Experiences in Europe,United States,and Japan for the Key Issues on Certificate Holding and Product Manufacturing During the Implementation of China's Marketing Authorization Holder(MAH)System
The marketing authorization holder(MAH)may or may not be the same as the drug manufacturer.The separation between the holder and the manufacturer is one of the essential aspects of the MAH system.Under the previous regulatory system in China,the holder-manufacturer-in-one restriction was implemented,requiring the MAH to hold the certificate of a drug product.With the development of the pharmaceutical industry and regulatory science,issues such as duplicate construction of production facilities and insufficient definition and enforcement of responsibilities of the drug holder under the holder-manufacturer-in-one system have become increasingly critical.It is necessary to establish the MAH system to strengthen the responsibilities of the MAH and the separation between the holder and the manufacturer.This article focuses on the key issues of certificate holding and product manufacturing reflected by industry demand,especially the current regulatory approaches and industry expectations on cross-border certificate holding and product manufacturing under an MAH.It also examines the foreign MAH-delegated local agent and its roles and responsibilities,as well as the relationship among the MAH,drug substance holder,and drug substance manufacturer.The gaps between supervision and demand,as well as challenges,are analyzed.To explore the reference for the implementation of China's MAH system,this article compares key points,differences,and performance of various regulatory measures in Europe,United States,Japan and China.
marketing authorization holdermarketing authorizationmanufacturing authorizationcertificate holding and product manufacturing
万方数据
维普
