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2015年7月22日,国家食品药品监督管理总局发布了《关于开展药物临床试验数据自查核查工作的公告》,全面启动药物临床试验数据自查核查工作,为药品医疗器械审评审批制度改革拉开了序幕。今年7月21日,总局食品药品审核查验中心发布的《药物临床试验数据核查阶段性报告》(2015年7月~2017年6月)彰显了改革的初步成绩。改革之路无坦途,两年间,面对新旧观念的碰撞激荡、不同利益的摩擦抵牾、各种诉求的角逐博弈,食品药品监管部门为了让人民吃上放心
On July 22, 2015, the State Food and Drug Administration released the “Notice on Carrying Out Self-examination and Verification of Drug Clinical Trial Data” and started the self-examination and verification of clinical trial data of drugs in an all-round way, reforming the examination and approval system for medical and pharmaceutical devices Kicked off. July 21 this year, the State Food and Drug Administration Inspection Center released the “clinical trial data verification phase report” (July 2015 ~ June 2017) demonstrated the preliminary achievements of the reform. The road to reform is not smooth. In the past two years, in the face of the clashes between the old and new ideas, the friction between different interests and the competition for various demands, the food and drug regulatory authorities, in order to let the people eat at ease