Press conference of the Standing Committee of the people's Congress

Reporter of Legal Daily: the first comprehensive revision of the drug administration law was carried out every 18 years Please introduce the new system and highlights of the revision Yuan Jie, director of the policy and regulation department of the State Drug Administration: the drug administration law is a comprehensive overhaul 18 years later The drug administration law was formulated in 1984 and revised in February 2001 Except for the individual clauses that were revised in December 2013 and April 2015 due to the reform of "release of management service", there was no major revision This comprehensive revision of the drug administration law reflects the "four latest" The first is to combine drug management and people's health closely In the purpose of legislation, it is clearly stipulated to protect and promote public health As for the relationship between medicine and health, from the perspective of the concept of drug development around the world, it is constantly improving At first, our draft did not promote, only to protect public health With the deepening of the concept, medicine Quality management should not only protect but also promote public health The combination of drug administration and people's health is also reflected in Article 3, which clearly puts forward that people's health should be the center of drug administration In the whole process of drug management system design, we adhere to reflect this concept The second is to adhere to risk management, which runs through the concept of risk management in drug development, production, operation, use, post marketing management and other aspects, and adhere to social co governance The third is new We should adhere to the problem orientation in the new development period, problems in the development process of drug management, adhere to the problem orientation, respond to social concerns, and resolutely implement the principle of "four strictest" The fourth new is to give full play to the supreme authority of the law and make regulations on drug management around the improvement of drug quality system As you know, this draft was revised for the first time According to the opinions of all parties and the practical needs of the development of China's pharmaceutical industry, it was changed from the second trial to the revised draft, which comprehensively and systematically stipulated the pharmaceutical management system People's Daily: May I ask the drug regulatory bureau, in order to enable the public to use and afford good drugs faster, the State Council requires to speed up the examination and approval of new drugs already on the market overseas, and strengthen the supply guarantee of drugs in short supply What are the measures taken by the newly revised Drug Administration Law to encourage R & D innovation and ensure the accessibility of drugs? Ms Liu Pei, director of the Department of policies and regulations of the State Drug Administration: the CPC Central Committee and the State Council attach great importance to drug innovation to meet the needs of the people's drug use In 2015, they issued the opinions on reforming the review and approval system of pharmaceutical medical machinery, and in 2017, they issued the opinions on deepening the reform of the review and approval system to encourage the innovation of pharmaceutical medical devices The State Council has also held many meetings, which put forward requirements for promoting the innovation and upgrading of the pharmaceutical industry and accelerating the review and approval of new drugs and anticancer drugs abroad The State Food and drug administration has conscientiously implemented the deployment of the CPC Central Committee and the State Council, issued a series of measures to encourage innovation and accelerate the review and approval, greatly mobilizing the enthusiasm of drug enterprises in research and development In terms of applications for innovative drugs, there was a 75% increase in 2018 over 2016 In 2018, we approved 48 new drugs, 18 of which are anti-cancer drugs, an increase of 157% over 2017 In the process of revising the drug administration law, the National People's Congress summed up the reform experience, drew lessons from the international experience, and listened to the opinions extensively In the general provisions of the drug administration law, it clearly stipulated that the State encourages the research and development of new drugs, and at the same time, it has increased and perfected more than ten articles, and increased a number of system measures In order to encourage innovation, speed up the listing of new drugs, and meet the public's better use of good drugs and availability Good medicine has released a series of institutional dividends The specific systems of drug administration law are as follows: first, it defines the direction of encouragement, focuses on supporting drug innovation oriented by clinical value and has definite curative effect on human diseases We will encourage the development of new therapeutic mechanisms for serious life-threatening diseases, rare diseases and medicines for children The second is to innovate the evaluation mechanism, strengthen the capacity-building of evaluation institutions, improve the communication and exchange mechanism with registered applicants, establish an expert consultation system, optimize the evaluation process, improve the evaluation efficiency, and provide organizational guarantee for drug innovation The third is to optimize the management of clinical trials In the past, the approval system of clinical trials was changed to implied permission system, and the certification management of clinical trial institutions was adjusted to record management, which improved the approval efficiency of clinical trials Fourth, establish related review and approval During the review and approval of drugs, adjust the chemical raw materials, related auxiliary materials and packaging materials and containers in direct contact with drugs to be reviewed and approved together with preparations, and simultaneously approve the quality standards, production processes, labels and instructions of drugs Fifthly, priority has been given to review and approval, and green channels have been set up for new drugs and children's drugs that are urgently needed in clinic, for the prevention and treatment of major infectious diseases and rare diseases Sixth, the system of conditional examination and approval has been established It means that for the treatment of diseases that are seriously life-threatening and have no effective treatment means, as well as the drugs urgently needed in public health, the clinical trials have data showing the efficacy, and can predict the clinical value of conditional approval, so as to improve the accessibility of the drugs urgently needed in clinical trials This system shortens the development time of clinical trials, so that those patients who urgently need treatment can be the first time Use new drugs in between Of course, we also have stricter requirements for conditional approval For example, relevant matters should be stated in the drug registration certificate After the drug is listed, the holder of the drug listing license should take more strict risk control measures to complete the relevant research within the prescribed time limit If the relevant research is not completed, or it can not be proved