基于某市药品上市许可持有人制度下委托生产的质量监督风险及监管服务策略研究  

Research on Quality Supervision Risks and Regulatory Service Strategies under the Drug Marketing Authorization Holder System

作　　者：周浩泽 姜莉 王军君 毛安敏 ZHOU Hao-ze;JIANG Li;WANG Jun-jun;MAO An-min(Nanjing Inspection Branch of Jiangsu Medical Products Administration;Center for Inspection of JSMPA)

机构地区：[1]江苏省药品监督管理局南京检查分局 [2]江苏省药品监督管理局审核查验中心

出　　处：《中国食品药品监管》2025年第2期128-135,共8页China Food & Drug Administration Magazine

摘　　要：药品上市许可持有人(MAH)制度优化了资源配置,加快了新药上市进程,极大促进了医药产业发展。近年来,南京市委托生产MAH数量激增,给药品监管带来了新挑战。本文通过信息收集、监督检查、走访座谈、法规考核等多种方式就南京市MAH企业委托生产情况进行了调研,对当前MAH制度下委托生产为企业及药品监管部门带来的质量风险及挑战进行探讨,提出了对于进一步做好药品委托生产监管及服务的思考,以期完善日常监管和产业服务策略,进一步规范药品委托生产行为。The Marketing Authorization Holder(MAH)system has optimized resource allocation,accelerated the listing process for new drugs,and greatly promoted the development of the biomedical industry.In recent years,the number of MAH enterprises engaging in contract manufacturing in Nanjing has soared,presenting new challenges for drug supervision.This article undertakes an in-depth analysis of the contract manufacturing practices of MAH enterprises in Nanjing through information gathering,supervision and inspection,field visits,discussions,and regulatory evaluations.It examines the quality risks and challenges posed by contract manufacturing under the current MAH system from both the enterprise and regulatory perspectives.Furthermore,the article proposes recommendations to enhance the supervision and service of drug contract manufacturing.The ultimate goal is to optimize daily supervision and industrial service strategies and further standardize drug contract manufacturing practices.

关 键 词：药品上市许可持有人 委托生产 质量监督风险 监管服务策略 

分 类 号：R95[医药卫生—药学]