中国食品药品监管Issue(2)：128-135,8.DOI:10.3969/j.issn.1673-5390.2025.02.013
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
周浩泽 1姜莉 1王军君 1毛安敏2
作者信息
- 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
- 折叠
摘要
Abstract
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Key words
drug marketing authorization holder/contract manufacturing/quality supervision risks/regulatory service strategies分类
医药卫生引用本文复制引用
周浩泽,姜莉,王军君,毛安敏..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[J].中国食品药品监管,2025,(2):128-135,8.
