Medical network - on September 4, August 29, 2017, the director of the state administration of food and drug supervision and administration, the eleventh committee, director of the pharmacopoeia committee jingquan comrades on the 11th pharmacopoeia committee meeting delivered an important speech. The full text of the speech:
Today, we are here to hold the inaugural meeting of the 11th pharmacopoeia commission and the first plenary meeting. On behalf of the general administration of food and drug administration, I would like to extend my warm congratulations on the opening of the conference. Sincere greetings to all members, especially the newly elected members!
The main task of this meeting is: the deployment of 2020 "China pharmacopoeia" compilation work, promote the reform of pharmaceutical standards, strengthen the administration of the drug standards fully promote drug quality level to further improve. Let me give you some ideas.
1. To fully understand the extreme importance of drug standards
Pharmacopoeia is the crystallization of the development of pharmaceutical science and technology. It is a symbol of the development level of drug industry in a country. It is the basic compliance of drug production operators and the criterion of drug supervision. Since the eighteenth congress, general secretary of xi jinping stressed several times, to "the most rigorous standards, strict regulation, the most severe punishment, the most serious accountability" into effect, to ensure that the people diet drug safety. Xi jinping put "the most rigorous criteria" first, highlighting the extreme importance of standards for drug regulation. Xi also stressed that "whoever sets the standard has a say. Who grasps the standard, who occupies the commanding point ", elaborates the standard to the product quality decisive effect. Premier li keqiang has repeatedly stressed his determination to improve the quality of medicines and strictly observe every line of defense from the laboratory to the hospital.
The party central committee and the state council attach great importance to drug standards work. In 1949, the new China was founded, organization and experts pharmacopoeia of the People's Republic of China, the standardization of drug construction as changing our country medicine industry foundation is weak, underserved backward situation among the masses and the strategic measures. In 1950, the pharmacopoeia commission of the People's Republic of China was established, which was the earliest standardization organization in new China. In 1953, the state promulgated the first edition of the Chinese pharmacopoeia. Drugadministration law, after the reform and open policy has been clear about the pharmaceutical standards of the pharmacopoeia committee of legal status and legal responsibility, every five years to compile a version pharmacopoeia, drug standard work and the "Chinese pharmacopoeia" into the orbit of system revision work.
So far, China has enacted 10 edition pharmacopoeia, from scratch, contains standardized medicines from less to more, standard level from low to high, to improve the level of drug quality in our country, promote the transformation and upgrading of the pharmaceutical industry has played an important role. The past pharmacopoeia commission has been instrumental. We have vigorously improved drug safety standards and enhanced drug safety supervision. In recent years, there have been no major adverse drug incidents. These must be fully affirmed. But we also want to see, due to the limitation of historical condition, the industrial development started relatively late, weak government regulation ability, drug standards can not adapt to the need of regulation, and the people's expectation and gap. The effect of drug quality is different from that of the countries in the us and Europe, which is largely in the low market standard, and the market lacks the original research products as reference. Standards, standards, standards, and standards are not in place. We will conscientiously implement the general secretary about drug regulatory work important instructions, xi to speed up the standard system revision work, establish a scientific, comprehensive, inspection, can perform standard system, with "the most rigorous standards" improve the quality of drug curative effect, prevent drug safety risks, to lay a solid foundation for drug supervision work.
I hope to study some serious problems
At the time of the establishment of the new pharmacopoeia committee and the comprehensive launch of the pharmacopoeia in 2020, I would like to invite members of the pharmacopoeia committee to study several issues. These issues are of great significance for the development of standards, the revision of laws, the promotion of reform and the strengthening of supervision.
(I) study the positioning of pharmacopoeia work. The preparation of pharmacopoeia should carry out the development thought of the people as the center, serve the supervision of medicine, serve the reform and innovation, and serve the development of the pharmaceutical industry. The purpose of the preparation of pharmacopoeia is to encourage good medicines, weed out bad medicines and identify fake medicines.
