China Seeks to Strengthen Regulatory Supervision of Drug Manufacturers

China's State Food and Drug Administration (SFDA, Beijing, China, www.sfda.gov.cn/eng/)issued a notice on May 18, 2006 requiring drug regulatory departmentsof provinces, autonomous regions, and municipalities to furtherstrengthen the supervision and management of drug manufacturers.

The action follows reports of several deaths and injuries attributed toa substandard ingredient used in armillarisin A, a drug to treat gallbladder, liver, and gastric disorders (http://english.gov.cn/2006-05/15/content_280384.htm).

The SFDA states that "drug regulatory departments at all levels shallattach great importance to the routine supervision and management ofdrug manufacturers [and] implement the supervision responsibility inreal earnest and effectively ensure the quality of drug production."

To meet these goals, SFDA outlined several requirements for drugregulatory departments. These include:

• intensify routine supervision according to the requirementsof the Drug Administration Law of the People's Republic of Chinaand Provisions for the Supervision of Drug Manufacturing;

• urge drug manufacturers to improve product quality assurancesystems according to good manufacturing practices (GMPs);

• immediately organize the audit of suppliers of raw materials andexcipients of drug manufacture;

• organize an all-round checkup of the procurement and qualitytesting of bought raw materials and excipients, material management,and product examination and release.

The notice further directs drug regulatory departments to intensify thesupervision and inspection efforts on drug manufacturers after GMPcertification, continue with follow-up inspections and unannounced GMPinspections, and attach importance to the examination of manufacturers'newly approved products after GMP certification.

China's SFDA also announced in May it had formulated interimrequirements for unannounced GMP inspections for human drugs inaccordance with the Drug Administration Law of the People's Republic ofChina and other regulations to standardize unannounced GMP inspections.

"The requirements point out that the unannounced GMP inspection forhuman drugs is a type of GMP follow-up inspection and refer to on-siteinspection to pharmaceutical manufacturers carried out by drugregulatory departments at any time when necessary," said the SFDA in arelease.