Implementing Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2019)
Implementing Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2019)
Implementing Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2019)
Order of the State Council of the People's Republic of China No.709
March 2, 2019
(Promulgated by the Order of the State Council of the People's Republic of China No.360 on August 4, 2002; and revised in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on February 6, 2016; and amended according to the Decision of the State Council on Revising Certain Administrative Regulations on March 2, 2019)
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 To establish a drug manufacturer, 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 central government where the manufacturer is to be located. The drug regulatory department of the people's government of the province, autonomous region or municipality directly under central government 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 in Article 8 of the Drug Administration Law, and issue a Drug Manufacturing Certificate to the applicant if the inspection is passed.
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.
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.
Article 44 Packaging materials and containers selected for the production of prepared slices of the traditional Chinese medicine shall accommodate to pharmaceutical properties.
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Order of the State Council of the People's Republic of China No.709
March 2, 2019
(Promulgated by the Order of the State Council of the People's Republic of China No.360 on August 4, 2002; and revised in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on February 6, 2016; and amended according to the Decision of the State Council on Revising Certain Administrative Regulations on March 2, 2019)
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 To establish a drug manufacturer, 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 central government where the manufacturer is to be located. The drug regulatory department of the people's government of the province, autonomous region or municipality directly under central government 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 in Article 8 of the Drug Administration Law, and issue a Drug Manufacturing Certificate to the applicant if the inspection is passed.
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.
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.
Article 44 Packaging materials and containers selected for the production of prepared slices of the traditional Chinese medicine shall accommodate to pharmaceutical properties.
......