[Research on foreign countries laws and regulations on surveillance and reporting of postmarketing drugs adverse reactions].
Following more and more new drugs are authorized into market, new, serious or unexpected adverse drug reactions appear frequently, which is a serious threat to people health and life. Through making laws and guidelines, governments of various countries aim to strengthen and standardize the surveillance and reporting of postmarketing drugs. The drugs management department of our country are doing related jobs positively, but there are some problems, such as drug risk-menagement is not emphasized well, and the management department lacks clarity on operating related regulations. This article tries to explore foreign countries' laws and regulations on the surveillance and reporting of postmarketing drugs, aiming to provide reference for our courtry.
Tian
Feng
F
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700.
Xie
Yanming
Y
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D002681:China; D006801:Humans; D038622:Internationality / Q000331:legislation & jurisprudence*; D007880:Legislation, Drug; D008389:Marketing of Health Services