Most of the reform documents were issued! This is what the representatives of the two sessions of the pharmaceutical industry said

Source: Churchill, e-medicine manager, said on March 5, 2018 that our country is as brave as a lion I'm just lucky to roar for it For the Chinese pharmaceutical industry, a new era has come On the morning of March 4, a symposium of CPPCC members, the representatives of the 10th "voice responsibility" pharmaceutical industry people's Congress, jointly built by 25 associations (schools) in China's pharmaceutical industry, including China Pharmaceutical Enterprise Management Association and China Chemical Pharmaceutical Industry Association, was held in Beijing More than 40 CPPCC members from the NPC and CPPCC of the NPC and CPPCC attended the meeting to make suggestions and suggestions for the development of the pharmaceutical industry in 2018 At the same time, the heads of CFDA pharmaceutical registration department, pharmaceutical supervision department, medical reform office of the State Council, medical insurance Department of the Ministry of human resources and social security and other ministries and departments participated in the symposium This year, the Symposium of CPPCC members, representatives of the people's Congress of the voice and responsibility medicine industry, is the 10th According to preliminary statistics, 330 deputies to the National People's Congress and members of the Chinese people's Political Consultative Conference have attended the previous nine symposiums Collected 673 opinions and Suggestions Submitted by the majority of grass-roots pharmaceutical enterprises and institutions, and sorted out and extracted 16 materials as proposals and suggestions, most of which were signed and reported as opinions and proposals, and received serious discussion, feedback and reply from relevant government departments, and served as an important reference for the reform and improvement of administration of government departments At the same time, Xinhua news agency was authorized to issue the decision of the CPC Central Committee on deepening the reform of the party and state institutions The release of this document also confirmed the main direction of the discussion on the reform of the major system on the eve of the two sessions   Since the CPC Central Committee and the State Council vigorously promoted the drug regulatory reform in 2015, the State Food and drug administration has implemented the four most stringent requirements, strengthened the supervision of the whole process of drugs, promoted the reform and innovation of drug review and approval system, launched a series of policies and measures, carried out a good top-level design, involving all aspects of drugs from research and development to marketing And achieved remarkable results Churchill once said, "our country is as brave as a lion I'm just lucky to roar for it." For the Chinese pharmaceutical industry, a new era has come On the eve of this year's NPC and CPPCC, the topic of major system reform has attracted the attention of the outside world again, and where the food and drug regulatory system will go in the future has become the focus of the industry At present, in the face of the new requirements of the new era and new tasks, the setup and function allocation of the party and state institutions are not fully adapted to the requirements of promoting the "five in one" overall layout and the "four comprehensive" strategic layout in a coordinated manner, and to the requirements of realizing the modernization of the national governance system and governance capacity Among them, the establishment and division of responsibilities of some government agencies are not scientific enough, the lack of responsibilities and low efficiency are prominent, and the transformation of government functions is not in place, which is considered as one of the main manifestations of incomplete adaptation In terms of changing the functions of the government, it was decided to improve the public service management system We will strengthen and optimize the functions of the government in social security, education and culture, legal services, health care and medical security, so as to better protect and improve people's livelihood We will promote the diversification of public service providers, such as education, culture, law, health, sports, health and pension, and the diversification of their modes of delivery We will promote market-oriented reform of non basic public services, introduce competition mechanisms, and expand the purchase of services We will strengthen, optimize and coordinate national emergency response capacity-building, build a unified leadership, authority and responsibility consistent, authoritative and efficient national emergency response capacity system, improve our ability to ensure production safety, public security, disaster prevention, mitigation and relief, and ensure the safety of people's lives and property and social stability Previously, it was widely speculated that the State Council would integrate the functions of industry and commerce, quality supervision and food and drug departments, and set up an institution similar to the General Administration of market supervision In the food and drug system, the drugs and medical devices will be under the management of the national health and Family Planning Commission, and the food will be under the supervision of the large market, and thus a unified, authoritative and professional supervision system will be established Sun piaoyang, deputy to the National People's Congress and chairman of Hengrui pharmaceutical, believes that there are three new characteristics of the drug regulatory system in the new era: new direction, new standards and new achievements We will implement the national strategy for innovation and development and the strategy for a healthy China We will focus on the people, and encourage innovation and improve quality According to international standards, the consistency evaluation of generic drugs will be carried out, and the accession to ich will further help the reform of drug