[major events] medical policies and events in 2016

In 2016, the State Council issued the outline of strategic plan for the development of traditional Chinese medicine (2016-2030), which included the development of traditional Chinese medicine in the national development strategy; the CPC Central Committee and the State Council issued the outline of healthy China 2030, which determined the action plan for promoting the construction of healthy China in the next 15 years, until the end of the year, the first Chinese medicine bill of China was issued In 2016, the State Council issued the opinions on the evaluation of the consistency of quality and efficacy of generic drugs, which forced pharmaceutical enterprises out of the comfort zone of China's generic drugs (in particular, yaozhi.com worked together to create a database of orange peel Books); the State Council issued the key tasks of deepening the reform of medical and health system in 2016, which promoted the "two vote system" nationwide; CFDA issued《 The announcement on rectifying the illegal operation in the field of drug circulation has opened up the national circulation renovation; the Hebei Provincial atmospheric office issued the air pollution prevention and control No.2 dispatching order, and the environmental problems made the drug companies wear a tight hoop curse; CCTV exposed that drug bribery, medical anti-corruption, and business units anti-corruption in-depth; the hospital public to private, 500 public hospitals disappeared or are disappearing .. In 2016, the U.S FDA approved 22 original new drugs, including 15 new molecular entities and 7 new biological products Compared with the 33 new molecular entities and 12 new biological products approved in 2015, the total number of approved new drugs dropped 51% year-on-year... 2016 is bound to be an extraordinary year What major events have taken place in the pharmaceutical industry in this year that deserve our attention? What important policies, regulations and documents have been issued? The author has made a selection and integration for you, as follows: ([inventory] summary of major events in the first half of 2016) Click to see Table 1: key policies and regulations in the second half of 2016 and analysis of the time of promulgation summary of key points on December 30, the 31st meeting of the leading group of comprehensive deepening reform of the Central Committee was approved Several opinions on further reform and improvement of drug production, circulation and use policies emphasize the implementation of "two vote system reform" of drug circulation, purification of drug circulation and solution of outstanding problems On December 29, the official website of the Ministry of Commerce issued the national development plan for drug distribution industry (2016-2020), and by 2020, a number of large-scale drug distribution enterprises with a high degree of network coverage, intensification and informatization will be cultivated The annual sales of the top 100 drug wholesale enterprises account for more than 90% of the total drug wholesale market; the annual sales of the top 100 drug retail enterprises account for more than 40% of the total drug retail market; the drug retail chain rate reaches more than 50% December 27 notice of the State Council on printing and distributing the 13th five year plan for national informatization The goal is that by 2018, information technology will promote the convenience of medical and health services, and the telemedicine service system will be basically formed; by 2020, new health information services based on perceptual technology and products will be gradually popularized, and informatization will play a significant role in realizing the basic medical and health services for all December 25 the 25th meeting of the Standing Committee of the 12th National People's Congress voted to adopt the environmental protection tax law of the people's Republic of China 2018 From January 1, 2015, enterprises began to collect environmental protection tax: pay more tax if they discharge more pollutants, and enjoy tax relief if they discharge less pollutants Through the construction of a green tax system to promote the adjustment of economic structure and the transformation of development mode, an effective constraint and incentive mechanism is formed to force enterprises to reduce emissions On December 25, the 25th meeting of the Standing Committee of the 12th National People's Congress deliberated and passed the law of the people's Republic of China on Chinese medicine, which was formally implemented on July 1, 2017; the support for traditional Chinese medicine was fixed in the form of law On December 23, the drug review center of the State Food and Drug Administration issued the notice on soliciting public opinions on the registration template of production process information of listed drugs, and released the registration template of production process information of traditional Chinese medicine, chemical drugs and biological products (Draft for comments) On December 21, the general office of the General Administration of the people's Republic of China publicly solicited opinions on guiding principles such as on-site verification of quality and efficacy conformity assessment of generic drugs, the 16th draft related to