Decree of the State Council of the People’s Republic of China
No. 360
The Regulations for Implementation of the Drug Administration Law of the People’s Republic of China are hereby promulgated and shall go into effect as of September 15, 2002.
Premier: Zhu Rongji
August 4, 2002
Regulations for Implementation of the Drug Administration Law of the People’s Republic of China
Chapter I
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 department of the people’s government of the province, autonomous region or municipality directly under the Central Government may establish drug testing institutes within its respective administrative area. The plan for the establishment of local drug testing institutes shall be proposed by the drug 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 drug regulatory department under the State Council and the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government may, when necessary, designate any testing institute fulfilling the requirements for drug testing to undertake drug testing.
Chapter II
Control over Drug Manufacturers
Article 3 A Drug Manufacturing Certificate shall be acquired for 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 4 Any drug manufacturer that intends to alter the approved items in the Drug Manufacturing Certificate shall, 30 days prior to alteration of any approved items, apply to the original certificate-issuing authority for registration of alteration; no approved items may be altered without approval.
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