Led by the national health and Health Commission, another heavy catalog will be published this year!

Notice on printing and distributing the work plan for accelerating the implementation of supply guarantee and use policy of generic drugs (gwsgf [2018] No 53) Health and Health Commission (health and Family Planning Commission), development and Reform Commission, Department of Education (Education Commission), Department of science and Technology (Science and Technology Commission), competent department of industry and information technology, Department of Finance (bureau), market supervision bureau, medical insurance bureau, traditional Chinese Medicine Bureau, drug administration, intellectual property office and high people's Court of all provinces, autonomous regions, municipalities directly under the central government and Xinjiang production and Construction Corps: In April 2018, the general office of the State Council issued the opinions on reforming and improving the supply guarantee and use policy of generic drugs (GBF [2018] No 20) In order to ensure the effectiveness of the decision-making and deployment of the Party Central Committee and the State Council, we have formulated the work plan on accelerating the implementation of the supply guarantee and use policy of generic drugs It is printed and distributed to you Please implement it carefully State Health Commission, State Development and Reform Commission, Ministry of education, Ministry of science and technology, Ministry of industry and information technology, Ministry of finance, General Administration of market supervision, state health insurance bureau, State Administration of traditional Chinese medicine, State Food and drug administration, State Intellectual Property Office, Supreme People's court, December 18, 2018 (form of information disclosure: active disclosure) on accelerating the implementation of supply guarantee and use policy of generic drugs In order to further improve the supply guarantee capacity of generic drugs in China, accelerate the implementation of the opinions of the general office of the State Council on reforming and improving the supply guarantee and use policy of generic drugs (GBF [2018] No 20), and better meet the people's demand for high-quality generic drugs, this work plan is hereby formulated 1、 Make clear the key tasks (1) timely release the catalogue of drugs to be imitated According to the clinical drug demand, before the end of June 2019, the first batch of drug catalogues encouraging imitation will be released to guide the research, development, registration and production of enterprises From 2020, the list of drugs to be imitated will be released by the end of each year (the national health and Health Commission, the State Food and drug administration, and the Ministry of industry and information technology are in charge, and the first is the leading unit, the same below) (2) strengthen the research on generic pharmaceutical technology The supporting technologies that restrict the development of generic pharmaceutical industry (including the research and development of key technologies for drug imitation, the improvement and transformation of preparation process, the research and development of raw and auxiliary materials and packaging materials, etc.) and the drugs and their preparations that are clinically necessary and have not been imitated in China are included in the relevant national science and technology plans to tackle key scientific and technological problems After the introduction of the catalogue of drugs to be imitated, the research on key generic technologies of key chemicals and biological drugs in the catalogue shall be included in the relevant national science and technology plans in a timely manner Research and formulate the 2019-2023 generic pharmaceutical science and technology research plan When the conditions are mature, report to the inter ministerial joint meeting of national science and technology plan management for deliberation (in the charge of the Ministry of science and technology, the national health and Health Commission, the Ministry of finance, the national development and Reform Commission, the State Drug Administration, the Ministry of industry and information technology, and the Ministry of Education) "Major generic drugs" will be listed as the key support direction for strengthening the core competitiveness of manufacturing industry and technological transformation within the central budget, and the action plan for 2018-2020 will be formulated (the national development and Reform Commission, the Ministry of industry and information technology, the national health and Health Commission, the Ministry of science and technology, the Ministry of Finance and the State Food and drug administration are responsible for) (3) improving the protection of pharmaceutical intellectual property rights In accordance with the principle of encouraging the creation of new drugs and the research and development of generic drugs, we will study and improve the intellectual property protection system of drugs that is suitable for China's economic and social development level and industrial development stage Implement the patent quality improvement project, formulate the annual implementation plan for the patent quality improvement project, and cultivate more core intellectual property rights, original intellectual property rights and high-value intellectual property rights of drugs (in the charge of the State Intellectual Property Office, the State Drug Administration, the State Health Commission and the State Administration of traditional Chinese Medicine) We will do a good job in basic research, gradually explore and study the drug patent link system, and reduce the risk of patent infringement of generic drugs Formulate detailed rules for the implementation of the patent challenge system, and clarify the relevant procedures for patent challenge application, acceptance and result publicity (the State Food and drug administration, the State Intellectual Property Office, the state health and Health Commission and the Supreme People's court are respectively responsible for) (IV) accelerating the improvement of the quality of listed drugs Optimize the review and approval process, and give priority to the review and approval of generic drugs included in the catalogue of encouraged generic drugs Strictly review and approve drugs, adhere to the principle of consistent with the quality and efficacy of the original research drugs, accept and review and approve generic drugs, and improve the quality and safety level of drugs We will accelerate the evaluation of the quality and efficacy of generic drugs, and refine and implement policies and measures to encourage enterprises to carry out the evaluation Further release the resources of conformity assessment, and support qualified