conformity assessment issued in 2016 On December 20, Sichuan health and Family Planning Commission printed and distributed the implementation plan for promoting the reform of medical service price in Sichuan Province, the measures for canceling the compensation for drug addition in urban public hospitals in Sichuan Province, and the adjustment plan for canceling the compensation for drug addition in public hospitals in Sichuan Province 2016 Since December 20, 2004, public hospitals in all cities of Sichuan Province have implemented the reform of canceling the drug addition (except for Chinese herbal pieces) and implementing zero margin sales of drugs In principle, 70% of the reasonable income from the reduction of drug addition will be compensated by adjusting the price of medical service and being included in the reimbursement of medical insurance fund according to the regulations, 20% will be compensated by financial investment, the increased financial investment will be included in the budget management, and 10% will be solved by strengthening the management of the hospital and reducing the operation cost On December 16, the State Food and Drug Administration issued the guiding principles for on site inspection of drug quality management specifications, which specified and explained in detail the inspection defect items and judgment results of GSP On December 16, Qinghai provincial government issued the opinions on the implementation of "two ticket system" in the procurement of public medical institutions in Qinghai Province The public medical institutions in Qinghai province implemented "two ticket system", and the primary medical institutions were allowed to issue another purchase and sale invoice On December 15, CFDA website announced the measures for the administration of batch issuance of biological products (Revised Draft) As the main body of batch issuance and declaration, biological products enterprises shall perform their legal responsibilities and obligations in batch issuance activities according to law, and be responsible for the authenticity, integrity and standardization of batch issuance and declaration materials and samples On December 13, Heilongjiang health and Family Planning Commission issued the notice on comprehensively consolidating and expanding the comprehensive reform of county-level public hospitals, in which all kinds of public hospitals at all levels in 63 counties (cities) of the province participated in the reform of public hospitals, regardless of the host body, subordinate relationship, hospital level, guarantee channel, etc., and the procurement was carried out under the two vote system On December 8, the official website of the health and Family Planning Commission issued the notice of the general office of the national health and Family Planning Commission on the implementation of the clinical pathway of diseases, which published 1010 clinical pathways on the website of the Chinese Medical Association, and the market of auxiliary drugs was in a hurry On December 8, the State Council issued the decision on the cancellation of a number of occupational qualification licenses and recognition items, including Chinese herbal medicine growers and solid preparation workers, which cancelled 114 occupational qualification licenses and recognition items On December 8, Anhui health and Family Planning Commission issued the notice on printing and distributing the implementation measures for the adjustment of reference price of medical insurance payment of basic medical insurance drugs in Anhui Province, which made a clear notice on the adjustment scope and method of medical insurance payment price in Anhui Province On December 6, the white paper of Chinese medicine was released, which was the first white paper on the development of Chinese Medicine issued by the Chinese government On December 1, the general office of the General Administration of the people's Republic of China (hereinafter referred to as the general office of the General Administration of the people's Republic of China (hereinafter referred to as the general office of the General Administration of the people's Republic of China (hereinafter referred to as the General Office of the General Administration of the people's Republic of China) publicly solicited the opinions of the "drug clinical trial quality management specification (Revised Draft)", and revised the "drug clinical trial quality management specification" ( On November 30, the notice of Beijing human resources and Social Security Bureau on issues related to playing the regulatory role of medical insurance to promote the construction of hierarchical diagnosis and treatment system in this city was issued on December 1 Community medicine and medical insurance drug catalog of large hospitals in Beijing were combined into one Community and other basic medical institutions should timely prepare relevant drugs according to the needs of patients On November 29, the general office of the General Administration of the people's Republic of China publicly solicited opinions on the general considerations for the evaluation of modified drugs (ordinary oral solid preparations) in the conformity evaluation of quality and efficacy of generic drugs, which were applicable to the evaluation of the modified drugs of ordinary