An Overview of Adverse Drug Reaction Monitoring in China
Tóm tắt
China’s National Center for Adverse Drug Reaction (ADR) Monitoring was established in 1989. In 1998, nearly a decade later, China joined the World Health Organization’s (WHO) Programme for International Drug Monitoring. During March 2004, China formally promulgated the final version of the Regulations on Adverse Drug Reaction Reporting and Monitoring. This modern system supplements an informal reporting system in scholarly publications that dates back to ancient times. Procedurally, the formal Chinese monitoring system requires pharmaceutical industry and healthcare professionals to report most ADR events quarterly. However, new, uncommon, serious or ‘group’ ADRs are required to be reported within a shorter time period. Reports will be made to local centres, which then analyse and transmit them to a national ADR centre operated by China’s State Food and Drug Administration (SFDA). The national authority is then empowered to authorise further studies, publish formal warning announcements or prohibit use of a product. Traditional Chinese medicine (TCM) products are also regulated as drugs in China. Because TCM product use is greatly increasing worldwide, Chinese ADR monitoring is particularly, if not uniquely, useful in its reporting of TCM-related ADRs. A survey of Chinese ADR alerts and findings regarding TCMs and other substances is included, providing an overview of the breadth and timeliness of the information available from China’s increasing pharmacovigilance. Overall, the system shows considerable progress and promise, especially if ADR reporting procedure awareness continues to grow among China’s healthcare professionals and public.
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