国外药品审评专家咨询制度在药品审评体系中的作用及思考

The Role and Consideration of Expert Consultation in Drug Evaluation System

目的:进一步促进我国药品审评专家咨询制度发挥其在药品注册申请审评体系中的作用。方法:通过介绍美国食品药品监督管理局(FDA)、欧洲药品管理局(EMA)及日本药品和医疗器械管理局(PDMA)对于药品审评专家咨询委员会(简称"专家咨询委员会")的管理、定位及日常工作程序设定,分析欧美日监管体系下专家咨询委员会在药品审评审批体系中发挥的作用,进一步探索我国药品审评专家咨询制度的发展方向。结果和结论:FDA、EMA和PMDA均具有完善的专家咨询委员会工作制度。其中,FDA的咨询委员会中包含消费者代表、行业代表和病人代表,涵盖面广,充分考虑到各方利益;EMA的科学咨询小组和PMDA的科学委员会则要求成员不能为监管部门成员。这些举措对提高专家咨询会公正性和工作透明度均具有借鉴意义。我国药品监管部门可以进一步完善药品审评专家咨询委员会工作制度,充分发挥专家咨询制度在专业审评阶段与综合审评阶段的咨询作用,在保护申请人商业秘密前提下,提高专家咨询会工作透明度,加强网络建设,将更有利于发挥药品专家委员会在药品审评体系中的作用。

Objective: To promote China’s drug evaluation expert consultation and to play its role in the drug registration application review system. Methods: By introducing the management, positioning and daily work procedures of the Expert Advisory Committee for drug registration review of the Food and Drug Administration(FDA), the European Medicines Agency(EMA) and Pharmaceutical and Medical Devices Administration(PMDA), analyzed the role of the expert advisory committee in the drug evaluation and approval system in the European, American and Japanese regulatory system, and further explored the development direction of the expert advisory system for drug evaluation in China. Results and Conclusion: FDA, EMA and PMDA all have a complete system of expert advisory committees. Among them, the FDA’s advisory committee includes consumer representatives, industry representatives, and patient representatives, covering a wide range of areas and fully considering the interests of all parties. The SAG of EMA and the scientific committees of PMDA require that members not serve in the regulatory agencies. These measures are of reference significance for improving the fairness and transparency of the expert consultation. Therefore, giving full play to the advisory role of the expert advisory system in the professional review stage and the comprehensive review stage,(National Medical Products Administration) NMPA can further improve the transparency of the work of the expert advisory committee and strengthen the network construction under the premise of protecting the commercial secrets of applicants, which will be more conducive to the role of the expert committee in the drug review system.