The State Food and Drug Administration (SFDA) issued in late 2004 the Interim Provisions for Drug Safety Credit Classification. The new regulation will categorize domestic and foreign drug companies, including manufactures, distributors, and research and development (R&D) units, into four credit levels based on their compliance with current pharmaceutical laws and regulations.
SFDA will also soon begin a “National Pharmaceutical Standard Upgrade Initiative” which aims to clean up drug products approved previously with unreliable national pharmaceutical manufacturing standards. The Initiative targets more than 4,000 traditional Chinese medicine products and 500 pharmaceutical chemical products, and is expected to last five years.
In a separate development, SFDA revealed in late 2004 that future GMP requirements for IVD reagents, medicinal gases and Chinese medicinal materials. Manufacturers of IVD reagents (administered as drugs) will need to meet GMP standards by