新修订《药品管理法》诠释“最严厉的处罚”——通过经典案例探讨药企合规风险防范

Interpretation of the“Toughest Penalty”in the Latest Amended Drug Administration Law--Discussion of Compliance Risk Prevention for Pharmaceutical Enterprises Based on Case Study

鉴于新修订《药品管理法》大幅提高了处罚力度,本文选取了近年来较为典型的处罚案例,从实践方面看待新修订《药品管理法》中“最严厉的处罚”,并结合近期的热点合规案件,为企业在新修订《药品管理法》下的合规模式给出建议。

Since the scope and intensity of penalties have been significantly increased in the latest amended Drug Administration Law,this paper selected the typical cases of penalties in recent years,and looked at the"toughest penalties"in the latest amended Drug Administration Law from the practical perspective.Combined with the recent hot compliance cases,this paper gave some suggestions for the compliance mode of enterprises under the latest amended Drug Administration Law.