中外药品应急审批制度对比研究

Comparative study on pharmaceutical emergency approval systems in China and other countries

目的通过对比中外药品应急审批制度,探讨进一步优化我国药品应急审批制度的思路和措施。方法分析我国药品应急审批制度现状,并与美国、欧盟、日本的相关制度对比。结果国外药品应急审批目标定位明确,以临床需求为目的,加快临床急需药品的审评上市,形成覆盖全流程的多通道、多模式、多机制优先审评体系,法规体系层次清晰、完整,可操作性强。我国相应的审批制度起步较晚,处于不断完善的阶段,在制度建设、政府职能、人员优化、上市后监管等方面有待改进。结论我国药监部门应总结既往工作经验,借鉴国外一些可行的审批模式和监管方式,进一步改善药品应急审批制度体系与流程,提升药品审批效率以及应对突发事件的药品保障能力。

Objective To explore the ideas and measures to further optimize China’s drug emergency approval system by comparing the drug emergency approval systems in China and other countries.Methods The current situation of China’s drug emergency approval system was analyzed and compared with the relevant systems of the United States,the European Union and Japan.Results The goal of drug emergency approval in other countries is clearly positioned to accelerate the review and listing of urgently needed clinical drugs for the purpose of clinical needs,forming a multi-channel,multi-mode and multi-mechanism priority review system covering the whole process,and the regulatory system is clear,complete,and operable.The corresponding approval system in China started late and is in the stage of continuous improvement,which needs to be improved in terms of system construction,government functions,personnel optimization,and post-market supervision.Conclusion Drug regulatory authorities in China should summarize their past work experience and draw on some feasible approval models and regulatory approaches in foreign countries,further improve the system and process of the drug emergency approval system and enhance the efficiency of drug approval and the ability to protect drugs in response to emergencies.