[exclusive] a brief history of the evolution of China's drug registration system (3): the birth of new drug approval measures

In 1984, the seventh session of the Sixth National People's Congress passed the drug administration law of the people's Republic of China The birth of China's first drug administration law marks the beginning of a new stage in the legalization of drug registration in China Article 21 and 22 of the drug administration law stipulate that in the development of new drugs, relevant data and samples such as the development method, quality index, pharmacological and toxicological test results must be submitted to the health administration department under the State Council or the provincial health administration department in accordance with the provisions, and the clinical test or clinical verification can only be carried out after approval A new drug that has completed clinical trials or clinical verification and passed the appraisal shall be approved and issued a certificate by the administrative department of health under the State Council The production of new drugs must be approved by the administrative department of health under the State Council, and an approval number shall be issued However, the production of Chinese herbal pieces is excluded For the production of drugs with national standards or standards of provinces, autonomous regions and municipalities directly under the central government, the health administrative departments of provinces, autonomous regions and municipalities directly under the central government must seek the opinions of the departments in charge of drug production and marketing at the same level before examination and approval, and issue the approval number However, the production of Chinese herbal pieces is excluded [1] 1 In the brief history of the evolution of China's drug registration system (2), the promulgation and editor of the new drug approval measures in 1985 mentioned that due to the implementation of the new drug management measures (Trial Implementation) in 1979, its formulation is relatively principled and there is no specific technical requirements, so there is confusion in the process of new drug approval In order to solve this problem, since 1980, the Ministry of health has organized a drafting group to start revising the new drug management measures In the six-year revision process, the drafting group held three professional symposiums in total, including 7 front and back revisions, 3 National requests for comments, and one symposiums for comments by the director of National Drug Administration and the relevant production and scientific research personnel of the pharmaceutical administration In 1981, a new drug investigation team was organized to investigate the new drug management in the United States and Japan During this period, the drug administration law was drafted, and the new drug approval measures were originally planned to be issued and implemented in 1983 However, due to the promulgation of the drug administration law, it was postponed to 1985 [2] On July 1, 1985, the new drug examination and approval measures formulated and officially promulgated by the Ministry of health in accordance with the drug administration law of 1984 finally came late The first special drug registration law was born, marking that the management and approval of new drugs in China has entered the stage of legalization The new drug approval method has re combed the definition and classification of new drugs, and made more systematic and detailed regulations on clinical trials, safety and effectiveness evaluation of various new drugs and related technical requirements, as well as approval and production that must be submitted before the application for production of new drugs, thus establishing a relatively complete new drug approval procedure New drugs shall be subject to centralized and unified examination and approval by the Ministry of health, and the provincial health administrative departments shall be the preliminary examination units The clinical research of new drugs shall be transferred to the Ministry of health for approval after the preliminary examination by the provincial health administrative department, and the clinical research of the fourth and fifth new drugs shall be copied to the Ministry of health for filing after the provincial examination and approval The revised terms withdraw the power of provincial examination and approval of clinical research Although the concentration of drug approval authority may affect the speed and quantity of new drug development, the quality and threshold of new drug review and approval have been greatly improved To a certain extent, it curbs the confusion of drug approval In 1985-1999, a number of supplementary provisions were issued on the basis of the measures for the examination and approval of new drugs, and the provisions on the protection of new drugs and technology transfer were implemented as of March 24, 1987 In 1988, the Ministry of Health issued several supplementary regulations on the administration of new drug approval, which further improved the approval of new drugs On January 7, 1989, the State Council approved the measures for the implementation of the drug administration law of the people's Republic of China On September 25, 1989, the Ministry of Health issued the notice on Several Issues concerning the application for approval of new drugs On April 1, 1992, the Ministry of health again issued the notice on several issues of drug examination and approval management At the same time, it also made Supplementary Provisions on traditional Chinese medicine and biological products The new drug examination and approval method was implemented from July 1, 1985 to April 30, 1999, with a period of nearly 14 years Hongmao medicinal wine, which has a lot of controversy in the front-end time, was approved for listing during this period According to the information disclosed by the former State Food and Drug Administration (CFDA), Hongmao medicinal wine is the exclusive variety Now the approval holder is "Inner Mongolia Hongmao Pharmaceutical