(2) to study the essential characteristics of modern medicine and the essential characteristics of traditional medicine, as well as the difference between modern medicine and traditional medicine. Both the constitution of the People's Republic of China and the drug administration law have put forward the demands of the country to develop modern medicine and traditional medicine. To study the basic concept of modern medicine and traditional medicine, define its connotation and extension.
The concept of medicine has been around since ancient times. Each nation has its own traditional medicine in its history. The Chinese traditional Chinese medicine culture is extensive and profound, which plays an important role in the breeding of the Chinese nation and fighting the disease. To say that we have experienced the age of lack of medicine, mainly refers to the lack of modern medicine.
Modern medicine was introduced into China with modern medicine. The modern medicine is based on traditional medicine, combining with modern evidence-based medicine, and gradually perfecting the basic characteristics of today: based on the theory of medicine, chemistry, biology, etc. Generally, there are clear active ingredients, and the mechanism of its action is constantly studied. Through the clinical trials of a large random double-blind sample, the test data proved that it was effective for some indications, and the benefit of prevention or treatment of specific diseases of the patient's individual or human society was greater than the risk. Therefore, the drug review should be led by the clinical doctors. In addition, there are the production methods and processes approved by the regulatory authorities to ensure a uniform and stable quality. Comprehensive supervision of drugs, the drug marketing authorisation holder to fulfill the responsibility of the whole life cycle, post-marketing study, adverse drug reaction monitoring, and improve the knowledge of medicine, including drug instruction clearly, the side effects of taboo, matters needing attention, etc; A normative system for the continuous evaluation and withdrawal of listed drugs.
Traditional medicine is one of the traditional medical theory, under the guidance of the traditional preparation methods, dosage form and use of the traditional way, the traditional indications expression, traditional evidence-based method, has many years history, public recognition of drug use. Traditional Chinese medicine theory 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 clinical trial evidence of double-blind random large sample, the benefit is greater than the indication of risk, and the product is uniform and stable quality control. If modern medicine, modern pharmaceutical theory, modern preparation method and modern evidence-based method are used to study traditional medicine, the results should be declared, reviewed and regulated according to modern medicine. In recent years, we have made important achievements in researching and developing traditional medicine with modern medicine methods. The discovery of artemisinin, berberine and ephedrine, especially the discovery of artemisinin, is our significant contribution to human society. The study of treating leukaemia with arsenic trioxide is also a remarkable achievement. We have to be serious, summing up the experience of the natural medicine development research over the years, what are the clinical acceptance, internationally recognized achievements, and what are the lessons, go what detours, inherit the development of traditional medicine is of great significance to us.
(3) study the relationship between the standard of new drugs, the orange peel book and the pharmacopoeia. According to the concept and practice of modern drug regulatory, approved, an innovative drug is a drug approved standards, including the active ingredient, formulation and ways of medication, dosage forms, specifications, use, production process and process parameters as the enterprise business secret. These are also the regulatory basis for product listing. The enterprise must produce according to the approved standard, the data of the whole production process should be true, complete, timely recorded, can be traced back, otherwise, it will be the adulteration medicine. The new drug, which has been approved by regulators, is original and benchmarking, and its patent application is protected by patent law. Patent expires, the enterprise listed can borrow the original declaration of generic drugs production enterprise of results and data, from a large sample of clinical trials, a new regulatory review by the original drug standard equivalence and bioequivalence of the pharmacy, the equivalent effect shall be deemed to be equivalent, can replace each other in clinic. The approved version of the original drug used for reference is loaded into a catalogue and updated in time, which is the international Orange Book system. We also need to establish China's Orange Book system. We need to examine the role of the standard, the Orange Book and the pharmacopoeia of approved listed drugs.
