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鄂政发[2016]36号各市、州、县人民政府,省政府各部门:为深入贯彻落实《国务院关于改革药品医疗器械审评审批制度的意见》(国发[2015]44号)精神,进一步提高我省药品医疗器械审评审批质效和服务水平,加快推动医药产业转型升级和创新发展,结合我省实际,提出以下实施意见。一、主要目标加强药品医疗器械审评审批体系建设,使我省审评审批能力和质量达到国内一流;推进仿制药质量和疗效一致性评价,力争2018年底前完成国家基本药物目录中的化学药品仿制药口服固体
E Zheng Fa [2016] No. 36 Municipal, State and County People’s Governments and Provincial Government Departments: In order to thoroughly implement the “Opinions of the State Council on Reforming the Examination and Approval System of Pharmaceutical and Medical Devices” (Guo Fa [2015] No. 44) To further improve the quality and service level of medical equipment review and approval in our province, accelerate the transformation and upgrading of the pharmaceutical industry and innovation and development, and put forward the following implementation suggestions in light of the reality of our province. I. MAIN OBJECTIVE To strengthen the review and approval system for the examination and approval of pharmaceuticals and medical devices so that the examination and approval capacity and quality of our province will reach the first-class in the country; promote the consistency assessment of the quality and efficacy of generic drugs and strive to complete the chemical products in the catalog of national essential medicines by the end of 2018 Generic oral solid