Speech by Mr. Bi Jingquan at the founding meeting of the 11th Pharmacopoeia Committee (August 29, 2017)

Source: the drug review center of the State Food and Drug Administration 2017-09-03 today, we are here to hold the inaugural meeting and the first plenary meeting of the 11th Pharmacopoeia Committee On behalf of the food and drug administration, I would like to extend my warm congratulations on the opening of the conference! Express sincere greetings to all members, especially the newly elected members! The main tasks of this meeting are: to deploy the preparation of Chinese Pharmacopoeia 2020, to promote the reform of drug standards, to strengthen the whole process management of drug standards, and to further improve the level of drug quality Next, I would like to make a few comments 1、 Fully understanding the extremely important Pharmacopoeia of drug standards is the crystallization of the achievements in the development of drug science and technology, the symbol of the development level of a country's drug industry, the basic compliance of drug manufacturers and operators, and the criterion of drug supervision Since the eighteen Party Congress, general secretary Xi Jinping has repeatedly stressed the need to implement the "most rigorous standards, the most stringent supervision, the most severe punishment and the most serious accountability" to ensure the safety of people's diet and medication General secretary Xi Jinping put the most stringent standards in the first place, highlighting the extreme importance of standards for drug supervision General secretary Xi Jinping also stressed that "Whoever sets standards will have the right to speak Whoever masters the standards will occupy the commanding heights", and profoundly expounds the decisive role of standards in product quality Premier Li Keqiang has repeatedly stressed the need to make up his mind to improve the quality of drugs and strictly abide by every line of defense from the laboratory to the hospital The CPC Central Committee and the State Council attach great importance to the work of drug standards In 1949, when new China was just founded, experts were organized to study and compile the new Chinese Pharmacopoeia, and the construction of drug standardization was taken as a strategic measure to change the weak foundation of China's pharmaceutical industry and the backwardness of the people's lack of medicine In 1950, the Pharmacopoeia Committee of the people's Republic of China was established, which is the earliest standardization organization in New China In 1953, the state promulgated the first edition of Chinese Pharmacopoeia After the reform and opening up, the drug administration law has made clear the legal status of drug standards and the legal responsibilities of the Pharmacopoeia Committee It compiles a version of Pharmacopoeia every five years, and the work of drug standards and the preparation and revision of China Pharmacopoeia has stepped into the track of legalization Up to now, China has promulgated and implemented ten editions of Pharmacopoeia, which plays an important role in improving the quality of drugs and promoting the transformation and upgrading of the pharmaceutical industry All previous Pharmacopoeia committees have made great contributions We have made great efforts to improve drug safety standards and strengthen drug safety supervision In recent years, there have been no major adverse drug events These should be fully affirmed However, we also need to see that due to historical conditions, the industrial development started late, the government's regulatory capacity is weak, the drug standards can not meet the needs of regulatory, and there is still a gap with the expectations of the people There is a gap between the quality and efficacy of drugs and the United States, Europe and Japan To a large extent, the standards for drug listing are not high, and the original research products are not available as reference controls in the market There are also some problems, such as lack of standards, backward standards, ineffective standards and inadequate implementation of standards We should conscientiously implement the important instructions of general secretary Xi Jinping on drug supervision, speed up the revision of standards, set up a scientific, comprehensive, verifiable and execable standard system, improve the efficacy of drugs with the "most stringent standards", prevent drug safety risks, and lay a solid foundation for drug supervision 2、 I would like to invite all members of the Pharmacopoeia Committee to study several issues when the new pharmacopoeia committee is established and the preparation of Pharmacopoeia 2020 is fully launched These issues are of great significance to the formulation of standards, the revision of laws, the promotion of reform and the strengthening of supervision （1） Study the orientation of Pharmacopoeia work The compilation of Pharmacopoeia should carry out the people-centered development idea, serve the drug supervision, reform and innovation, and serve the development of pharmaceutical industry The purpose of compiling pharmacopoeia is to encourage the good medicine, eliminate the bad medicine and identify the fake medicine （2） To study the essential characteristics of modern medicine and traditional medicine, as well as the differences between modern medicine and traditional medicine The constitution of the people's Republic of China and the drug administration law both put forward the requirements for the development of modern medicine and traditional medicine It is necessary to study the basic concepts of modern medicine and traditional medicine, and clearly define their connotation and extension The concept of medicine has existed since ancient times Each nation has its own traditional medicine in history Chinese medicine culture in China is more extensive and profound, which plays an important role in the reproduction of the Chinese nation and the fight against diseases We have experienced the era of lack of medicine, mainly referring to the lack of modern medicine Modern medicine was introduced into China along with modern medicine Modern medicine, based on traditional medicine and modern evidence-based medicine, has gradually improved and formed today's basic characteristics: Based on the theories of medicine, chemistry, biology, etc.; generally, it has clear active ingredients, and constantly studies and improves its mechanism of action; through randomized double-blind large sample clinical trials, it has been proved to be effective for certain indications and individual patients through test data The benefits of prevention or treatment of a specific disease in a person or human society outweigh the risks Therefore, the drug evaluation should be clinical oriented, with the reviewer with the background of the clinician as the evaluation leader In addition, there are also production methods and processes approved by regulatory authorities to ensure uniform and stable quality; comprehensive supervision of drugs, full life cycle responsibilities of drug marketing license holders, post marketing research, monitoring of adverse reactions, improving the understanding of drugs, including side effects, taboos, precautions, etc in the drug manual; and