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译者注:对已上市药品开展上市后评价是实现药品全生命周期监管的重要手段。近年来,发达国家监管机构不断加强药品注册审批管理,新上市药品的证据要求不断加强。但与之相对应,上市多年的药品或由于原有的证据基础薄弱,或因为相关医药学认识的改变,其原有确定疗效不断受到新的质疑。同时,药品研发新技术不断出现,相关经验的不足也使药品监管部门在注册审批阶段对药品的认识存在潜在的不确定性。随着风险管理
Translator’s Note: After the listing of listed drugs to carry out post-market evaluation is to achieve an important means of monitoring the entire life cycle of drugs. In recent years, the regulatory authorities in developed countries have continuously strengthened the examination and approval of drug registration and the evidence requirements for newly listed drugs have been continuously strengthened. However, correspondingly, the listed drugs that have been on the market for many years are still subject to new questions due to the weak foundation of the original evidence or the change of the related medical knowledge. At the same time, new technologies for drug research and development continue to emerge, and the lack of relevant experience also makes the drug regulatory authorities have potential uncertainties about the understanding of pharmaceuticals during the examination and approval phase. With risk management