What policies did China's pharmaceutical industry introduce in 2018?

[policies and regulations of China Pharmaceutical network] 2018 is about to pass What happened to the pharmaceutical industry in this year? In this regard, the author reviewed the key policies issued at the national level in the pharmaceutical industry this year In November, the trusteeship of public hospital pharmacy was stopped On November 26, the state health and Health Commission and the State Administration of traditional Chinese medicine jointly issued the opinions on accelerating the high-quality development of pharmaceutical services It is suggested that public hospitals should adhere to the public welfare nature of pharmacies, and public hospitals should not contract or rent pharmacies, nor entrust pharmacies to profit-making enterprises In October, the 2018 edition of the national basic drug catalog was released On October 25, the national health and Health Commission officially released the national basic drug catalog (2018 Edition), which will take effect on November 1 The new version of the list of basic drugs is mainly adjusted and improved on the basis of the 2012 version of the list The number of varieties has increased from 520 to 685, including 417 western medicine and 268 Chinese patent medicine (including ethnic medicine), which can better serve all kinds of medical and health institutions at all levels, and promote the full allocation and priority use of basic drugs In September, opinions on improving the national essential drug system was officially released On September 19, opinions on improving the national essential drug system (hereinafter referred to as "opinions") was officially released Nine years later, the opinions made adjustments at the top level of design, and made institutional arrangements in the selection, production, circulation, use, payment, monitoring and other links of essential drugs, which clarified the future development direction of national essential drug system and policy In August, the work plan for the centralized treatment of the quality of Chinese herbal pieces was printed and distributed by the State Food and drug administration On August 31, the work plan for the centralized treatment of the quality of Chinese herbal pieces was printed and distributed by the State Food and drug administration Propose to severely investigate and deal with the illegal behaviors of Chinese herbal pieces; accelerate the improvement of the technical management system in line with the characteristics of Chinese herbal pieces, and organize the implementation stage (October 2018 September 2019) The drug regulatory authorities at all levels are required to intensify the investigation and punishment, not only to expose the illegal production and operation enterprises of Chinese herbal pieces, but also to expose the users of unqualified Chinese herbal pieces In dealing with illegal cases, we should not only punish the illegal production, operation and use units, but also investigate the responsibilities of the persons in charge and other persons directly responsible of the units according to law In August, the drug traceability system was launched On August 24, the State Food and Drug Administration issued the guiding opinions on the construction of drug information traceability system (Draft for comments) (hereinafter referred to as the opinions) According to the opinion, by the end of 2022, the full coverage of drug information traceability system will be basically completed Each province (District, city) can formulate implementation plan in combination with the actual supervision, and promote the construction of drug information traceability system step by step according to drug dosage form and category Key products and key enterprises shall be included in the traceability system, and priority shall be given to basic drugs, medical insurance reimbursement drugs and other products of general concern to consumers In August, we will strengthen the supervision of the quality of pharmaceutical consumables On August 23, nine ministries and commissions including the national health and Health Commission, the Ministry of industry and information technology, the Ministry of public security, and the Ministry of Finance jointly issued the notice on the key points of the special governance work for correcting the unhealthy tendencies in the field of pharmaceutical purchase and sale and medical services in 2018 (gwyh [2018] No 186) (hereinafter referred to as the key points) The "key points" first encourages enterprises to produce independently and strengthen the quality supervision of drug consumables For key areas such as high-value medical consumables and testing reagents, we should seriously investigate and punish unfair competition behaviors such as bundling drugs and medical consumables in the form of leasing or donation, or designating patients to purchase drugs and medical consumables from a third party without being included in the financial supervision of public medical institutions In July, accelerate the listing of imported drugs On July 10, the State Drug Administration issued the notice on technical guidelines for the release of overseas clinical trial data of drugs (No 52, 2018) (hereinafter referred to as the notice), which provides clear policy guidance for the work of accepting the applicant to use overseas clinical trial data as clinical evaluation data when applying for registration in China According to the requirements of the circular, the overseas clinical trial data involved, including but not limited to the clinical trial data obtained overseas by the applicant through the domestic and overseas simultaneous R & D of innovative drugs; the generic drug R & D conducted overseas with complete and evaluable bioequivalence data, can also be used for registration application In May, 19 varieties were under management On May 8, the State Drug Administration issued a notice saying that 18 kinds of drugs, including Banlangen effervescent tablets, were converted from prescription drugs to over-the-counter drugs according to the provisions of the measures for the classified management of prescription drugs and over-the-counter drugs (Trial) (Order No 10 of the State Drug Administration) and through the organization, discussion and approval of the State Drug Administration; Shangshi Zhitong plaster is no longer in line with the current principle of determining class B over-the-counter drugs It has been converted from class B over-the-counter drugs to class a over-the-counter drugs Relevant enterprises shall, before July 6, 2018, submit supplementary application for revising the drug specification according to the measures for the administration of drug registration and other relevant regulations In April, reform and improvement of supply guarantee and use of generic drugs On April 3, the state issued the opinions on reform and improvement of supply guarantee and use policy of generic drugs (hereinafter referred to as "opinions") The opinions aims to promote the research and development of generic drugs, improve the quality and efficacy of generic drugs, improve the ability of drug supply guarantee, better meet the needs of clinical medicine and public health and safety, and speed up the leap from a pharmaceutical power to a pharmaceutical power in China
Specifically, there are the following opinions, including the formulation of drug catalogue to encourage imitation, the enhancement of technological research on generic drugs, the improvement of intellectual property protection of drugs, the acceleration of quality and efficacy consistency evaluation of generic drugs, the improvement of quality of pharmaceutical raw materials and packaging materials, the improvement of process manufacturing level, the strict review and approval of drugs, the strengthening of drug quality supervision and timely It should be included in the procurement catalogue, promote the alternative use of generic drugs, give full play to the incentive role of basic medical insurance, clarify the path of compulsory drug licensing, implement preferential tax policies and price policies, promote the internationalization of the generic drug industry, and do a good job in publicity and guidance In March, the health insurance bureau, the health care Commission and the drug administration were established On March 13, the institutional reform plan of the State Council was announced According to the plan, after the reform, the number of institutions at the head and ministerial levels of the State Council decreased by 8, and that at the Deputy ministerial level decreased by 7 In addition to the general office of the State Council, the State Council set up 26 constituent departments Set up the National Medical Security Bureau Integrate the basic medical insurance and maternity insurance responsibilities of the Ministry of human resources and social security for urban workers and urban residents, the new rural cooperative medical service responsibilities of the national health and Family Planning Commission, the drug and medical service price management responsibilities of the national development and Reform Commission, and the medical assistance responsibilities of the Ministry of people's government, and establish the National Medical Security Bureau as an institution directly under the State Council 。 The national health and Health Commission, the State Administration of market supervision and administration, and the State Drug Administration shall be established separately under the administration of the State Administration of market supervision and administration.