Bi Jingquan had a discussion with the heads of more than ten pharmaceutical enterprises: what was discussed in deepening the reform of drug review and approval system?

Source: on October 31, 2016, in order to thoroughly implement the spirit of the Sixth Plenary Session of the 18th CPC Central Committee and the decision-making and deployment of the CPC Central Committee and the State Council on food and drug safety supervision, accelerate the improvement of drug quality and safety level, and promote the innovation driven development of the pharmaceutical industry, medical economic news, October 30, 2016 Bi Jingquan, director of the food and drug administration, presided over a symposium to listen to the opinions and suggestions of drug R & D and production enterprises on the reform of drug review and approval system More than 10 heads of pharmaceutical companies from China attended the forum It is agreed that the determination of the state to reform the drug review and approval system is a great good thing for the benefit of the country and the people It is of great practical significance and far-reaching influence for building a modern drug regulatory system, improving the quality and competitiveness of Chinese manufactured drugs, and better meeting the public's drug safety and effectiveness The dividend of reform is gradually released, the review and approval of innovative drugs are accelerated, the effect of survival of the fittest is emerging, and the innovation ecosystem of the pharmaceutical industry is significantly improved It is suggested that we should continue to carry out the reform to the end, further improve the evaluation standards and technical guidelines, strengthen the construction of evaluation experts and technical teams, provide more powerful guidance for the R & D and production of enterprises, and create a policy environment of "three medical linkage" that encourages innovation Bi Jing pointed out that the Party Central Committee with Comrade Xi Jinping attached great importance to the work of food and drug safety In the sixth Plenary Session of the 18th CPC Central Committee, the party made further adjustments to the construction of food and drug safety management system, the reform of the examination and approval system for drugs and medical devices, and the reform of the drug circulation system Since the reform and opening up, the accessibility of drugs in China has been preliminarily solved, and the quality and supervision level of drugs have been gradually improved, but there is still a gap with the expectations of the people At present, the problems existing in the research and development, production, circulation and use of drugs are essentially supply side problems, and the supply quality does not meet the growing demand of the people The regulatory authorities should firmly establish the people-centered concept to ensure the quality and efficacy of the drugs on the market Bijingquan stressed that efforts should be made to establish a drug review and approval system that encourages innovation, improve laws and regulations, policies and measures, and technical guidelines, reconstruct drug review process with clinical orientation, integrate regulatory resources with review as the center, improve review ability and regulatory efficiency, and study policies closely related to innovation, such as clinical trial management, data protection, patent link, etc., with regulatory system To promote the transformation and upgrading of pharmaceutical industry and supply side structural reform We should change the concept of supervision, integrate supervision into service, strengthen communication with the industry, guide enterprises to implement quality and safety management standards, and improve product quality and international competitiveness It is necessary to promote the evaluation of quality and efficacy consistency of generic drugs to realize the clinical substitution of generic drugs and original drugs We will do a good job in the pilot of drug listing license holder system and process verification, summarize experience and improve policies Bijingquan highly affirmed the important role of enterprises in the reform of drug review and approval system He pointed out that we should further enhance confidence in developing innovative industries To make pharmaceutical enterprises bigger and stronger is conducive to promoting the transformation of pharmaceutical industry from relying on quantity expansion to focusing on quality and efficiency, and to promoting the well-being of the masses Enterprises are the main body to ensure the quality and safety of drugs, the main force of technological innovation, and the important force to promote the reform and innovation of regulatory system It is hoped that pharmaceutical enterprises will actively participate in the reform of the review and approval system, give full play to their own advantages, actively make suggestions and suggestions, and work together with regulatory authorities to improve relevant system specifications We should strictly follow the laws and regulations of drug production and operation, improve the ability of quality and safety assurance, and ensure the safety and effectiveness of drugs on the market The leaders of cornerstone biopharmaceutical, Qilu pharmaceutical, Tianshili pharmaceutical, Boskin biopharmaceutical, treasure island pharmaceutical, kangzhe pharmaceutical, Corning Jerry biopharmaceutical, Beijing Kaine biopharmaceutical, Xiansheng pharmaceutical, Rongchang pharmaceutical, Shenwei pharmaceutical, Shenghe pharmaceutical and experts from Shenyang Pharmaceutical University attended the symposium Wu Zhen, deputy director of the General Administration, sun Xianze, as well as the leading comrades of the relevant departments and directly subordinate units attended the symposium.