State Drug Administration, Production and Supervision of Pharmaceuticals Administrative Measures (Trial Implementation)

Promulgated: December 11 2002
Effective: February 1 2003

Main contents: Part Two of the Measures specifies the application, examination and approval Measures for establishment of a pharmaceutical production enterprise. Drug production enterprises may not share production or testing facilities (Article 10). Part Three concerns drug production permits. Permits are valid for five years (Article 13). Permit holders are subject to annual inspections (Article 16). Part Four deals with the supervision of outside processing. The delegating enterprise must have obtained the authorization number for the product, while the processing enterprise must possess a corresponding Drug Production Permit and Drug GMP Certificate (Articles 25 and 26). The delegating enterprise shall be responsible for product quality and sale (Article 27). The two parties shall conclude a contract stipulating technical, quality and other responsibilities (Article 28). The delegating enterprise then submits an application for outside processing to a competent drug administration, which forwards the application to the State Drug Administration (Article 29). Part Five concerns inspection and infractions.
Related legislation: PRC Administration of Pharmaceuticals Law (Revised), Feb 28 2001, CLP 2001 No.3 p14 and PRC Administration of Pharmaceuticals Law Implementing Regulations, Aug 4 2002, CLP 2002 No.8 p14