Failing to report serious drug quality-related accident(s) as required;
(6) Concealing relevant information, providing false materials or refusing to provide relevant materials at the time of supervision inspection;

Article 57 Where a (food and) drug regulatory department, in violation of relevant regulations, issues a GMP certificate to an enterprise that is not in compliance with the GMP or fails to perform, in accordance with regulations, the duty of follow-up inspection over an enterprise who has obtained the certificate, fails to order an enterprise that does not comply with the requirements for certification to make corrections or issues a Drug Manufacturing Certificate to an enterprise not complying with the statutory requirements, the department shall be punished according to Article 94 of the Drug Administration Law.

Article 58 Anyone who violates relevant laws and regulations in implementing administrative permission stipulated by the Provisions shall be dealt with in accordance with relevant laws and regulations

Chapter 7 Supplementary Provisions
Article 59 The State Food and Drug Administration is responsible for interpretation of the Provisions.

Article 60 The Provisions shall go into effect as of the date of promulgation. The Provisions for Drug Manufacturing Supervision (for trial implementation) promulgated by the State Food and Drug Administration on December 11, 2002 shall be annulled there from.

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