The implementation of the newly revised Drug Administration Law comprehensively incorporates the system of marketing authorization holder(MAH)and positions it as a foundational and central element within the framework of the law.This article systematically examines the rights,proactive responsibilities,and passive obligations enjoyed and assumed by MAH and relevant entities throughout the entire pharmaceutical lifecycle.Using drug contract manufacturing as an illustrative case,it scrutinizes the implementation of responsibilities and obligations by MAH and relevant entities.The aim is to provide guidance for clarifying primary responsibilities and fulfilling relevant obligations,ensuring the quality and safety of pharmaceuticals.
关键词
药品上市许可持有人/相关主体/主体责任/责权利分析/委托生产
Key words
marketing authorization holder/relevant entities/main responsibility/analysis of responsibilities and rights/contract production of drugs
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