The compilation and revision of pharmacopoeia, in a certain sense, is the reexamination and confirmation of the listed drugs. During the preparation of pharmacopoeia, the content of the collection, update and revision shall be verified by authenticity, reliability and scientific nature, and the safety, effectiveness and quality control of the contents shall be evaluated. In the case of authenticity, reliability, scientific doubt, safety, effectiveness and quality control, it is important to make Suggestions and Suggestions to the regulatory authorities; For medicines that have not been produced for many years, the Suggestions and Suggestions shall be put forward. In the years after the ipo, there is no adverse reaction monitoring, the adverse reaction of unknown medicines should also be put forward to deal with opinions and Suggestions. The committee is responsible to the public and is the responsibility of the commission.
(4) to embody the reform results in the revision of pharmacopoeia and 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 jointly promoted the reform of the examination and approval system with relevant departments. Reform has not been limited to review and approval, and gradually expanded into a comprehensive reform of drug regulatory system.
Why reform? The first is the basic solution of drug accessibility, but there is a gap in quality. Second, there are problems in the development, production and distribution of drugs. The phenomenon of unreal and incomplete data in r&d; In the process of production and processing, the phenomenon of unauthorised modification of process, adulteration, and cutting corners is incomplete, untruthful, unreliable and untraceable. The phenomenon of exaggerating propaganda and unscientific basis in the process of distribution is not uncommon. Third, the review and supervision are weak. Compared with the rapid development of the pharmaceutical industry, our supervisors have a severe shortage of staff, lack of capacity, difficulty in implementing effective supervision, and many loopholes. The problem of existence is recognized, but it is difficult to solve, and it is not enough. Four is to apply for a backlog, inefficient. This is the inevitable result of the first three questions.
How to reform? The CPC central committee and the state council have made a series of major decisions. In August 2015, the state council issued the opinions about drug review of medical equipment examination and approval system reform "(guo fa [2015] 44), approved by the standing committee of the National People's Congress in November 2015 in 10 provinces and municipalities to carry out the drug marketing authorisation holder system pilot, in February 2016 issued by the general office of the state council concerning the evaluation opinions of generic quality and curative effect of consistency" (countries do hair [2016] no. 8), issued by the state council in February 2017, "" much starker choices-and graver consequences-in" national drug safety planning "(guo fa [2017] no. 12), in July 2017, the central comprehensively deepen reform leading group reviewed and adopted the" about deepening the review of the opinions of the examination and approval system reform to encourage pharmaceutical medical equipment innovation ". With the approval of the state council, we have joined the international association of drug registration technology (ICH) and the next step is to join the international drug certification cooperation organization (PIC/S).
The overall goal of reform is to integrate with the world. The basic standard of drug listing is that the new drug should be "global", and the generic drug should be consistent with the quality of the original drug. To study ways to establish drug data protection system, patent compensation system, drug approval, and patent link system, patent dispute resolution in the drugs listed before, should encourage drug innovation, make the innovators motivated; It also encourages imitation, reducing the cost of generics and legal risks. Clinical leading team to establish a review system, communication with the applicant meeting system, contact the project administrator system, system of expert consultation committee openly demonstrate significant controversy, the review conclusion and basis to the social public system, to ensure that the review of a fair and just. In order to realize the whole life cycle management of drugs, we should realize the supervision of drug development, processing, distribution and use of the whole chain. The holder of the drug approval document shall bear the legal responsibility for the whole life cycle of r&d, processing, distribution, adverse reaction monitoring and improving the quality of the drug. The clinical trial data is not true, incomplete, and untraceable application, will be returned. The production and processing process violates the GMP specification, the data is not real, incomplete and untraceable, should be dealt with seriously, and the result is open to the public. For serious offenders such as counterfeiting, criminal responsibility shall be investigated according to law. In order to establish a system of confidential business secrets for the reviewers, inspectors, inspectors and law enforcement officials, the system of information system for drug review and evaluation shall be established. Staff members are strictly prohibited to seek for privacy, to check their personal interests and to make private use of business secrets. Ensure regulatory authority through the implementation of confidentiality obligations to the people.