that the benefits are greater than the risks, the SFDA can also Handle according to law, or even directly cancel the drug registration certificate Such regulations not only meet the clinical needs, but also ensure the safety of drugs on the market Of course, for the shortage of commonly used drugs and emergency drugs, which are highly concerned by all sectors of the society, the newly revised Drug Management Law also stipulates the drug reserve and supply, and puts forward the requirements of "treating both symptoms and symptoms, and coordinating multiple departments" In addition to giving priority to the review and approval of drugs urgently needed in clinical practice, the drug reserve system has been stipulated, the monitoring system of drug supply and demand has been established, the management of drugs in short supply has been improved, the main responsibility of drug production and supply guarantee has been clarified, and the drug guarantee has been strengthened In the next step, SFDA will implement the important decisions and arrangements of the CPC Central Committee and the State Council, fully implement the requirements of the drug management law, improve the specific measures to encourage innovation, continue to actively cooperate with relevant departments to accelerate the work of ensuring the supply of drugs in short supply, and effectively guarantee the availability of drugs for the people Chengdu Business Daily: with regard to the drug administration law, the newly revised Drug Administration Law fully implements the drug listing license holder system What is the significance of the full implementation of this system for strengthening drug safety supervision and implementing the main responsibility of enterprises? Liu Pei: just now, the reporter's question about the holders of marketing license has caught the focus of the new revision of the drug administration law Because the newly revised Drug Administration Law has established the system of marketing license holders The first is to implement the main responsibility of the whole life cycle of drugs Second, it can stimulate market vitality, encourage innovation and optimize resource allocation What is a listing permit holder? The system of marketing license holder is a system in which drug R & D institutions and manufacturing enterprises with drug technology obtain drug registration certificate by applying for drug marketing license, put products into the market in their own name, and take responsibility for the whole life cycle of drugs Some people say that the holder of the listing license is also the producer, or the Licensee In November 2015, the National People's Congress, drawing on international experience, authorized the State Council to carry out pilot drug listing license holder system in ten provinces and cities, including Beijing, at the 17th meeting of the Standing Committee of the 11th National People's Congress In the past four years, positive results have been achieved, which has played a positive role in strengthening the management of drug life cycle, encouraging innovation, reducing low-level duplication and optimizing resource allocation 。 In the process of the new revision of the drug administration law, the National People's Congress summed up the experience of the pilot project, took people's health as the center, improved the system of scientific supervision, set up special chapters, and clarified the main responsibility of the listing license holders for drug quality and safety in relevant chapters, strengthened the supervision of the whole process, and provided legal guarantee for the implementation of the main responsibility of enterprises In the general principles, the drug administration law makes clear that the State implements the system of listing license holder for drugs, and the listing license holder is responsible for the safety, effectiveness and quality controllability of drugs in the whole process of drug development, production, operation and use according to law At the same time, it is stipulated that the holders of marketing license should establish a quality assurance system, and be responsible for the whole process and all links of non clinical research, clinical trial, production and operation, post marketing research, adverse reaction monitoring, report and treatment of drugs Besides the ability of quality management and risk prevention and control, the holder of listing license should also have the ability of compensation For the holders of overseas listing licenses, the enterprise legal person in China shall be clearly designated to perform the obligations of the holders and bear joint and several liabilities In the development process, it is required that the holder must abide by the quality management standards for non clinical research and drug clinical trials to ensure the continuous compliance of the whole process of development In the production process, it is required to establish a quality management system to ensure the continuous legal compliance of the whole production process In the case of commissioned production, a qualified pharmaceutical manufacturer shall be entrusted to sign relevant agreements to examine and verify the ex factory release of the pharmaceutical manufacturer In the circulation link, it is stipulated that the holder shall establish a traceability system to ensure the traceability of drugs, and those entrusted for sale shall also entrust qualified drug distributors In case of consigned warehousing and transportation, the ability of the consignor shall be evaluated, the drug quality responsibility and operation regulations shall be clarified, and the consignor shall be supervised In the aspect of post marketing management, the holders are required to make risk management plans, carry out post marketing research, and strengthen the continuous management of listed drugs, including post marketing evaluation At the same time, it is required to establish adverse reaction report and recall system In addition, the holder should establish an annual report system, and submit the information of drug production and sales, post marketing research, risk management, etc to the drug regulatory authorities every year At the same time, the legal representative of the drug listing license holder is fully responsible for the drug quality While clarifying the responsibilities of the holders, the drug management law also makes a series of provisions for the research and development units, production enterprises, trading enterprises and users of drugs, requiring them to comply with the requirements of laws, regulations, standards and specifications, strictly follow the laws and regulations in the process of production, operation and use, and ensure the authenticity, accuracy, integrity and traceability of the information in the whole process The newly revised Drug Administration Law also stipulates the contents of drug vigilance, supervision and inspection, credit supervision, information disclosure, emergency disposal, etc., implements the concept of full life cycle management, refines and improves a series of regulatory measures such as warning, interview, rectification within a time limit, suspension of production and sales, use and import, and urges the holders to fulfill their main responsibilities Yuan Jie: let me add One of the major advantages of the newly introduced system is to encourage innovation in system design In addition to production enterprises