[exclusive] a brief history of the evolution of China's drug registration system

Introduction: in the past 40 years of reform and opening up, China's pharmaceutical industry has been growing at a high speed, but it has also accumulated many problems In order to eliminate the accumulated disadvantages, the new policy of medicine was implemented in 2015, making people in the pharmaceutical industry realize the past shortcomings, and the whole industry has a huge change from concept to technology The pain brought by the strong promotion of generic drug consistency evaluation in the new policy to enterprises is huge Why does society and enterprises need to spend a lot of money to pay for the re research of listed products? How were these products approved for marketing in those years? What other varieties need to be reevaluated? The author tries to sort out the evolution of drug registration system since the founding of the people's Republic of China, and find the answer from this perspective The first comprehensive regulation of drug administration since the founding of new China in 1963: Some Provisions on Drug Administration (Draft) as the saying goes, no rules do not make perfect, but the management of drugs, especially the registration management of drugs, is not so At all times and in all over the world, drugs are basically treated as ordinary commodities Management is very loose It is unnecessary to approve what you want to produce Until modern times, when you realize the particularity of drugs, relevant laws and regulations began to exist In the early days of the founding of the people's Republic of China, the pharmaceutical industry was under the leadership of the Ministry of health Since the mid-1950s, the pharmaceutical production has entered the period of planned management In terms of production, who will produce and what will be produced are mainly determined by the government's plans The pharmaceutical industry was transferred to the Ministry of light industry in 1962 and under the leadership of the Ministry of chemical industry in 1956 In 1964, the Ministry of chemical industry established the China Pharmaceutical Industry Corporation, which is responsible for the production of drugs In 1963, the Ministry of health, the Ministry of chemical industry and the Ministry of Commerce jointly issued several provisions on Drug Administration (Draft), which is the first comprehensive regulation of drug administration since the founding of new China In the aspect of new drug research and development, the second chapter of the draft stipulates the management principles of new drug products, which are clearly confirmed from the definition of new products, the establishment of drug approval committee, the approval procedures of new products, the approval of clinical and production, and which kind of drugs belong to the approval of the Ministry of health In addition to the R & D and production of products by pharmaceutical factories and scientific research institutions, in the era of drug shortage, hospitals also carry out their own R & D and production of drugs, even injection, a high-risk preparation, is no exception In fact, in China, until 2000, there were many kinds of large-scale infusion produced by hospitals for their own use With the forced promotion of GMP, large-scale infusion produced by hospitals was completely cancelled "Excellent county hospital, yuncheng county people's Hospital of Shanxi Province, more than 370 kinds of pills and injections have been self-made in recent years!" photo source: the first special regulation on new drug products since the founding of new China in 1965 by Shanghai Medical Literature Museum of the Republic of China: Interim Measures for the management of new drug products (Draft) In 1965, the Ministry of health and the Ministry of chemical industry jointly issued the Interim Measures for the administration of new drug products (Draft) After one year's investigation in 1964, according to the Several Provisions on the administration of drugs (Draft), the measures made more specific provisions on the administration of new drugs It is the first drug new product management method implemented in China, which provides the definition of new drugs and clinical practice specific requirements for production approval But as soon as the law was introduced, the Cultural Revolution began During the ten-year turmoil, there was another chaotic situation of running drug factories and manufacturing drugs indiscriminately Laws and regulations were not implemented, and a large number of "new drugs" were donated during this period After the establishment of the State Administration of medicine at the Third Plenary Session of the Eleventh Central Committee, the State Administration of medicine and the Health Bureau, together with relevant departments, began to rectify the pharmaceutical factories and re approve the varieties produced In June 1979, the State Council approved and transmitted the report on the work of rectifying pharmaceutical factories in the whole country issued by eight ministries and commissions including the Ministry of health and the State Administration of medicine The Ministry of health and the State Administration of medicine formed a leading group for rectifying pharmaceutical factories, comprehensively rectifying the pharmaceutical production units in the whole country from the top to the bottom, stopping the unhealthy trend of disorderly running pharmaceutical factories and illegally manufacturing and selling drugs The health departments of all provinces, cities and autonomous regions At the same time of rectifying the pharmaceutical factories, we carried out a comprehensive cleaning up of drug varieties, registered and rechecked the drugs produced in the region one by one, fulfilled the examination and approval procedures again, compiled the approval number, and strengthened scientific management All localities also evaluated the clinical efficacy and, on the basis of extensive consultation, applied to the Ministry of health for the list of drugs recommended to be eliminated, which totaled 517 varieties In September 1982, the Ministry of Health announced the elimination of 127 varieties with unclear curative effect, serious side effects and unreasonable formula This period is also a good time for "R & D" of traditional Chinese medicine injections There is not a single traditional Chinese medicine injection included in the 1963 Chinese Pharmacopoeia, but there are 24 traditional Chinese medicine injections included in the 1977 Chinese Pharmacopoeia, most of which have stopped production, and only a few are still in production and sale, such as zedoary turmeric oil injection, ligustrazine hydrochloride injection, Yinhuang Injection, etc The varieties of traditional Chinese medicine injections included in 1977 edition of Chinese Pharmacopoeia are as follows: due to the limitation of historical conditions, there are some problems in the R & D and production of new products, but after 30 years of construction, China has gradually established a certain scale and relatively matching pharmaceutical industry system By 1979, there were more than 330 pharmaceutical factories and more than 80 Chinese patent medicine factories in the pharmaceutical industry system China has been able to produce more than 1000 chemical APIs, 3000 preparations and more than 3000 specifications of Chinese patent medicine China has stepped into the period of reform and opening up In the face of the coming stage of rapid development and the lack of supervision and guidance in the application and registration of new drug products, what laws and regulations have been issued to regulate it? What kind of impact does it have on the research and development of new drugs in China? Please look forward to "a brief history of the evolution of China's drug registration system (2):" new drug management measures "issued" References: 1 Reform and development of China's pharmaceutical system by Wei Jigang; press: Commercial Press; 2 General history of China's medicine; 3 Research on the historical evolution and current situation of current measures for the administration of drug registration by Zhao Yue and Chen Yongfa; 4 Chinese Pharmacopoeia, 1963, 1977; 5 Pharmaceutical Yearbook, 1949-1979 For further reading, please click: a brief history of the evolution of China's drug registration system (2): the introduction of new drug administration measures (Trial) in 1979 In order to solemnly commemorate the 40th anniversary of reform and opening up, record the hard course of Chinese pharmaceutical enterprises' pharmaceutical research and development in the past 40 years; record the Chinese pharmaceutical people's spirit of striving for the development of Chinese pharmaceutical industry, and publish the big data of China's pharmaceutical research and development in the past 40 years, which is made by the pharmaceutical intelligence network and China Pharmacy magazine 。 This book will show the reform, progress, achievements and problems in the field of Chinese pharmaceutical research and development in the 40 years of reform and opening up in a panoramic and epic way, and comprehensively analyze the trend of future pharmaceutical research and development from the perspective of globalization in the new era, so as to draw a prospective vision for the next step of Chinese pharmaceutical research and development The compilation, publishing and distribution of "China's pharmaceutical R & D big data in the past 40 years of reform and opening up" is the common vision of the Chinese pharmaceutical industry and Chinese pharmaceutical people, which requires more competent and responsible units and individuals to invest and support What do you think of the 40 years of reform and opening up in China's pharmaceutical research and development? 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