对药用辅料监管现状的几点思考

Pondering over Pharmaceutical Excipients Regulation

目的为建立符合我国制药行业发展的药用辅料监管方式提供参考。方法对我国药用辅料的标准收载情况、行业以及行政管理现状进行分析,在借鉴欧美国家药用辅料监管经验的基础上,提出相应的监管对策。结果与结论我国药用辅料行业存在法律法规体系缺失、质量标准不健全、行业准入门槛低、质量保证体系缺失等监管漏洞,建议通过建立健全相关法律法规、完善药用辅料备案档案(DMF)备案管理、实行第三方审计和建立制药企业辅料数据库等措施,加强我国药用辅料监管,确保药用辅料质量安全。

Objective To provide reference for pharmaceutical excipients regulation in accordance with the development of domestic pharmaceutical industry. Methods The current status of standard compilation, industry development and administration systems of pharmaceutical excipients were analyzed, corresponding countermeasures were offered on the basis of reference to experience of excipients regulation in European and American countries. Results and Conclusion The analysis revealed that there were still many loopholes existing in the pharmaceutical excipients industry, such as lack of laws and regulation systems, incomplete quality standards, a low entry-level, as well as lack of a quality assurance system. It is recommended to establish and improve relevant laws and regulations, improve DMF filing management, practice the third-party audit system and establish excipient database of pharmaceutical companies to strengthen the supervision of pharmaceutical excipients, and ensure quality and safety of pharmaceutical excipients.