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中国药品监管40年变迁与思考
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| 篇名： | 中国药品监管40年变迁与思考 |
| TITLE： | Forty years of changes and thinking on China’s drug regulation |
| 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： | Since 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. |
| 期刊： | 2024年第35卷第24期 |
| 作者： | 宋瑞霖；李心怡；张帆；张洋洋；裴晓雨 |
| AUTHORS： | SONG Ruilin，LI Xinyi，ZHANG Fan，ZHANG Yangyang，PEI Xiaoyu |
| 关键字： | 药品监管改革；药品管理法；审评审批制度；审批权 |
| KEYWORDS： | reform of drug regulation； Drug Administration Law； evaluation and approval system； approval authority |
| 阅读数： | 3 次 |
| 本月下载数： | 0 次 |
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