Wu Zhen, State Food and Drug Administration: pushing forward the reform of drug examination

Source: on the afternoon of March 7, 2017, the medical and health sectors of the CPPCC National Committee held a joint group meeting Some CPPCC members discussed such topics as the reform of the examination and approval system for medical devices, drug innovation, the promotion of the development of traditional Chinese medicine, and the reform of the medical and health system Wu Zhen, deputy director of the State Food and drug administration, attended the meeting as a nonvoting delegate and exchanged views with members present on the reform of drug review and approval system Wu Zhen introduced that since August 2015, the General Administration of China started the reform of drug review and approval system, through a series of measures, the backlog of drug registration applications has been effectively alleviated, and the number of drug registration applications has been reduced from the peak of 22000 to nearly 8000 By the end of 2017, the annual import and export balance of drug registration applications will be achieved, and the review will be completed according to the time limit by the end of 2018 In the process of reform, the General Administration of China has continuously optimized the drug review and approval process, improved the review efficiency, and built a drug review and approval system with review as the center and clinical orientation; increased the review force, and now the drug review center of the General Administration of China has increased from 150 to 600; with the goal of improving the quality of drugs and encouraging innovation, the innovative drugs and clinically urgently needed drugs have been optimized The quality and efficacy of generic drugs should be consistent with the original drugs to achieve clinical substitutability, so as to improve the quality of generic drugs and reduce medical costs Wu Zhen said that although the reform of drug review and approval system has achieved some results, it still lags behind the expectations of the public and needs to be further deepened Next, the General Administration will explore the change of drug clinical trial organization certification from licensing system to filing system; encourage enterprises to carry out international multi center clinical trials, and welcome multinational enterprises to apply for drug registration in China as soon as possible; research patent protection, data protection and other policies to create a good policy environment for drug research and development innovation Wu Zhen said that the reform of the drug review and approval system has started, and the General Administration will continue to work hard to make the pace of reform more solid and ensure the safety of drug use for the people He also hoped that members of the CPPCC National Committee would give more valuable opinions and suggestions for the reform Original title: Wu Zhen said at the joint group meeting of the CPPCC medical and health sectors: let the pace of drug examination reform be more solid