Reactions 1212 - 26 Jul 2008

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SFDA issues white paper on drug safety China’s State Food and Drug Administration (SFDA) has published a white paper outlining the status of drug supervision in China. Since 2002 China has had a nationwide information network for monitoring ADRs, making electronic reporting and online real-time reporting feasible. In 2007, the reporting rate for ADRs reached 400 per 1 million – a ratio approaching that of the developed countries. The SFDA believes this shows the considerable improvement in China’s monitoring and early-warning capabilities regarding ADRs. The SFDA, founded in 2003, is responsible for both administrative and technical supervision over the research, production, distribution and use of drugs and medical devices. The Chinese government has focused on establishing drug regulatory departments under central government leadership. By year-end 2007, China had 2692 drug regulatory departments, including 31 at the provincial level, 339 at the municipal (prefecture) level and 2321 at the county level. The government has continued its financial investment into drug safety supervision, with the emphasis on improving the drug safety testing level and ability, and providing technical support for the drug safety supervision work. Other key activities undertaken include: • implementing a market access system for drugs • developing a certification system for the quality control over drug research, manufacturing and distribution • establishing a drug classification system • and supervising traditional Chinese medicine and folk medicine. State Food and Drug Administration. Status quo of drug supervision in China. Internet Document : [14 pages], Jul 2008. Available from: URL: http:// 801075317 eng.sfda.gov.cn

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Reactions 26 Jul 2008 No. 1212