The influence and cohesion suggestions of the MAH system on the current regulatory systems
10.3969/j.issn.1674-2982.2018.12.001
- VernacularTitle: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
- Author:
Jin-Ping XIE
1
;
Yuan-Yuan SUN
;
Nan PENG
;
Rong SHAO
Author Information
1. 中国药科大学国家药物政策与医药产业经济研究中心 江苏南京 211198
- Keywords:
MAH system;
Technology transfer;
Sub-contract production;
Pharmacovigilance
- From:
Chinese Journal of Health Policy
2018;11(12):1-6
- CountryChina
- Language:Chinese
-
Abstract:
Objectives:This research specifically reviews the pharmaceuticalproduct life-cycle managementreg-ulatory 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.
