《中国中医药报》2017年10月11日讯:近日,中共中央办公厅、国务院办公厅印发了《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》,明确支持中药传承和创新,建立完善符合中药特点的注册管理制度和技术评价体系。《意见》在改革临床试验管理、加快审评审批、促进药品创新和仿制药发展、加强药品医疗器械全生命周期管理、提升技术支撑能力等方面,对深化药品医疗器械审评审批改革做出一系列制度性安排。在改革临床试验管理方面,《意见》提出临床试验机构资格认定实行备案管理、支持临床试验 Recently, the General Office of the CPC Central Committee and the General Office of the State Council printed the Opinions on Deepening the Innovation of Examination and Approval System for Drugs, Encouraging the Innovation of Medical Devices for Medical Devices, clearly supporting the inheritance and innovation of traditional Chinese medicine, Establish and perfect the registration management system and technical evaluation system in line with the characteristics of traditional Chinese medicine. The Opinions set out to reform the examination and approval system for deepening the review and approval of medical devices in terms of reforming the management of clinical trials, expediting examination and approval, accelerating the development of drug innovation and generic drugs, strengthening the management of the life cycle of pharmaceutical medical devices, and enhancing the technical support capabilities Series of institutional arrangements. In the reform of clinical trial management, “Opinions” put forward the clinical trial agency qualification record management, support clinical trials