Co., Ltd." which was approved and registered by the former Health Department of Inner Mongolia Autonomous Region on October 16, 1992 The original approval number is "internal health medicine standard" Zi (86) i-20-1355 " In 2002, the original State Drug Administration issued a unified change of approval number, which was "gyzz15020795" After that, it was re registered twice by the food and Drug Administration of Inner Mongolia Autonomous Region, and now the approval number is valid until March 18, 2020 Hongmao medicinal wine is an exclusive product, which was listed in 1992 In theory, it should be registered in accordance with the provisions of the measures for the approval of new drugs The procedures for the approval and production of new drugs are as follows: after the completion of clinical research on new drugs, if it needs to be produced, the research and development unit must apply to the Department (bureau) of health of the province, autonomous region and municipality directly under the central government where it is located, submit relevant data and samples, and transfer them after examination and approval It shall be submitted to the Ministry of health for examination and approval, and a new drug certificate and approval number shall be issued New drugs without approval number shall not be produced However, it is a big question why Hongmao medicinal wine was approved and registered by the health department of Inner Mongolia Autonomous Region, and the approval number obtained is nwyzz (86) i-20-1355 2 In 1999, the State Drug Administration issued the revised "new drug approval measures" in August 1998, the State Drug Administration (SDA) was officially established With the passage of time, there are still some problems in guiding and standardizing the development and approval of new drugs in China, which can not effectively meet the needs of the supervision and management of new drug approval and the development of China's pharmaceutical industry at that time In order to strengthen the supervision and administration of drugs and the administration according to law, the State Drug Administration organized the revision of the measures for the examination and approval of new drugs On May 1, 1999, SDA officially promulgated 5 laws and regulations, including the measures for the approval of new drugs, the measures for the approval of new biological products, the measures for the administration of imported drugs, the measures for generic drugs, and the provisions for the protection of new drugs and the transfer of technology In 1999, the new drug approval method defined new drugs as "new drugs refer to drugs that have not been produced in China" Before the promulgation of the method, chemical drugs were called "western medicine" Until the implementation of the method, the term "chemical drugs" was used and has been used up to now In addition, the drug approval number is standardized, and the format of the new drug trial production approval number is "Guoyao trial word x (or Z) ××××××××" After the trial production is converted to formal production, the official production approval number shall be issued in the form of "gyzz x (or Z) ×××××××" Where x stands for chemicals, Z stands for traditional Chinese medicine; the first four digits after the letter are the year of AD For the first time, the new drug examination and approval measures put forward the procedures for accelerating the review, among which, for the first class of chemical drugs and the first class of new traditional Chinese medicine drugs that meet the provisions of Article 26 and Article 27, the secret level of traditional Chinese medicine has been determined according to the national confidentiality law to change the dosage form, or to add new varieties of indications, as well as for the first new drug in China to apply for clinical research and the first in China to apply for doubt For new drugs with therapeutic effect for critical and difficult diseases (such as AIDS, tumor, rare disease, etc.) and traditional Chinese medicine with unique preparation process, the research and development unit can directly apply to the State Drug Administration, which shall speed up the review progress and timely review Many clauses in the measures for approval of new drugs refer to the international common practice, marking the innovation of new drug approval management in China, which is gradually in line with international laws and regulations [3] From May 1, 1999, the measures for examination and approval of new drugs came into effect Until December 1, 2002, the measures for the administration of drug registration (for Trial Implementation) began to be implemented, and the measures for examination and approval of new drugs was abolished, with a total implementation period of three years and seven months In order to solemnly commemorate the 40th anniversary of reform and opening up, to record the hard course of Chinese pharmaceutical enterprises' pharmaceutical research and development in the past 40 years; to record the Chinese pharmaceutical people's spirit of striving for the development of Chinese pharmaceutical industry, the big data of Chinese pharmaceutical research and development in the past 40 years, which was created by pharmaceutical intelligence network and China Pharmacy magazine, will be published soon 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, publication and distribution of "China's pharmaceutical R & D 40 years big data" is the common vision of the Chinese pharmaceutical industry and Chinese pharmaceutical people, which requires more powerful 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? Click https:// ﹣ QDH to enter the special page to participate in the discussion ~ reference [1] Drug Administration Law of the people's Republic of China [1984] [2] Fu Junyi Notes on the formulation and implementation of new drug approval measures [J] Chinese Journal of clinical pharmacology, 1991 (03): 129-134 [3] Zhang Xiaofa Historical change and analysis of drug registration and approval system in China [J] Chinese Journal of traditional Chinese medicine, 2009,34 (20): 2685-2688