药品上市许可持有人(MAH)制度对现行监管制度的影响及衔接建议

The influence and cohesion suggestions of the MAH system on the current regulatory systems

目的:梳理药品全生命周期管理中与药品上市许可持有人制度(Marketing authorization holder,MAH)密切相关的配套监管制度,理清MAH制度推行前后对上述监管制度产生的影响,并提出针对性的衔接建议,为全面推行MAH制度提供参考。方法:通过文献研究法、制度比较法,对MAH制度实施前后与之密切相关的配套监管制度的变化要点进行详细地梳理比较。结果:MAH制度的推行将给药品技术转让制度、药品委托生产制度、药品经营许可制度、药品不良反应监测与药物警戒制度、药品损害责任制度等配套监管制度带来较大变化和影响。结论:为推进MAH制度的落地,应加快修订《药品管理法》并及时修订与药品上市许可持有人制度相关的配套药品监管制度,以简化持有人产权变更及场地变更程序,落实持有人开展药物警戒的主体责任,全面保障药品的质量和患者合法权益。

Objectives: This research specifically reviews the pharmaceuticalproduct life-cycle managementregulatory systems closely related to the Marketing Authorization Holder(MAH) systemin the whole cycle management of drugs toidentifyits impact on these regulatory systems before and after its implementation,to propose targeted cohesion recommendations and provide references on the comprehensive implementation of the system itself.Methods: Through the literature research and system comparison methods, the changes in the supporting regulatory systemsclosely related to the MAH systemintroducedbefore and after its implementation were detailed and compared. Results:The MAH system implementationbrought remarkablechanges and impacts on the technology transfer system, drug entrusted introduction system,the original equipment manufacturing system, the business license system, the adverse reaction monitoring and evaluation system and the damage liabilitysystem of pharmaceutical products as well. Conclusions: In order to promote the MAH system implementation, policy makers should amend the Drug Administration Law and revise relevant regulations tosimplify theproperty rights and site change procedures.This paper also suggests putting in place the main responsibility of the individual to carry outpharmacovigilance concerning MAH to fully guarantee the drug quality and legitimatizethepatients rights and interests.