美國的新藥審查制度與上市後安全性問題【醫事綜探】 試閱
New Drug Review System and Postmarket Safety Issues in the U.S.
根據《美國醫學會雜誌》今（2017）年發表的研究指出，2001∼2010年間受美國食品藥物管理局核可的藥物中，約有三分之一在上市後出現安全問題。美國自1990年代起即持續致力於加快藥物審查的速度，但也引發部分專家憂心對上市後的安全性造成影響。新藥的審查如何在速度與安全性之間取得平衡始終是一大難題，無論如何，此研究結果讓人引以為誡，即對任何上市後的新藥仍需持續監測。
According to a recent study published in the Journal of the American Medical Association (JAMA), about a third of the drugs the Food and Drug Administration (FDA) approved between 2001 and 2010 were involved in some kind of safety event after reaching the market. Since 1990s, FDA has been managing to accelerate the speed of new drug review, but many experts worry that the frequency of postmarket safety problems would increase with faster approval. The balance between review speed and drug safety has always been a difficult subject. We should all keep in mind that it is crucial for continuous monitoring of the safety of drugs throughout their life cycle.
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