(Promulgated by Decree No.360 of the State Council of the People's Republic of China on August 4, 2002, and effective as of September 15, 2002)

Chapter 1 General Provisions

Article 1 The Regulations are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law).

Article 2 The drug regulatory department under the State Council shall establish a national drug testing institute.

The drug regulatory departments of the people's governments of the provinces,　autonomous　regions　and municipalities directly under the Central Government may establish drug testing institutes within their respective administrative areas. Plans for the establishment of local drug testing institutes shall be proposed by the drug regulatory departments of the people's governments of the provinces,　autonomous　regions　and municipalities directly under the Central Government and submitted to the people's governments of the provinces,　autonomous　regions　and municipalities directly under the Central Government for approval.

The drug regulatory department under the State Council and the drug regulatory department of the people's government of a province,　autonomous　region　and municipality directly under the Central Government may, when necessary, designate the testing institutes fulfilling the requirements for drug testing to undertake drug testing.

Chapter II Control over Drug Manufacturers

Article 3A Drug Manufacturing Certificate shall be acquired for the establishment of a drug manufacturer according to the following procedures:

(1)The applicant shall submit an application to the drug regulatory department of the people's government of the province,　autonomous　region　or　municipality directly under the Central Government, where the manufacturing site is to be located. The drug regulatory department of the people's government of the province,　autonomous　region　or　municipality directly under the Central Government shall, within 30 working days from the date it receives the application, make a review according to the pharmaceutical industry development programs and policies issued by the State and make a decision on approval or disapproval.

(2)After completion of establishment of the planned manufacturer, the applicant shall apply to the original approving department for acceptance inspection. The original approving department shall, within 30 working days from the date it receives the application, arrange an acceptance inspection according to the requirements for the establishment of such manufacturers set forth in Article 8 of the Drug Administration Law; a Drug Manufacturing Certificate shall be issued to the applicant if the inspection is passed. The applicant shall, by holding the Drug Manufacturing Certificate, register with the administrative department for industry and commerce in accordance with law.

Article 4Any drug manufacturer that intends to alter the approved items in the Drug Manufacturing Certificate shall, 30 days prior to the alteration of any approved items, apply to the original certificate-issuing authority for registration of alteration; no approved items may be altered without approval. The original certificate-issuing authority shall make a decision within 15 working days from the date it receives the application. The applicant shall, by holding the Drug Manufacturing Certificate with altered items, register the alteration with the administrative department for industry and commerce in accordance with law.

Article 5Drug regulatory departments at or above the provincial level shall organize inspection of drug manufacturers in accordance with the Good Manufacturing Practice for Pharmaceutical Products (GMP) and the measures and schedule for implementing the GMP formulated by the drug regulatory department under the State Council, and issue a certificate to the manufacturer that complies with the GMP. For the manufacturers producing injections and radioactive pharmaceuticals and for those producing biological products specified by the drug regulatory department under the State Council, the inspection of which shall be conducted by the drug regulatory department under the State Council.

The format of GMP certificate shall be uniformly provided for by the drug regulatory department under the State Council.

Article 6Any newly-established drug manufacturer or manufacturer with newly-built drug manufacturing workshops or newly-added dosage forms for production shall, within 30 days from the date it obtains the approval documents for manufacturing drug or from the date of its formal production upon approval, apply to the drug regulatory department for GMP certification as required. The drug regulatory department accepting the application shall, within six months from the date it receives the application, organize an inspection as to the compliance with the GMP requirements by the applying manufacturer. A certificate shall be issued to the manufacturer if the inspection is passed.

Article 7The drug regulatory department under the State Council shall set up a database of GMP inspectors. A GMP inspector shall be qualified as required by the drug regulatory department under the State Council. A GMP inspection shall be conducted by a team of inspectors randomly selected from the database of GMP inspectors according to the regulations of the drug regulatory department under the State Council.

Article 8The valid term of a Drug Manufacturing Certificate is five years. To continue its drug production, the Certificate holders shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug Manufacturing Certificate according to the regulations of the drug regulatory department under the State Council.

Where a drug manufacturer terminates its drug production or is closed down, its Drug Manufacturing Certificate shall be withdrawn by the original certificate-issuing authority.

Article 9Any drug substance used by a drug manufacturer to produce drug products shall have a drug approval number or an import drug license or a pharmaceutical product license issued by the drug regulatory department under the State Council upon examination, with the exception of Chinese crude drugs and the prepared slices of Chinese crude drugs over which no control by approval number is exercised.

Article 10In accordance with the provisions in Article 13 of the Drug Administration Law, any drug manufacturer being entrusted with contract production of the drug shall have a GMP certificate corresponding to the contracted drug.

No vaccines, blood products or other drugs specified by the drug regulatory department under the State Council may be contracted for production.