oral solid preparations in the conformity evaluation of quality and efficacy of generic drugs without changing the way of administration On November 29, the general office of the General Administration of the people's Republic of China publicly asked for guidance on the classification of generic drugs for conformity assessment of quality and efficacy, divided the first batch of varieties for conformity assessment into six categories, and made specific requirements for different categories On November 29, the draft of "guidance on further standardizing the quality and efficacy of generic drugs for consistency evaluation of reference preparation selection and other related matters" issued by the General Administration regulated and guided the selection and determination of reference preparation and the access of reference preparation On November 28, the notice of Henan Provincial Department of human resources and social security on adjusting the catalogue of drugs for basic medical insurance, work injury insurance and maternity insurance (2010 version) added 131 varieties or dosage forms such as roxithromycin ambroxol oral regular release dosage form, and the payment category was class B On November 25, Zhejiang provincial health and Family Planning Commission, Provincial Department of Finance and provincial human resources and social security released the implementation opinions on comprehensively launching the pilot of new mechanism of drug procurement for public medical institutions 1 The new mechanism of drug procurement for public medical institutions was officially launched to the pilot cities of the Province, and the status of public hospitals as the main body of drug procurement and price negotiation was once again clear 2 For non-medical insurance drugs, the price increase part of the hospital will be turned over to the financial department of the same level, and will be rewarded to the medical institutions after assessment On November 24, opinions on the implementation of "two vote system" in drug procurement of public medical institutions in Sichuan Province (Draft for comments) comprehensively implemented the two vote system in public medical institutions in Sichuan Province (except grass-roots medical institutions in ethnic minority areas and other regions) from December 31, 2016 On November 23, the notice of the national development and Reform Commission on printing and distributing the plan for the construction of the national health insurance project announced to focus on strengthening the construction of public health, grass-roots medical care, maternal and child health services, diagnosis and treatment of difficult and severe cases, inheritance and innovation of traditional Chinese medicine and population health informatization, and the central investment will increase to the grass-roots, poverty-stricken areas and public health fields On November 21, the general office of the State Council issued the notice on printing and distributing the implementation plan of pollutant emission control license system, which will realize the "one license" management of systematization, scientization, legalization, refinement and informatization, and the environmental protection will force the pharmaceutical enterprises to stop production On November 17, Hebei Provincial air office issued "air pollution prevention and control No.2 dispatching order" involving six cities, Shijiazhuang, Baoding, Cangzhou, Hengshui, Dingzhou and Xinji The notice focuses on the supervision of chemical and pharmaceutical enterprises in Gaocheng and Luancheng, Shijiazhuang On November 15, Tianjin Health and Family Planning Commission issued the notice of Interim Provisions on regional registration of doctors in Tianjin Within the scope of Tianjin, doctors who have registered practice institutions can choose to "start work" in other places without any formalities On November 15, the catalogue of basic medical insurance drugs in urban and rural areas of Hunan Province was formally integrated On November 14, Fujian Provincial Health and Family Planning Commission Hospital Management Bureau "notice on the determination of basic infusion standards in provincial public hospitals" clearly requires hospitals to select and purchase according to the results of the first and second batch of basic infusion price limit network hanging, hospitals and drug manufacturers directly settle accounts, and strictly implement the "one vote system" On November 12, Fujian Medical Insurance Office issued the notice on doing a good job in the code management of medical insurance doctors in the province, which requires the medical insurance agencies of cities and districts in the province to complete the code collection, summary and audit of medical insurance doctors in the region before and after December 31 On November 9, Tianjin Health and Family Planning Commission issued the notice on standardizing the management of intravenous antibiotics infusion in outpatient department, and by the end of 2016, the infusion of antibiotics in outpatient department (excluding Pediatrics) will be stopped; for pediatrics, it is necessary to strictly control the relevant diagnosis and treatment specifications, accurately grasp the indications of intravenous antibiotics infusion, and put an end to unreasonable drugs