medical institutions, colleges and universities, scientific research institutions and social inspection and testing institutions to participate in the conformity assessment Effective measures should be taken to improve the enthusiasm of medical institutions and medical personnel in carrying out clinical trials (the State Food and drug administration, the state health and Health Commission, the Ministry of science and technology, and the industry and information technology departments shall be respectively responsible for) (5) promoting the alternative use of generic drugs By the end of 2018, we will fully implement the preparation of drug purchase catalogue according to the common name The products that pass the consistency evaluation shall be preferentially selected for centralized drug procurement (in the charge of the state health insurance bureau, the State Health Commission and the State Drug Administration, and implemented by the local authorities in combination with the actual situation) We will promote the high-quality development of pharmaceutical care, strengthen the supervision of clinical drug use, and promote rational clinical drug use Before the end of June 2019, the administrative measures for the assessment of the rational use of drugs in medical institutions shall be formulated We should fully implement the prescription review system, use information technology to implement dynamic monitoring and abnormal early warning of prescriptions, and timely intervene in unreasonable use of drugs Formulate the action plan for 2019-2023, carry out the comprehensive clinical evaluation of drugs, and focus on the evaluation of treatment effect, adverse reactions, medication plan, pharmacoeconomics and other aspects We should strengthen the construction of pharmacist team, improve the technical level of pharmacists, and strengthen the role of pharmacists in prescription audit and drug allocation (in the charge of the National Health Commission and implemented by the local government in combination with the actual situation) (VI) deepen the reform of the payment mode of medical insurance We will accelerate the reform of payment methods for medical insurance, comprehensively promote the establishment of a multi-component payment method for medical insurance that focuses on payment by disease, and gradually reduce payment by project Encourage the exploration of DRG payment Through the guidance measures of medical insurance drug payment standard, the generic drugs and the original research drugs that pass the consistency evaluation of quality and efficacy will be paid according to the same standard step by step In the areas where the reform of medical insurance payment method is fully implemented and where the payment standard of medical insurance drugs has been formulated, public hospitals are allowed to jointly purchase drugs with quantity and budget on the provincial drug centralized purchase platform (in charge of the National Health Insurance Bureau and the National Health Commission, and implemented by the local government in combination with the actual situation) (VII) strengthen the anti-monopoly law enforcement We will continue to intensify efforts to crack down on monopolistic behaviors in the field of APIs, actively carry out law enforcement activities according to the clues reported and found, and deal with enterprises that monopolize APIs in accordance with the law more seriously and quickly to form an effective deterrent; we will publicly expose typical cases of API monopoly, strengthen publicity, and guide API operators to operate in accordance with the law We should pay close attention to the abuse of intellectual property rights in the field of drugs to eliminate and restrict competition, timely file and investigate suspected monopolies, increase penalties for those that constitute monopolies, and maintain a fair competition market environment (in the charge of the General Administration of market supervision) 2 Strengthen the organization and Implementation (1) establish a cooperative promotion mechanism Under the leadership of the leading group of the State Council to deepen the reform of the medical and health system, the national health and Health Commission is responsible for holding regular work promotion meetings, timely mastering the progress of the implementation of generic drug policies, sorting out the phased work, and negotiating to solve the problems in the work promotion （2） Strengthen work responsibility All relevant departments should attach great importance to promoting the implementation of supply guarantee and use policy of generic drugs, and consolidate the responsibility The Ministry of science and technology should actively promote the inclusion of key pharmaceutical technology research that encourages imitation in the national science and technology plan The national development and Reform Commission should promptly formulate support programs and action plans for "major generic drugs" The State Food and drug administration should speed up the evaluation of the quality and efficacy of generic drugs The state medical insurance bureau should promote the alternative use of generic drugs through the pilot work of centralized drug purchase organized by the state and the reform of payment methods of medical insurance The national health and Health Commission should effectively promote the rational use of drugs in clinical practice and improve the ability of drug supply guarantee All departments and regions should establish a leadership system and work mechanism to promote the implementation of various tasks of generic drugs, clarify the division of responsibilities, decompose tasks at all levels, strengthen accountability, and ensure that all work is carried out in accordance with the timetable and roadmap （3） Strengthen supervision and implementation Establish a mechanism for supervision, inspection, assessment and accountability, and timely organize and carry out special supervision on the implementation of generic drug policies The departments and regions that have completed the task of generic drug reform well shall be praised; the departments and regions that have not completed the task as required shall be notified and ordered to rectify （4） Strengthen publicity and interpretation The national health and Health Commission, together with relevant departments, should vigorously publicize and interpret policies and measures, increase publicity efforts to support and encourage generic drug policies, reasonably guide public opinion and public expectations, and create a good atmosphere for promoting the alternative use of high-quality generic drugs All relevant departments shall closely follow up the progress of the work, summarize the experience in time, and study and solve the problems in the reform We should speed up the promotion of mature reform experience.