Combination of national drug supervision

----Sun Xianze, deputy director of the State Food and drug administration, talked about the reform of drug review and approval system Source: China Association for the promotion of drugs (hereinafter referred to as "China Association for the promotion of drug innovation") held the second session of the 10th general meeting of members in Beijing from September 29, 2015 to September 24, 2015 Sun Xianze, deputy director of the State Food and drug administration, attended the meeting and made a special report on drug safety supervision and reform, and exchanged and discussed with representatives and experts of participating enterprises     Sun Xianze spoke highly of CFDA's strategic transformation from imitation oriented to independent innovation in promoting the pharmaceutical industry Through in-depth study of national innovation policies and industrial development issues, CFDA actively made suggestions and suggestions for relevant national pharmaceutical departments, and built a bridge between the government and enterprises At the same time, it strengthened industry self-discipline, carried out international exchanges, and promoted countries in the pharmaceutical field A lot of work has been done in international technical cooperation Sun Xianze pointed out that the CPC Central Committee and the State Council have always attached great importance to the work of food and drug safety supervision According to the task put forward by the 18th National Congress of the Communist Party of China to integrate the functions of food supervision, establish and improve a unified and authoritative food and drug safety supervision agency, as well as the comprehensive and deepening reform deployment made by the Central Committee at the Third Plenary Session of the 18th CPC Central Committee, the General Administration has completed the institutional reform and functional transformation since its establishment two and a half years ago Transformation and team transfer, and carried out a series of special rectification activities In accordance with the "four most stringent" requirements of general secretary Xi Jinping, in view of the slow examination and approval of drug reviews, the General Administration began planning for drug review and approval system reform in 2014 On August 9, 2015, the State Council issued the opinions on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44), marking the comprehensive start of the reform of the drug review and approval system Sun Xianze pointed out that in order to improve the efficiency and scientificity of drug evaluation, the General Administration will take a series of reform measures to strictly control the increment and the stock, including the adoption of "four lights" The strategy is to divide the drug review into several parts; to implement the sunshine review policy to realize the openness and justice of the whole process of review and approval; to make good use of the ten policies to speed up the backlog of drug registration applications and effectively solve the backlog of drug review The General Administration will vigorously promote the quality consistency evaluation of generic drugs, and will issue a series of guiding principles in the near future to comprehensively regulate the selection of reference reagents, in vitro dissolution test and bioequivalence test In addition, the General Administration will study and formulate a series of incentive measures with relevant ministries and commissions to encourage enterprises to complete the consistency evaluation as soon as possible Sun Xianze finally stressed that the reform of the review and approval system of pharmaceutical medical machinery is a major decision of the CPC Central Committee and the State Council, which is of great significance and far-reaching influence in promoting the structural adjustment of pharmaceutical industry, enhancing the international competitiveness of Chinese manufactured drugs and safeguarding the health of the people At present, the momentum of new drug research and development in China is unprecedented It is very favorable for the country to implement the innovation driven development strategy and improve the manufacturing quality in China We should seize this historical opportunity to promote the structural adjustment and industrial upgrading of the pharmaceutical industry with institutional innovation, so as to put Chinese manufacturing on the road of medium and high-end development