境外药品上市许可持有人指定企业法人的管理模式研究

Research on administration mode of enterprise legal person designatedby overseas drug marketing authorization holders

在药品上市许可持有人制度全面实施的背景下,药品上市许可持有人需要对药品承担全生命周期管理责任。本研究旨在探索适合我国境外药品上市许可持有人的管理模式,通过对美欧日境外药品上市许可持有人的管理模式进行比较研究,明确境外持有人指定境内企业法人的资质要求、指定时间和形式、义务、责任,从而强化落实境外药品上市许可持有人全生命周期责任,对《药品管理法》实施层面提出具体的解决方案。

In the context of the comprehensive implementation of the drug marketing authorization holder system,the drug marketing authorization holder needs to assume the responsibility for the whole life cycle of drugs.This study aims to explore the administration mode suitable for drug marketing authorization holders from outside,and through a comparative study of the mode of overseas drug marketing authorization holders in the United States,EU,and Japan,clarify the qualification requirements,time and form of appointment of agent,obligations and responsibilities of the domestic enterprise legal person designated by the overseas holder,thereby strengthening the implementation of the full life cycle responsibility of overseas drug marketing authorization holders and putting forward specific solutions for the implementation of the Drug Administration Law.