国外药品生产企业分类分级监管的思考

Thoughts on the Classification and Grading Supervision of Foreign Pharmaceutical Manufacturing Enterprises

目的:探讨加强对药品生产企业进行分类分级监管的方法。方法:收集多个国家药品监管机构对药品生产企业进行分类分级监管的相关法规,总结值得我国药品监管部门借鉴的经验。结果与结论:国际药品监管机构通常运用风险评估工具研判药品生产企业存在的风险,从而实施相应的检查计划。建议我国参照相关做法建立风险分析模型,根据分析结果确定检查频次,建立统一的动态监管数据库,合理分配检查资源,提高监管效率,促进医药产业发展。

Objective: To explore ways to strengthen the classification and grading supervision of pharmaceutical manufacturing enterprises. Methods: The relevant laws and regulations for the classification and grading of drug manufacturing enterprises made by the drug regulatory agencies in many countries were collected, and the experience worthy of references for Chinese drug regulatory agencies was summarized. Results and Conclusion: International drug regulatory agencies usually use risk analysis tools to judge the risks existed in the drug manufacturers, so as to implement corresponding inspection plans. It is suggested that China should establish risk analysis models according to relevant practices, determine the inspection frequency according to the analysis results, establish the unified dynamic supervision database, reasonably allocate inspection resources, improve supervision efficiency, and promote the development of the pharmaceutical industry as well.