Improve the re evaluation level of traditional Chinese medicine after being put on the market to ensure the safety of public drug use

On June 6, the fourth advanced seminar on post marketing reevaluation and pharmacovigilance of traditional Chinese medicine was held in Beijing, sponsored by the professional committee of post marketing reevaluation of traditional Chinese medicine of the World Federation of Chinese Medicine Societies At the meeting, three technical specifications continuously revised in the process of practice were passed and served as the standards of the professional committee Experts pointed out that: technical specifications were implemented to improve the level of re evaluation In recent years, the safety evaluation standard of traditional Chinese medicine injection has become the focus of the industry In this regard, the World Federation of China Special Committee for post marketing reevaluation of traditional Chinese medicine deliberated and passed three technical specifications for post marketing reevaluation of traditional Chinese medicine, which will be of great significance to the protection of public drug safety The standard is the guarantee of quality and safety On June 6, the World Federation of Chinese medicine post marketing reevaluation Professional Committee deliberated and approved in principle the two industry organization standards of technical specifications for centralized monitoring of safety hospitals after TCM listing and technical specifications for pharmacoeconomic evaluation after TCM listing, as well as the draft of technical specifications for centralized monitoring report of safety hospitals after TCM listing The formulation of technical specifications is of great significance to improve the re evaluation of traditional Chinese medicine after it is put on the market and to ensure the safety of drug use by the public Li Zhenji, vice chairman and Secretary General of the World Federation of Chinese Medicine Societies, said that traditional Chinese medicine injection is a breakthrough innovation in the form of traditional Chinese medicine for thousands of years More attention should be paid to and research should be strengthened to make it develop healthily and healthily Pharmacovigilance is a scientific activity to discover, evaluate, understand and prevent adverse drug reactions or other drug-related problems As a member of the World Health Organization international drug monitoring cooperation program, China is committed to actively strengthening exchanges and cooperation with the World Health Organization and other countries, introducing advanced management concepts and methods, and providing more scientific services for the public's drug safety Li Zhenji pointed out that it is very important to study the criteria of reevaluation after the listing of traditional Chinese medicine, first of all, the needs of industry and enterprises, second of management departments, and third of society The accumulation of objective drug data is very important, and re evaluation is conducive to drug management The support of technical specifications can make the re evaluation of traditional Chinese medicine more rigorous and scientific The standardization of traditional Chinese medicine is of great significance Sang Binsheng, director of the Department of policies, regulations and supervision of the State Administration of traditional Chinese medicine, pointed out that standardization has seven functions and significance for the development of traditional Chinese medicine First, standardization is an effective way to promote the academic development of traditional Chinese medicine The standard is a kind of innovation, a kind of collective innovation, which can make the research results of fragmentation, gather ancient and modern, transform it with standard method, optimize it, and integrate it Secondly, standardization is an effective way to maintain and give full play to the advantages of traditional Chinese medicine The diagnosis and treatment of traditional Chinese medicine is a repetitive business, which needs to be regulated uniformly, but the standard does not exclude individuality The standard is a summary of common laws On the basis of giving full play to individuality, the law is summarized at a new level Standardization and individuality are not contradictory Third, standards are an important means of industry management Fourth, standards are the basic guarantee of quality and safety Fifth, standardization is an effective way to promote the achievements of traditional Chinese medicine Sixth, the standard is an important way to modernize traditional Chinese medicine Seventh, the standard is an urgent need for the international dissemination of traditional Chinese medicine Sang Binsheng introduced that the State Council issued the reform plan for deepening standardization work in April this year One of the highlights of the plan is the group standard "In the past, China's standardization management was divided into four levels of standards, national standards, industry standards, local standards, enterprise standards, without group standards The group standard has not been determined in laws and regulations This reform has joined the group standard, which can give full play to the main role of the market in resource allocation and adapt to the new needs and changes of the market " The formation of international mature mode forces Xie Yanming, deputy director of Clinical Basic Medicine Research Institute of Chinese medicine, Chinese Academy of Sciences, and Secretary General of the World Federation of Chinese medicine post market re evaluation professional committee, to introduce that there are limitations in the pre Market Research of drugs, and post market re evaluation is an important supplement and improvement before the market In the whole life cycle of drugs, pre marketing research and post marketing re evaluation are two important stages Compared with the current situation of post marketing reevaluation of international drugs, China's Drug Reevaluation work started late and has not yet formed a relatively complete post marketing reevaluation system Among them, the post marketing reevaluation of traditional Chinese medicine, due to its complex and diversified composition, the complexity of clinical practice of traditional Chinese medicine treatment scheme and clinical trials The uncertainty of influencing factors and the dynamic of TCM syndromes are significantly different from the re evaluation of Western medicine With the development of modern science and technology, the developed countries have formed a more standardized and perfect management mode for the research and development, approval, production, circulation, sales, operation and use of drugs In the aspect of post market re evaluation of drugs, the organizations or countries represented by who, the United States and the European Union have also established more mature management methods, all of which have established a post market re evaluation system for Chinese traditional medicine The formation of backpressure mechanism makes us have to pay attention to the severe international situation faced by the re evaluation after the listing of traditional Chinese medicine In view of the drug safety problems of the world's people, who has issued a series of regulations and guidelines, mainly including pharmacovigilance: ensuring the safety of drug use, the importance of pharmacovigilance: drug safety monitoring, drug safety: WHO guidelines for the inspection and reporting of adverse drug reactions, and