regulatory system and promote the development of the industry Through the reform, the problem of drug registration backlog has been effectively solved, the consistency evaluation of generic drugs has achieved initial results, and the speed of new drug review and approval has been greatly accelerated Hu Jiqiang, deputy to the National People's Congress and chairman of Kangenbei, said that the majority system reform must be based on how to improve the national governance system, accelerate the construction of the national governance system, and modernize the governance capacity At the same time, he also said that he hoped to build an integrated system around the health of the people This integrated system can even put the three doctors together, which will help coordinate the whole health policy and industrial policy, and promote industrial progress Zhao Chao, deputy to the National People's Congress and President of step pharmaceutical, believes that no matter how the department changes, the first goal should be clear All reforms should be conducive to the development of this society, the development of society should be conducive to the development of the whole industry, the development of enterprises and the development of industry The goal should be gradual Second, the formulation of policies should be scientific and sustainable There should not be an idea of leading a department No enterprise can face such policies According to Ding liming, deputy to the National People's Congress and chairman and CEO of Beida pharmaceutical, the development of the pharmaceutical industry lacks a leading department and needs to integrate its functions If we can integrate the functions together, we can move even if we don't connect, which is the direction of reform He said frankly that it would be an ideal state to have an authoritative department to coordinate the management of approval, bidding, reimbursement and other links, and hoped that such a state would come a day earlier Geng Funeng, deputy to the National People's Congress and chairman of gooddoctor Pharmaceutical Group Co., Ltd., also has a similar view He said that the organizational structure and organizational system must adapt to the changes and development of the times, or there will be contradictions if they do not adapt In his opinion, the phenomenon of water control in Kowloon in the past will be improved through the reform of most systems 2 In the new stage of drug review reform, since the beginning of drug review reform in 2015, the industry has praised a series of drastic reform measures to solve the drug backlog, speed up the review and approval of new drugs, encourage innovative drugs, and join the international standards of ICH docking It is the general trend of the pharmaceutical industry to open the way and bridge the gap between water and mountains and carry out the reform to the end What kind of optimization is needed next? Sun said that in the new era, we should first continue to encourage the development of new drug clinical trials, implement the ind 60 day licensing system, implement the technical guidelines for the application of new drug phase I clinical trials and other reform provisions, and implement the recognition of overseas data Secondly, we should continue to optimize the process of new drug market review and approval, gradually change the current trend of "every review must be checked", realize the synchronous production site inspection and clinical experiment site inspection, and introduce specific processes and requirements for rolling data submission Third, establish data protection suitable for national conditions, and actively improve the initiative of innovation Fourth, strengthen the publicity, implementation and guidance of drug regulatory reform policies, and establish the necessary transition period Ding Liming also put forward his own suggestions for drug review and approval He believes that in order to further optimize the approval process of clinical information resources, the approval process can be completely optimized, or even changed to a filing system Secondly, it is worth discussing how to effectively connect human resource examination and approval with leading hospital in the pre examination and approval process of clinical research Finally, the overseas projects need to be further optimized in clinical process Yue bingfei, member of the CPPCC National Committee and researcher of CFDA, said that in the past two years, the reform of drug review and approval in China has been obvious to all, with great changes In this new era, with the new reform requirements and the new institutional adjustment, pharmaceutical enterprises need to strengthen their sense of responsibility, because now many requirements are to take enterprises as the first responsible person, so that enterprises can better develop and adapt to the market demand As one of the important contents of drug trial reform, consistency evaluation will meet the final limit this year Up to now, CDE has published two batches of drugs that have passed the consistency evaluation Although the industry has different opinions on whether to complete on time, at present, the consistency evaluation has achieved preliminary results Liu Xiaoying, member of the CPPCC Chongqing Committee and general manager of Chongqing Huasen Pharmaceutical Co., Ltd., believes that at present, CFDA has made positive progress in organizing and implementing conformity assessment, and has also completed relevant top-level design and process design, including relevant laws and regulations as well as specific implementation methods However, domestic enterprises have encountered the problem of how to promote the original research enterprises to actively declare the reference preparation materials in the consistency evaluation, so as to facilitate the imitation enterprises to carry out the consistency evaluation She suggested that on this issue, the original research enterprise should take the measures of time limited declaration of reference preparations Liu HD, member of CPPCC Chongqing Committee and chairman of Chongqing pharmaceutical exchange