listed drugs The standard system of continuous evaluation and withdrawal from the market Under the guidance of traditional medical theory and traditional preparation method, traditional medicine adopts traditional dosage form and use mode, traditional indication expression and traditional evidence-based method, which has been used for many years and recognized by the public The traditional theory of traditional Chinese medicine is the cultural treasure of the Chinese nation We must carry forward and inherit the development The most important difference between modern medicine and traditional medicine is the double-blind randomized large sample clinical trial evidence, the conclusion that the benefit is greater than the risk of indication, the product is uniform and stable quality control If we use modern medicine, modern pharmaceutical theory, modern preparation method and modern evidence-based method to study traditional medicine, the results should be reported, reviewed and supervised according to modern medicine In recent years, we have made important achievements in the research and development of traditional medicines by modern pharmaceutical methods The discovery of artemisinin, berberine and ephedrine, especially artemisinin, is our great contribution to human society The research on the treatment of leukemia with arsenic trioxide is also a remarkable achievement We should carefully sum up the experience and lessons of natural drug development and research in recent years, what are the clinical acceptance and internationally recognized achievements, what are the lessons, and what detours we have taken, which are of great significance for us to inherit and develop traditional drugs （3） To study the relationship between new drug market standard, orange peel book and pharmacopoeia According to the concept and practice of modern drug supervision, the approval of an innovative drug on the market is to approve the standards of a drug, including active ingredients, formula, way of use, dosage form, specification, use method, manufacturing process and process parameters as business secrets of the enterprise These are also the regulatory basis after the product goes on the market The enterprise must produce according to the approved standard The data of the whole production process must be true, complete, recorded in time and traceable Otherwise, it will be punished as adulterated drugs The new drug approved by the regulatory authorities is original and benchmarking, and its patent application is protected by the patent law After the expiration of the patent, enterprises applying for the production and listing of generic drugs can borrow the achievements and data of the original research enterprise to avoid re conducting large sample clinical trials The regulatory department reviews its pharmaceutical equivalence and bioequivalence according to the standards of the original research drug, and the equivalence of the two is regarded as the efficacy equivalence, which can be replaced each other clinically The original research drug approved for marketing as a reference preparation and the generic drug equivalent to the evaluated efficacy are listed in a catalog set and updated in time, which is the international orange peel book system We should also establish the orange book system in China We need to study the standards for approval of new drugs, the relationship between orange peel books and pharmacopoeia, and what roles each plays The compilation and revision of Pharmacopoeia, in a sense, is a re examination and confirmation of the drugs on the market In the process of compiling Pharmacopoeia, the authenticity, reliability and scientificity of the contents collected, updated and revised should be examined, and its safety, effectiveness and quality controllability should be evaluated In case of any doubt in authenticity, reliability and scientificity, safety, effectiveness and quality controllability, the handling opinions and suggestions shall be put forward to the regulatory authorities; in case of any drug that has not been produced for many years, the handling opinions and suggestions shall be put forward; in case of any drug that has not been subject to adverse reaction monitoring for many years after being put on the market, the handling opinions and suggestions shall also be put forward Members of the committee should strictly control the revision of the Pharmacopoeia, which is the responsibility of the public and the expert committee （4） The results of reform should be reflected in the revision of Pharmacopoeia to serve the reform and innovation Since 2015, the General Administration has earnestly implemented the decision-making and deployment of the Party Central Committee and the State Council, and comprehensively promoted the reform of drug review and approval system with relevant departments The reform is not limited to review and approval, but gradually expanded to a comprehensive reform of the drug regulatory system Why reform? First, the accessibility of drugs is basically solved, but there is a gap in quality and efficacy Second, there are ecological problems in drug research and development, production and distribution The data in R & D is untrue and incomplete; the process of production and processing is changed without authorization, adulterated to make fake and Jerry built; the data is incomplete, untrue, unreliable and traceable; the phenomenon of exaggerating propaganda and boasting without scientific basis in the distribution process is not uncommon, which is not uncommon Third, the strength of review and supervision is weak Compared with the rapid development of the pharmaceutical industry, our supervision team is seriously lack of personnel, insufficient capacity, difficult to implement effective supervision, and many loopholes We are aware of the existing problems, but we have many difficulties in solving them, and we are lack of spare efforts Fourth, the application backlog is inefficient This is the inevitable result of the interweaving of the first three problems How to reform? The Party Central Committee and the State Council have made a series of major decisions In August 2015, the State Council issued opinions on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44), in November 2015, the Standing Committee of the National People's Congress approved the pilot implementation of the drug listing license holder system in 10 provinces and cities, and in February 2016, the general office of the State Council issued opinions on the evaluation of the quality and efficacy of generic drugs (GF [2016] No 8) ）In February 2017, the State Council issued the 13th five year plan for national drug safety (GF [2017] No 12) In July 2017, the leading group of the Central Committee for comprehensively deepening the reform reviewed and approved the opinions on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices With the approval of the State Council, we have joined the International Conference for the technical coordination of human drug registration (ICH), and we will strive to join the International Cooperation Organization for Drug Certification (PIC / s) in the next step The general goal of the reform is to be in line with the international standards.