美国FDA复杂仿制药注册沟通交流制度研究及启示

FDA′s Complex Generic Drug Registration Communication System and Its Enlightenment

目的在药品审评审批制度改革提出提高仿制药质量、促进仿制药发展等要求的背景下,本研究探讨美国FDA复杂仿制药注册沟通交流制度,提出对我国药品注册沟通交流机制的建议。方法利用对比研究梳理美国FDA复杂仿制药注册沟通交流制度,包括复杂仿制药范围、沟通交流会议类型和会议要求等,进而分析我国药品注册沟通交流制度仍存在的不足。。结果我国药品注册沟通交流未基于各类药物研发特点和管理类别细化相应的适用范围以及会议要求等。结论结合现有药品注册沟通交流的管理要求,建议进一步细化沟通交流会议类别,补充完善沟通交流会议要求,明确复杂仿制药管理要求,指导规范仿制药企业注册申报,提高仿制药申报质量,切实满足高质量仿制药的临床需求。

OBJECTIVE Under the background of the requirements for improving the quality of generic drugs and promoting the development of generic drugs proposed by the reform of drug review and approval.To discuss FDA′s complex generic drug registration communication system and puts forward suggestions on the communication mechanism of drug registration in China.METHODS The paper introduces the FDA′s regulatory policies from the scope of complex generic drugs,the types of communication meetings and the relevant requirements of the meetings,and analyzes the scope of drug registration communication in China.RESULTS Use comparative research to outline FDA′s complex generic drug registration communication system,including the scope of complex generic drugs,the types of communication meetings and the relevant requirements,and then analyze the deficiencies of the drug registration communication system in China.CONCLUSION In combination with the existing management requirements for drug registration communication,it is suggested to further refine the categories of communication meetings,supplement and improve the requirements for communication meetings,clarify the management requirements for complex generic drugs,guide and standardize the generic drugs registration,improve the quality of generic drug application,and effectively meet the clinical needs of high-quality generic drugs.