Experience of Quality Supervision of Pharmaceutical Production in International Clinical Trial
10.3969/j.issn.1008-049X.2018.03.031
- VernacularTitle:国际临床试验用药品生产质量监管经验借鉴
- Author:
Zhanquan WEN
1
;
Yuan BI
;
Yanzhao ZHANG
;
Chuanxu LIU
;
Changying CAO
;
Xiaoqing JIANG
Author Information
1. 北京中医药大学管理学院 北京100029
- Keywords:
Clinical trial;
Drug;
Production quality;
International experience
- From:
China Pharmacist
2018;21(3):474-476,489
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To put forward relevant policy recommendations for strengthening the quality control of clinical trial drug production in China. Methods:The objective differences of clinical trials and marketing drugs in the production and management as-pects were in-depth analyzed, and the lessons in clinical trial drug production quality supervision and management experience were drawn from the FDA and the European Union EMA. Results and Conclusion:Based on the particularity of clinical trial drug produc-tion management,it is suggested to formulate the administrative rules and technical standards for the quality control of clinical trial drug production and amend relevant laws and regulations timely so as to achieve the purpose of strengthening the quality supervision of drug production in clinical trials.