The reform will include the examination and approval of future listed drugs, and the evaluation and clean-up of previously approved listed drugs. The time limit for the evaluation is to be refunded. Long-term production, not to change the process, not after the performance of the listed research and pharmacovigilance responsibility stability problems of effectiveness, safety, quality, to clean up and rectify, serious nature to be delisted. To study the criteria, conditions and procedures for drug delisting.
The new edition of the pharmacopoeia is in a critical period of reform and there will be many changes. The preparation of pharmacopoeia should implement a series of requirements of the CPC central committee and the state council on the examination and approval of drugs and the reform of drug regulatory reform, and reflect the results of the reform and timely reflect the improvement of the quality of medicine. It is hoped that every member of the new pharmacopeia committee will be rigorous, scientific, fair and objective and actively participate in the reform, reform and service reform. Each of our pharmaceutical practitioners, pharmaceutical researchers, and regulators are participants and facilitators of reform. It is in the interest of the general public to promote public health and promote it. If it is not in the interests of the people and is not conducive to promoting public health, it is necessary to give up. All our work must stand the test of history. While transforming the objective world, we should also transform our subjective world, learn new knowledge, master new skills, innovate institutional mechanisms, and strengthen capacity building.
(5) to study how the pharmacopoeia has developed the "hidden rules" service for cracking down on adulteration and counterfeiting, to serve as a regulatory service. There is a phenomenon in the pharmacopoeia of which indicators are examined, and some people have studied how to cheat the adulteration methods of these indicators. Please join your expertise to study how to solve this problem, plug the loopholes in time, and crack the "hidden rules".
Three, make several demands
The pharmacopoeia commission is the most authoritative technical institution in the field of pharmacy in China, and undertakes the sacred mission of national drug standards entrusted by the party and the state. The establishment of pharmacopoeia is the modern "suspenseful" of the work. The 11th annual pharmacopoeia commission was formally established today, and as a member of the national pharmacopoeia, it is not only the honour of clanging, but also the heavy responsibility. Each member of our pharmacopoeia should place the mission and responsibility in mind, and complete the preparation of pharmacopoeia in a highly responsible spirit.
First, stick to the scientific attitude. Members come from different fields and professions, to respect each other, to learn from each other, to learn from each other, and to discuss on equal terms. With scientific rigour, pragmatic attitude and innovative spirit.
Second, take responsibility. Every standard revision will encounter various contradictions, difficulties and problems, and any choice may have different opinions. We should take the interests of the people, the public health as the basic starting point, dare to face the problem, have the courage to bear, dissolve the work problem, make "not the kui on day, open and aboveboard and feel no qualms over to job performance.
Third, strengthen institutional construction. Revised standard work rules and regulations, perfect the standard work procedures, set up a withdrawal system for conflicts of interest, public demonstrate significant gaps system, public response was not substantial adopted system, democratic decision-making, scientific decision-making, public decision-making, accept social supervision.
Fourth, uphold the integrity of non-corrupt work ethic. The amendment standard is to fulfill the public power of the state. Members of the pharmacopoeia must abide by the laws and disciplines of the state employees. Party members in the executing process, but also the spirit and to comply with the requirements of the central eight members of the discipline, spirit of non-party people committee should also be in accordance with regulations of the central eight strict with myself, stick to principles, not to confused by interests, was not swayed by personal relationship. If there is any violation of national laws and professional ethics, the result shall be investigated and handled publicly.
Members and comrades, the responsibility of drug standards is important and the mission is glorious. We have to unite more closely around the party central committee with comrade xi as the core, adhering to the people as the center of the development of ideas, earnestly implement the "four most strict" requirements, with a more scientific standard to ensure drug quality, support drug regulation, leading the industry development, with excellent can stand the historical inspection work, make new contribution for the Chinese nation's health.
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