Forty years of changes and thinking on China’s drug regulation

SONG Ruilin; LI Xinyi; ZHANG Fan; ZHANG Yangyang; PEI Xiaoyu

doi:10.6039/j.issn.1001-0408.2024.24.01

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Forty years of changes and thinking on China’s drug regulation

更新时间：2025-09-24

- Forty years of changes and thinking on China’s drug regulation
- ZHONGGUO YAOFANG Vol. 35, Issue 24, Pages: 2965-2971(2024)
- 作者机构：
  
  1.中国医药创新促进会，北京　100007
  2.中国药科大学国家药物政策与产业经济研究中心，南京　211198
  3.中国药科大学监管科学研究院，南京　211198
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.24.01
  CLC： R95
- Received：09 October 2024，
  
  Revised：2024-11-28，
  
  Accepted：06 December 2024，
  
  Published：30 December 2024
- 稿件说明：
移动端阅览
宋瑞霖,李心怡,张帆,等.中国药品监管40年变迁与思考[J].中国药房,2024,35(24):2965-2971.

SONG Ruilin,LI Xinyi,ZHANG Fan,et al.Forty years of changes and thinking on China’s drug regulation[J].ZHONGGUO YAOFANG,2024,35(24):2965-2971.
宋瑞霖,李心怡,张帆,等.中国药品监管40年变迁与思考[J].中国药房,2024,35(24):2965-2971. DOI： 10.6039/j.issn.1001-0408.2024.24.01.

SONG Ruilin,LI Xinyi,ZHANG Fan,et al.Forty years of changes and thinking on China’s drug regulation[J].ZHONGGUO YAOFANG,2024,35(24):2965-2971. DOI： 10.6039/j.issn.1001-0408.2024.24.01.

摘要

自1984年第一部《药品管理法》颁布至今，我国药品监管已经走过40年历程。40年来，我国药品监管体系逐步从粗放走向精细，监管理念也日趋科学化。本文阐述了新中国成立以来我国药品监管法规制度改革的历史沿革，重点还原了从1984年到2001年期间《药品管理法》修订的历史渊源；梳理了随着产业创新发展不断出现的药品监管新挑战以及我国药品审评审批制度随之做出的相应改革措施，归纳了药品监管的改革成效；通过研究分析产业国际化背景下我国药品监管在监管能力、监管资源以及监管体系等方面仍面临的挑战，提出了建立跨区域监管体制、改革审评机制、加强审评队伍建设以及提升监管透明度等以促进医药产业高质量发展的政策建议。

Abstract

ince the first

Drug Administration Law

was issued in 1984， the drug

regulation of China has undergone a forty-year process. During these four decades， China’s drug regulatory system has gradually transitioned from being extensive to refined， and the concept of supervision has become increasingly scientific. This paper first outlines the historical evolution of China’s drug regulatory laws and regulations since the founding of the People’s Republic of China， with a focus on the historical origins of the revision of the

Drug Administration Law

during 1984-2001. It also clarifies the new challenges faced by drug regulation as the industry innovates and develops， as well as the corresponding reform of the drug review and approval system. The paper summarizes the reform achievements of drug regulation. By studying and analyzing the challenges faced by drug regulation in terms of regulatory capacity， regulatory resources， and regulatory system in the context of internationalization of the industry， the paper proposes policy suggestions such as establishing a cross-regional regulatory system， reforming the review mechanism， strengthening the construction of the review team， and enhancing transparency in regulatory practices， with the aim of promoting the high-quality development of the pharmaceutical industry.

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