Experience of Quality Supervision of Pharmaceutical Production in International Clinical Trial / 中国药师

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.