title: [Introduction of U.S. FDA mini-sentinel program].
abstract: In China, all of traditional Chinese medicine injections should pass clinical trials I, II and III for their safety and effectiveness before coming into the market. However, these clinical tests are mostly restricted to standard treatment for specific groups, and conducted in strict accordance with clinical trial protocols. In the real world, as there are more changes in the post-market clinical application of traditional Chinese medicine injections than in the experiment environment, regulatory bodies set stricter requirements for the post-market re-assessment on traditional Chinese medicine injections. Early-stage studies could only provide the most fundamental and restricted data of efficacy and safety of traditional Chinese medicine injections. In this essay, mini-sentinel program of U. S. FDA is introduced in order to provide reference for large-sample-size post-market clinical safety monitoring studies for traditional Chinese medicine injections.
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. zhinanb2012@yahoo.com.cn
authors.forename: Yan-Ming
authors.initials: YM
authors.lastname: Xie
authors.forename: Xing
authors.initials: X
authors.lastname: Liao
authors.forename: Hao
authors.initials: H
authors.lastname: Shen
mesh_terms: D003628:Database Management Systems; D062313:Databases, Pharmaceutical; D006040:Goals; D008516:Medicine, Chinese Traditional; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration