Implementing Regulations of the Drug Administration Law of the People's Republic of China

Implementing Regulations of the Drug Administration Law of the People's Republic of China


Implementing Regulations of the Drug Administration Law of the People's Republic of China

Order of the State Council [2002]No. 360

August 4, 2002

These Implementing Regulations of the Drug Administration Law of the People's Republic of China are hereby promulgated and shall come into effect as of September 15, 2002.

Premier: Zhu Rongji

Appendix: Implementing Regulations of the Drug Administration Law of the People's Republic of China

Chapter I General Provisions

Article 1 These 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 pharmaceutical regulatory department under the State Council shall establish state pharmaceutical inspection institute.
The pharmaceutical regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government may establish pharmaceutical inspection institute within its respective administrative area. The plan for the establishment of local pharmaceutical inspection institutes shall be proposed by the pharmaceutical regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government and submitted to the people's government of the province, autonomous region and municipality directly under the Central Government for approval.
The pharmaceutical regulatory department under the State Council and the pharmaceutical regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government may, when necessary, designate inspection institute fulfilling the requirements for pharmaceutical inspection to undertake the pharmaceutical inspection.

Chapter II Administration of the Pharmaceutical Producing enterprises

Article 3 A Drug Manufacturing Certificate shall be acquired for the establishment of a pharmaceutical manufacturer according to the following procedures:
1. The applicant shall submit an application to the pharmaceutical 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 pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days after it receives the application, make an examination according to the development programs and policies of pharmaceutical industry issued by the State and make a decision on whether approve or disapprove the preparation and establishment of the pharmaceutical manufacturer.
2. After completion of the preparation and 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 after it receives the application, arrange an acceptance inspection according to the requirements for the establishment of such producing enterprises as set forth in Article 8 of the Drug Administration Law; and a Drug Manufacturing Certificate shall be issued to the applicant if the inspection is passed. The applicant shall, based on the Drug Manufacturing Certificate, conduct the registration at the administrative department for industry and commerce in accordance with laws.

Article 4 Any pharmaceutical 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 the registration of alteration; no approved items shall be altered without approval. The original certificate-issuing authority shall make a decision within 15 working days after it receives the application. The applicant shall, based on the Drug Manufacturing Certificate with items altered, register the alteration at the administrative department for industry and commerce in accordance with laws.

Article 5 The pharmaceutical regulatory department of the people's government at or above the provincial level shall organize the inspections of drug manufacturing enterprises in accordance with the Good Manufacturing Practice for Pharmaceutical Products (GMP) and the measures and schedule for the implementation of the GMP formulated by the pharmaceutical regulatory department under the State Council, and issue a certificate to the manufacturer that complies with the GMP. For the manufacturer producing injections or radioactive pharmaceuticals and for those producing biological products specified by the pharmaceutical regulatory department under the State Council, the inspection of which shall be conducted by the pharmaceutical regulatory department under the State Council.
The format of GMP certificate shall be uniformly provided for by the pharmaceutical regulatory department under the State Council.

Article 6 Any newly-established drug manufacturer or manufacturer with newly -built pharmaceutical manufacturing workshops or newly-added dosage forms for production shall, within 30 days after it obtains the approval documents for drug manufacturing or after its formal production is approved, apply to the pharmaceutical regulatory department for GMP certification as required. The pharmaceutical regulatory department accepting the application shall, within six months after it receives the application, organize inspections 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 7 The pharmaceutical regulatory department under the State Council shall set up a database of GMP inspectors. A GMP inspector shall be qualified as required by the pharmaceutical 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 provisions of the pharmaceutical regulatory department under the State Council.

Article 8 The valid term of a Drug Manufacturing Certificate is five years. To continue its pharmaceutical production, the Certificate holder shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug Manufacturing Certificate according to the provisions of the pharmaceutical regulatory department under the State Council.
Where a pharmaceutical manufacturer terminates its pharmaceutical production or is closed down, its Pharmaceutical Manufacturing Certificate shall be withdrawn by the original certificate-issuing authority.

Article 9 The bulk pharmaceutical chemicals used by a pharmaceutical manufacturer to produce pharmaceutical products shall have a pharmaceutical approval number or an import pharmaceutical license or a pharmaceutical product license issued by the pharmaceutical regulatory department under the State Council upon examination, with the exception of Traditional Chinese medicines and the prepared slices of Traditional Chinese medicines over which no control by approval number has been carried out.

Article 10 In accordance with Article 13 of the Drug Administration Law, any pharmaceutical manufacturer being entrusted with contract production of pharmaceuticals shall have a GMP certificate corresponding to the contracted pharmaceutical.
The production of vaccines, blood products or other pharmaceuticals specified by the pharmaceutical regulatory department under the State Council shall be sub-contracted.

Chapter III Administration of Pharmaceutical Trading Enterprises

Article 11 For the establishment of a pharmaceutical wholesale enterprise, the applicant shall apply to the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, where the planned pharmaceutical wholesale enterprise is to be located. The pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days after it receives the application, make a decision on whether to approve or disapprove the preparation and establishment of the enterprise according to the standards for establishment provided by the pharmaceutical regulatory department under the State Council. After the completion of the establishment of the planned wholesale enterprise, the applicant shall apply to the original approving department for acceptance inspection. The original approving department shall, within 30 working days after it receives the application, organize an acceptance inspection according to the requirements for the establishment of pharmaceutical trading enterprises as set forth in Article 15 of the Drug Administration Law and issue the Drug Supply Certificate to the applicant if the inspection is passed. The applicant shall, based on the Certificate, register at the administrative department for industry and commerce in accordance with the laws.

Article 12 For the establishment of a pharmaceutical retailer, the applicant shall submit an application to the pharmaceutical regulatory institution of the municipality divided into districts, or to the pharmaceutical regulatory institution at the county level which is directly set up by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, where the planned retailer is to be located. The pharmaceutical regulatory institution accepting the application shall, within 30 working days after it receives the application, make a decision on whether to approve or disapprove the establishment after the review according to the provisions of the pharmaceutical regulatory department under the State Council, taking into consideration of the number of permanent residents, territory, transportation and practical needs at the local place. After the completion of the establishment of the planned retailer, the applicant shall apply to the original approving department for acceptance inspections. The original approving department shall, within 15 working days after it receives the application, organize acceptance inspections according to the requirements for the establishment of pharmaceutical trading enterprises as set forth in Article 15 of the Drug Administration Law and issue a Drug Supply Certificate if the inspections are passed. The applicant shall, based on the Certificate, register at the administrative department for industry and commerce in accordance with the laws.

Article 13 The pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall be responsible for the certification of pharmaceutical trading enterprises. A pharmaceutical trading enterprise shall, according to the implementing measures and schedule formulated by the pharmaceutical regulatory department under the State Council, undergo the Good Distribution Practices (GDP)for Pharmaceutical Products inspections organized by the local pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government and obtain a Good Distribution Practices (GDP)for Pharmaceutical Products Certificate. The format of Good Distribution Practices (GDP) for Pharmaceutical Products Certificate shall be uniformly provided for by the pharmaceutical regulatory department under the State Council.
Any newly-established pharmaceutical wholesale or retailer shall, within 30 days after it obtains the Drug Supply Certificate, apply for the GSP certification to the pharmaceutical regulatory department or institution which has issued the Drug Supply Certificate.
  ......
Please consent to the LexisNexis Terms and Conditions and Privacy Policy.