Speech by Bi Jingquan at the teleconference of deepening the reform of the national review and approval system and encouraging the innovation of pharmaceutical and medical devices

Source: CFDA on October 1, 2017, the general office of the CPC Central Committee and the general office of the State Council issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices (Ting Zi [2017] No 42), which was published in full on October 8 On October 9, the General Administration held a press conference and Comrade Wu Zhen interpreted it to the media Today, the teleconference is mainly to make arrangements for the implementation of the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices Next, I will make three comments 1、 Fully understand the importance and necessity of deepening reform and encouraging innovation Food and drug safety is related to the health and life safety of more than 1.3 billion people It is a major basic livelihood issue as well as a major strategic issue for economic and social development Since the fourth quarter of 2016, the General Administration of China has organized efforts to study policies to encourage innovation of pharmaceutical and medical devices On May 9 and 10 this year, the General Administration of the people's Republic of China solicited public opinions; on May 10, the office of the leading group of the Central Committee for comprehensively deepening reform listened to the report; on May 12, the working committee of the law of the National People's Congress listened to the report; on May 19, Vice Premier Wang Yang held a special meeting to listen to the report and coordinate relevant policies; at the end of May, the General Administration of the people's Republic of China will encourage the reform of the drug and medical devices on deepening the review and approval system Opinions on Innovation (draft on behalf of others) shall be submitted to the State Council for approval On July 19, the 37th meeting of the leading group of the CPC Central Committee for comprehensively deepening reform deliberated and adopted the opinions (Draft for review), which was clearly printed and issued by the State Office of the CPC Central Committee In the process of drafting, discussion and signing, the document was strongly supported by the Central Compilation office, the national development and Reform Commission, the Ministry of science and technology, the Ministry of finance, the Ministry of human resources and social security, the national health and Family Planning Commission, the State Intellectual Property Office, the Legal Affairs Office of the State Council and other relevant departments All of these show the people-centered development idea of the Party Central Committee and the State Council, and reflect the high attention to the food and drug supervision We need to fully understand the significance of deepening reform and encouraging innovation, further enhance the sense of responsibility, urgency, mission, in-depth learning, understanding and implementation First, deepening reform and encouraging innovation is an urgent need to implement general secretary Xi Jinping's strategic thinking on food and drug supervision and ensure the quality and safety of medicines General secretary Xi Jinping has made important instructions on strengthening food and drug supervision In May 2015, general secretary Xi Jinping stressed the need to speed up the establishment of a scientific and perfect food and drug safety management system and strictly defend every line of defense from farmland to dining table, from laboratory to hospital in the twenty-third collective learning of the Central Political Bureau In July 2017, the 37th meeting of the leading group for comprehensively deepening the reform of the Central Committee emphasized: "we should reform and improve the review and approval system, stimulate the innovation and development vitality of the pharmaceutical industry, reform the clinical trial management, accelerate the review and approval of the listing, promote the consistency evaluation of the quality and efficacy of generic drugs, improve the food and drug regulatory system, promote enterprises to improve their innovation and research and development capabilities, and speed up the delivery of new drugs and good drugs City, to meet the urgent need of clinical medication " Premier Li Keqiang has repeatedly stressed that it is necessary to promote the research and development of drugs, especially major new drugs, promote the upgrading and development of medical device industry, and change the long-term dependence on imports of innovative drugs and high-end medical devices in China as soon as possible In August 2015, the State Council issued the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44) In February 2016, the general office of the State Council issued the opinions of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs (GBF [2016] No 8) In February 2017, the State Council issued the 13th five year national drug safety plan (GF [2017] No 12) The opinions on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices issued by the State Office of the CPC Central Committee is a comprehensive summary and deepening of the experience of the reform of the review and approval system in the past two years, and a concentrated reflection of the strategic decision-making and deployment of the food and drug supervision of the CPC Central Committee and the State Council Second, deepening reform and encouraging innovation is an urgent need to meet the public's need for new and good drugs To meet the urgent need of clinical medication, innovation should be relied on in the final analysis Our country's modern pharmaceutical industry started late and has a poor foundation In the past decade, the state has made great efforts to improve the implementation of production and operation standards, but the low-level repetition of the pharmaceutical industry is still prominent, and there is still a large gap with the international advanced level First, domestic innovation is weak Most of the new chemicals or biological products developed by domestic enterprises are imitated and modified on the basis of the original drugs already on the market abroad In the true sense, only a few varieties of antimalarial drugs, such as artemisinin, are innovated In 2016, the R & D investment of domestic pharmaceutical industry totaled 42 billion yuan, while the R & D investment of some large multinational companies in the world amounted to billions of dollars Second, there are few imported new drugs In 2001-2016, 433 new drugs were approved to be listed in the United States, and only 133 new drugs were listed in China, accounting for 30.7% In the past 10 years, 29 typical new drugs have been listed in China, which are 5-7 years later than those in Europe and America Third, there are many overseas doctors and drugs There are more and more people who go abroad to see doctors through intermediary agencies and buy or invite people to bring in drugs through the Internet Fourth, there is a gap in the efficacy of generic drugs The drugs for the treatment of some major diseases are basically imported drugs, and the domestic imitated drugs cannot form a clinical substitute for the original drugs Fifth, the efficacy of some domestic drugs is not clear Some basic researches on the safety and effectiveness of drugs approved for marketing in the early stage are weak Some production enterprises cut down on production materials and change production process without authorization, which seriously affects the safety and effectiveness of drugs The