State Food and Drug Administration, Provisions for the Administration of Record Filing Regarding the Acceptance of Entrustment of Pharmaceutical Processing from Overseas Pharmaceutical Manufacturers

Promulgated: November 15 2005
Effective: January 1 2006
Applicability: The term "acceptance of entrustment of pharmaceutical processing from overseas pharmaceutical manufacturers" refers to domestic pharmaceutical production enterprises' acceptance of the entrustment of pharmaceutical processing from overseas pharmaceutical manufacturers, where such processed pharmaceuticals may not be sold or used within China (Article 2). These Provisions apply to acceptance of entrustment of pharmaceutical processing from pharmaceutical manufacturers in Hong Kong, Macao and Taiwan (Article 12).

Main contents: The entrusting party of pharmaceutical processing shall be a pharmaceutical manufacturer who holds the permit for overseas listing of the concerned pharmaceuticals to be processed or the sales permit thereof, or its entrusted agent. The entrusted party shall be a domestic pharmaceutical production enterprise that holds the Certificate of Good Manufacturing Practices for Pharmaceutical Products commensurate with the production conditions for the pharmaceuticals to be processed (Article 3). The entrusted pharmaceutical production enterprise shall, within 30 days of signing the processing contract, file for the record with the food and drug administration of the province, autonomous region or municipality directly under the central government where it is located (Article 7). Acceptance of entrustment of the processing of vaccine products, blood products and other pharmaceutical products specified by the State Food and Drug Administration from overseas pharmaceutical manufacturers shall not be allowed (Article 9).
Related legislation: Measures for the Regulation of Pharmaceutical Production