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中欧卫生管理与政策中心主任蔡江南:去年以来,关于药品的注册、审批和知识产权方面,国家频频出台重要政策。2015年7月22日国家食品药品监督管理总局发布的《关于开展药物临床试验数据自查核查工作的公告》(2015年第117号)号称“史上最严的数据核查要求”;2015年8月国务院出台了《关于改革药品医疗器械审评审批制度的意见》,提出审批提速、开展仿制药质量一致性评价等工作;2015年年底,全国人大会议表决通过了《关于授权国务院在部分地方
Cai Jiangnan, Director, Central European Center for Health Management and Policy: Since last year, important policies have been promulgated by the state on the registration, approval and intellectual property of pharmaceutical products. July 22, 2015 Announcement on Carrying Out Self-examination and Verification of Drug Clinical Trial Data (No. 117 of 2015) issued by the State Food and Drug Administration It is said that “the most stringent data verification requirements in history” 2015 In August, the State Council promulgated the Opinions on Reforming and Reviewing the Examination and Approval System of Medical Devices for Medical Devices, put forward the examination and approval of speeding up and carried out work on the consistency assessment of generic drugs. At the end of 2015, the National People’s Congress voted to pass the resolution on authorizing the State Council in some places