emergence of these problems is not only related to the legal system of drug marketing license holders is not established, the main responsibility of full life cycle management is not clear, but also related to the policy environment such as insufficient protection of intellectual property rights, lack of clinical trial resources, inadaptability of drug review and approval system and ability, and non matching of innovative drug use policies To promote the reform, we must firmly grasp the fundamental goal of meeting the public's drug demand, the key of drug safety, effectiveness and quality controllability, create a policy environment conducive to encouraging innovation, so that the public can use and afford new drugs in a timely manner, and let doctors have more choices in the process of treating patients Third, deepening the reform and encouraging innovation is the need to promote the supply side structural reform of the pharmaceutical industry and realize the national strategy of innovation driven development "Innovation" is at the top of the five development concepts Since the 18th National Congress of the Communist Party of China, great changes have taken place in the policy and institutional environment of drug innovation There are many favorable conditions for deepening the reform of review and approval system and encouraging drug innovation First, domestic drug innovation is surging In recent years, more and more medical researchers with overseas working experience have returned to China for research and entrepreneurship, and the number of new drug applications and approvals of domestic pharmaceutical enterprises has increased year by year Second, the reform of the review and approval system was carried out in an all-round way The reform of drug and medical device review and approval system started in 2015 has improved the quality standard of review, rectified the bad atmosphere of drug clinical trial data falsification, enhanced the transparency of review and approval, a batch of innovative drugs and medical devices have been approved for listing first, and the review system of drug and medical devices in line with international standards has been gradually established The backlog of drug registration applications has been basically solved Drug evaluation center and medical device technology evaluation center have been included in the government purchase service pilot The staff of drug evaluation center has increased from more than 100 to more than 600 five years ago, and the staff of medical device technology evaluation center has increased from less than 100 to more than 200 Third, the consistency evaluation of quality and efficacy of generic drugs started smoothly In February 2016, the general office of the State Council issued opinions to clarify the relevant policies of consistency evaluation, and some local governments also issued relevant support policies Enterprises are highly motivated to participate in the evaluation of consistency Fourth, the pilot program of listing permit holder system is progressing smoothly In November 2015, the National People's Congress authorized the pilot implementation of the listing permit holder system in ten provinces and cities, which stimulated the enthusiasm of scientific researchers for innovation, and many provinces required it to be generally implemented in the country In a word, it is necessary and possible to deepen reform and encourage innovation The opinions issued by the State Office of the CPC Central Committee is a programmatic document guiding the reform of China's drug and medical device review and approval system The implementation of the opinions will certainly create a good external environment for the innovation and development of the pharmaceutical and medical device industry, stimulate the innovation and development vitality of the pharmaceutical and medical device industry, promote the supply side structural reform of the pharmaceutical and medical device industry, improve the development quality of the pharmaceutical and medical device industry and enhance the international competitiveness, and improve the competitiveness of the pharmaceutical and medical device industry To meet the needs of the public 2、 To comprehensively grasp the goal of deepening reform and encouraging innovation in view of the prominent contradictions faced by the current pharmaceutical and medical device innovation, the opinions put forward 36 reform measures in six aspects, which are very rich in content, each of which is very important and should be fully implemented I would like to focus on ten tasks, including institutional reconstruction, major policy adjustment and capacity-building （1） Expand clinical trial resources At present, there are 989000 medical institutions at all levels in China, including more than 10000 hospitals above the second level and more than 2000 hospitals at the third level However, only more than 600 clinical trial institutions have been identified, and only more than 100 institutions can carry out phase I clinical trials To encourage innovation, the bottleneck of clinical trials must be solved One is to increase clinical resources In the opinion, it is proposed to cancel the qualification of clinical trial institutions and change it to record management The sponsor of clinical trial shall employ a third party for evaluation and certification, and the test items shall be recorded on the website of drug evaluation center The second is to mobilize the enthusiasm of medical staff to participate in clinical trials Clinical trial researchers are equal to clinicians in terms of salary, post promotion and title promotion Third, improve the efficiency of ethical review On the premise of protecting the safety, health and rights of the subjects, we should improve the mechanism of the ethics committee A regional ethics committee was set up to recognize the ethical review conclusions of the multi center clinical trial leader unit Fourth, to ensure the quality of clinical trials The opinion defines the qualifications of the main researchers, the legal responsibilities of the initiators and researchers, and the responsibilities of supervision and inspection of clinical trials For these regulations, the General Administration will issue specific implementation opinions with the national health and Family Planning Commission, and all localities should work with relevant departments to implement them China has a large population base and a wide range of diseases We are fully qualified to take the lead in marketing innovative drugs in China on the premise of protecting the rights and interests of subjects （2） Accept the clinical trial data obtained by the enterprise abroad This is not only an urgent need to speed up the listing of drugs in China, but also a problem in line with international standards GF [2015] No 44 document explicitly encourages the development of international multi center clinical trials, which means accepting the clinical trial data obtained by enterprises abroad In June this year, the General Administration became a member of the International Conference for the technical coordination of human drug registration (ICH) One of the important goals of ICH is to coordinate the international drug registration standards, and the clinical trial data standard is one of the important contents To solve this problem is conducive to reducing the repetition and waste of clinical trials, accelerating the process of clinical trials, reducing the cost and price of drugs on the market, and benefiting more patients Cultivate a large number of professional talents