State Council, PRC Law on the Administration of Pharmaceuticals Implementing Regulations

Promulgated: August 4 2002
Effective: September 15 2002

Revised on April 24, 2015. Latest revision can be found at:

http://www.chinalawandpractice.com/Article/3451467/PRC-Law-on-the-Administration-of-Pharmaceuticals-2nd-Revision.html

Main contents: The Regulations contain ten parts, including parts on the administration of pharmaceutical producers (Part Two), the administration of pharmaceutical distributors (Part Three), pharmaceutical production (Part Five), packaging (Part Six), and pricing and advertisement (Part Seven).
Article 2 requires that the pharmaceutical regulatory departments of the people's government of provinces, autonomous regions and municipalities directly under the central government establish pharmaceutical inspection agencies. Parts Two and Three lay down the application procedures for establishing a pharmaceutical production enterprise, a pharmaceutical wholesaling enterprise or a pharmaceutical retail enterprise. Pharmaceutical Production Permits and Pharmaceutical Business Permits are valid for five years (Article 8).
Article 30 states that testing of new products on patients must be approved by the State Council pharmaceutical regulatory department. Article 36 provides that imported pharmaceutical products should have been authorized for distribution at the country/region of origin. In the event that a product has not been approved for distribution in the country/region of origin, it may be approved for importation after the State Council pharmaceutical regulatory department has confirmed it to be safe, effective and clinically essential. Imported pharmaceuticals must be registered in accordance with provisions.
Related legislation: PRC,Law on the Administration of Pharmaceuticals (Revised), Feb 28 2001, CLP 2001 No.3 p24; Administration of Pharmaceutical Production Quality Guidelines (1998 Revision), Jun 18 1998, CLP 1998 No.9 p21 and Pharmaceutical Business Quality Control Standards, Apr 30 2000, CLP 2000 No.5 p10; Non-clinical Research of Pharmaceuticals Quality Control Guidelines; Clinical Trials for Pharmaceuticals Quality Control Guidelines; PRC, Pricing Law, Dec 29 1997, CLP 1998 No.2 p51 and PRC, Advertising Law, Oct 27 1994, CLP 1994 No.10 p19