Forty years of changes and thinking on China’s drug regulation
- VernacularTitle:中国药品监管40年变迁与思考
- Author:
Ruilin SONG
1
,
2
;
Xinyi LI
3
;
Fan ZHANG
1
;
Yangyang ZHANG
1
;
Xiaoyu PEI
3
Author Information
1. China Pharmaceutical Innovation and Research Development Association，Beijing 100007，China
2. Research Center of National Drug Policy & Ecosystem，China Pharmaceutical University，Nanjing 211198，China
3. Regulatory Science Research Institute，China Pharmaceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
reform of drug regulation;
Drug Administration Law;
evaluation and approval system;
approval authority
- From:
China Pharmacy
2024;35(24):2965-2971
- CountryChina
- Language:Chinese
-
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.
