Consideration of compliance review of pharmaceutical development institutions based on the problems found in drug inspection
10.13699/j.cnki.1001-6821.2024.03.035
- VernacularTitle:结合药品注册核查发现问题对研制单位合规审查的考虑
- Author:
Yuan LI
1
;
Yan FEI
;
Gang ZHOU
Author Information
1. 国家药品监督管理局药品审评中心,北京 100076
- Keywords:
drug inspection;
pharmaceutical research;
compliance;
risk assessment
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(3):477-480
- CountryChina
- Language:Chinese
-
Abstract:
The compliance of drug development and production directly affects the safety,effectiveness and quality control of drugs.In this paper,the situation of on-site inspection of pharmaceutical development in recent years was summarized,the common problems found in on-site inspection were analyzed in detail,and the ideas of compliance review were discussed in combination with typical cases,in order to provide references for research units to further improve the quality of pharmaceutical research and strengthen the quality management of pharmaceutical research.
