目的：新修订的《药品管理法》引入了国际通行的药品监管理念并吸纳了近几年来药品审评审批制度改革的成果，这些新变化给药品监管工作带来了新的挑战。本文旨在通过对新变化中出现的典型问题进行分析，提出可行的应对举措和建议，推动药品监管模式创新。方法：针对目前药品监管中的实际问题和预期风险，将新修订的《药品管理法》中的新变化、新要求与ICH相应指导原则中的相关理念、技术要求进行对照分析，并结合上海市药品审评审批改革中积累的相关试点经验进行探讨。结果与结论：药品监管部门以药品上市许可持有人制度为切入点，探索建立以品种为主线的全链条监管新模式，落实新修订《药品管理法》中的监管要求，实现对药品的全生命周期监管。
Abstract
Objective: The newly revised Drug Administration Law has introduced the internationally accepted concept of drug regulation and incorporated the results of the reform of the drug review and approval system in recent years, which have brought new problems and challenges to drug regulation. The purpose of this paper is to analyze the typical problems emerging from the new changes, put forward feasible measures and suggestions, and provide practical countermeasures for the mechanism innovation of drug regulation. Methods: In view of the actual problems and expected risks in the current drug regulation, the new changes and new requirements in the newly revised Drug Administration Law are compared with the relevant concepts and technical requirements in the corresponding ICH guidelines, and the relevant pilot experience accumulated in the reform of drug review and approval in Shanghai is discussed. Results and Conclusion: The drug regulatory department takes Market Authorization Holder (MAH) as the starting point, explores the establishment of a new mechanism of whole-chain supervision with drug product, implements the regulatory requirements in the newly revised Drug Administration Law, and realizes the overall supervision of drug products.
关键词
药品管理法;ICH指导原则;药品上市许可持有人制度;药品全生命周期监管
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Key words
the Drug Administration Law;ICH guidelines;Market Authorization Holder (MAH);drug lifecycle regulation
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中图分类号：
R95
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