adverse drug reactions after marketing Who pharmacovigilance system herbal safety monitoring guide is aimed at monitoring the safety of herbal medicine, which is recognized by most countries, and it is an important reference for many countries to formulate the regulations of re evaluation after drug listing For a long time, the United States has attached great importance to the re evaluation of drugs after they are put on the market, especially the re evaluation of safety The fifth part of the federal food, drug and cosmetics law has made detailed requirements for the supervision of drugs; the food and Drug Administration 2007 Amendment Act has effectively promoted the development of drug vigilance and risk management in the United States The control of plant medicine in the United States is listed as dietary supplement for management In 2002, traditional Chinese medicine was listed as one of the complementary and alternative medicine systems, and the regulations and guidelines related to herbal medicine were also relatively sound There were food and drug law, prescription drug listing law, etc., among which the FDA in the guiding principles of plant medicine development The requirements for preclinical research of botanical drugs have been relaxed After clinical application and approval, the botanical drugs can be directly entered into clinical development in the United States If the safety and effectiveness of the botanical drugs are confirmed through comparative clinical trials, they can be approved as new drugs by FDA EU countries attach great importance to the safety of post marketing use of drugs In Europe, traditional Chinese medicine is classified as traditional plant medicine As early as 1988, the original European Community formulated the "guidelines for the management of herbal products" to clearly define the concept of herbal medicine In 1990, the "Regulations for the quality management of pharmaceutical production" of herbal medicine was proposed The traditional medicine law issued in 2004 emphasizes that since 2004, traditional herbal medicine products have been used in EU member countries for more than 15 years Meanwhile, it provides evidence that the products have been used in countries or regions outside the EU for more than 30 years, and the products need to meet the drug quality standards They can be sold and used in EU as traditional medicines through registration There are some deficiencies in the existing policies and regulations The post market re evaluation started late in China, and the relevant policies and regulations have been issued successively Xie Yanming believes that in different stages, there are certain problems in each corresponding law and regulation In 2001, the drug administration law of the people's Republic of China and the regulations for the implementation of the drug administration law of the people's Republic of China were issued, which stipulated the post market drug reevaluation system in principle and provided the legal basis for the legislation of post market drug reevaluation Its deficiency lies in its incompleteness and limited operability, and there is no detailed implementation method and management measures to support the corresponding legal provisions In 2004, the management measures for adverse drug reaction report and monitoring was issued, which made relatively detailed regulations on adverse drug reaction monitoring, but the operability of solving practical problems was still not strong, such as the lack of clear regulations on the investigation and treatment of serious adverse events and the requirement of enterprises to conduct safety research on drugs on the market In 2007, the administrative measures for drug recall was issued, which pointed out the investigation and evaluation of drug safety hazards, and provided the corresponding recall system to supervise the drug circulation, but the supervision of the recall system and circulation was insufficient Since the occurrence of "Houttuynia" injection, "Ciwujia" injection, "Xiangdan" injection, "Shuanghuanglian" injection and other adverse events, the State Food and drug administration has issued relevant regulations on re evaluation of traditional Chinese medicine injection In 2009, the guiding principles for clinical trials after drug listing (Draft) was issued, which filled in the gap of legal basis for re evaluation of drugs after drug listing in China and laid the foundation for re evaluation of laws and regulations It focuses on the basic principles of post market evaluation, but it is more general and gives the post market clinical trials in principle There is no specific method for how to manage and how to operate the clinic In 2010, "seven technical guidelines for safety re evaluation of traditional Chinese medicine injection (Trial)" was issued, which made detailed provisions for quality and safety assurance of traditional Chinese medicine injection 7 technical guidelines related to production process , quality control, non clinical research, clinical research, risk control, risk benefit evaluation, risk management plan, etc However, the content is relatively broad, and there are no clear provisions on the content, implementation method, work plan and clinical operation technical specifications of re evaluation after the Chinese medicine injection is put on the market, which makes the research content of the Chinese medicine injection after it is put on the market generalized There is no evidence for enterprises and researchers to carry out relevant research on re evaluation of traditional Chinese medicine injections after they go on the market In 2011, the measures for the administration of ADR report and monitoring was issued, which is applicable to drug production, trading enterprises and medical and health institutions in China, standardizing the management of ADR report and monitoring, further promoting the development of ADR monitoring work, and providing a strong guarantee for the effective control of drug risks "But there is still a lack of supporting management regulations, and the re evaluation of safety of traditional Chinese medicine after marketing has been paid more and more attention by the state and the community." Xie Yanming suggested that in the future, we should establish and improve the ADR monitoring technology system, gradually expand the monitoring scope, and further improve the monitoring quality According to the development of current international drug re evaluation technology, combined with the characteristics of Chinese traditional medicine re evaluation itself, based on international standards, using modern cutting-edge methods, it is an arduous and urgent task to form a systematic and universal technical specification of post market clinical re evaluation of traditional Chinese medicine The transformation of scientific research results into technical specifications and technical specifications is an important technical guidance document to guide the orderly development of re evaluation work after the listing of traditional Chinese medicine Professor Weng Weiliang, chief researcher of the Chinese Academy of traditional Chinese medicine, and other experts pointed out that the major special project "major new drug creation" and "key technology for re evaluation of traditional Chinese medicine after being put on the market" -- re evaluation of clinical safety of traditional Chinese medicine injections in the implementation process, conscientiously implement the national laws and regulations for post market monitoring of drugs and have a high academic level