中国食品药品监管Issue(12)：84-93,10.DOI:10.3969/j.issn.1673-5390.2025.12.009
以多元检查筑牢药品生产安全防线
Strengthening Drug Production Safety Through Diversified Inspections:On the Core Role of Inspection Classification and GMP Compliance Inspections
YANG Xu-yun 1ZHAI Tie-wei 2LI Lu 3HU Zeng-yao3
作者信息
- 1. Tianjin Medical Products Administration
- 2. Center for Food and Drug Inspection of NMPA
- 3. National Medical Products Administration
- 折叠
摘要
Abstract
As one of the key technical instruments of pharmaceutical regulation,drug inspection spans the entire life cycle of medicinal products and plays a critical role in preventing potential risks,combating violations,promoting regulatory compliance within,advancing the pharmaceutical industry,and safeguarding public medication safety.With the ongoing reform of China's pharmaceutical regulatory system,a diversified inspection framework has been established and is gradually evolving toward digitalization and internationalization.This paper reviews the types and development history of drug inspections in China,analyzes inspection categories,their interrelationships,and new inspection modes based on the Drug Administration Law of the People's Republic of China and related regulations,and further proposes regulatory suggestions including strengthening GMP compliance inspections and integrating inspection types,so as to provide references for enhancing the institutionalization and standardization of inspection practices.关键词
药品/药品监管/药品检查/检查分类/药品GMP符合性检查Key words
drug/pharmaceutical regulation/drug inspection/inspections classification/GMP compliance inspection分类
医药卫生引用本文复制引用
YANG Xu-yun,ZHAI Tie-wei,LI Lu,HU Zeng-yao..以多元检查筑牢药品生产安全防线[J].中国食品药品监管,2025,(12):84-93,10.
