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| Opinions of the General Office of the State Council on Improving the National Essential Drugs System | | 国务院办公厅关于完善国家基本药物制度的意见 |
| (No. 88 [2018] of the General Office of the State Council) | | （国办发〔2018〕88号） |
| The people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government; all ministries and commissions of the State Council; and all institutions directly under the State Council: | | 各省、自治区、直辖市人民政府，国务院各部委、各直属机构： |
| The national essential drugs system is the foundation of the drug supply guarantee system and an important part of basic public services in the health care field. Since the latest round of health care reform, the establishment and implementation of the national essential drugs system has played a significant role in improving the drug supply guarantee system, ensuring the essential drugs for the general public, and reducing the burden on patients as a result of drug use. At the same time, there are problems such as failure to meet all the clinical needs for essential drugs, lack of a use stimulation mechanism, gap between the quality and therapeutic effect of generic drugs and original ones, and unsound guarantee and supply mechanism. For the purposes of implementing the arrangements and requirements of the National Health Conference, the Outline of the "Healthy China 2030" Plan and deepening the reform of the drugs and health care system and further improving the national essential drugs system, with the approval of the State Council, the following opinions are hereby offered. | | 国家基本药物制度是药品供应保障体系的基础，是医疗卫生领域基本公共服务的重要内容。新一轮医改以来，国家基本药物制度的建立和实施，对健全药品供应保障体系、保障群众基本用药、减轻患者用药负担发挥了重要作用。同时，也还存在不完全适应临床基本用药需求、缺乏使用激励机制、仿制品种与原研品种质量疗效存在差距、保障供应机制不健全等问题。为贯彻落实全国卫生与健康大会、《“健康中国2030”规划纲要》和深化医药卫生体制改革的部署要求，进一步完善国家基本药物制度，经国务院同意，现提出以下意见。 |
| I. General requirements | | 一、总体要求 |
| The spirit of the 19th CPC National Congress and the Second and Third Plenary Sessions of the 19th CPC Central Committee shall be implemented comprehensively, Xi Jinping Thought on Socialism with Chinese Characteristics in a New Era shall be regarded as the guidance, people's health shall be adhered to as the center, the designated functions of essential drugs such as "highlighted essentials, necessity for prevention and control, supply guarantee, priority of use, quality assurance, and burden reduction shall be enhanced, policies shall be improved with respect to the links of essential drugs including election, production, circulation, use, payment and monitoring, the building of the drug supply guarantee system shall be comprehensively driven, particular efforts shall be made to ensure the safety and effectiveness of drugs, reasonableness of prices, and sufficiency of supply, and the problem of "expensive medical care" shall be alleviated. The linkage between higher-level and lower-level medical institutions with respect to drug use shall be promoted, contribution shall be made to the building of a hierarchical medical treatment system, and the transformation, upgrading and supply-side structural reform of the pharmaceutical industry shall be promoted. | | 全面贯彻党的十九大和十九届二中、三中全会精神，以习近平新时代中国特色社会主义思想为指导，坚持以人民健康为中心，强化基本药物“突出基本、防治必需、保障供应、优先使用、保证质量、降低负担”的功能定位，从基本药物的遴选、生产、流通、使用、支付、监测等环节完善政策，全面带动药品供应保障体系建设，着力保障药品安全有效、价格合理、供应充分，缓解“看病贵”问题。促进上下级医疗机构用药衔接，助力分级诊疗制度建设，推动医药产业转型升级和供给侧结构性改革。 |
| II. Dynamically adjusting and optimizing the list | | 二、动态调整优化目录 |
| 1. Satisfying the needs for essential medical care. Guided by the satisfaction of the needs for essential drugs for disease prevention and treatment, according to the characteristics of disease spectrum and drug use in China, taking into full consideration the basic national conditions and guarantee capabilities for the time being, in adherence to the principles of scientificity, openness, fairness and impartiality, with medical treatment norms, guides to clinical treatment and expert consensus as the basis, with an equal focus on both traditional Chinese and Western drugs, appropriate numbers of essential drugs shall be elected to meet common diseases, chronic diseases, emergency rescue, and other main clinical needs, taking into account the drug needs of children and other special populations as well as prevention and treatment with respect to public health. Evidence-based decision-making shall be enhanced, and the clinical value of drugs shall be highlighted; and dosage form specifications shall be regulated, drugs that may be taken orally may not be administered by intramuscular injection, and drugs that may be administered by intramuscular injection shall not be done by infusion. The development of traditional Chinese medicine shall be supported, and the research, development and innovation in the pharmaceutical industry shall be encouraged. | | （一）适应基本医疗卫生需求。以满足疾病防治基本用药需求为导向，根据我国疾病谱和用药特点，充分考虑现阶段基本国情和保障能力，坚持科学、公开、公平、公正的原则，以诊疗规范、临床诊疗指南和专家共识为依据，中西药并重，遴选适当数量的基本药物品种，满足常见病、慢性病、应急抢救等主要临床需求，兼顾儿童等特殊人群和公共卫生防治用药需求。强化循证决策，突出药品临床价值；规范剂型规格，能口服不肌注，能肌注不输液。支持中医药事业发展，鼓励医药行业研发创新。 |
| 2. Improving the list adjustment and management mechanism. The election and adjustment procedures for the essential drugs list shall be optimized, regular assessment and dynamic adjustment of the essential drugs list shall be conducted by taking into account the clinical drug application practices, changes in drug standards, the information on newly marketed drugs and other factors, and the adjustment cycle shall not exceed three years in principle. For drugs whose marketing is newly approved, of which the therapeutic effect significantly improves compared with marketed drugs, and the price of which is reasonable, the adding procedure may be initiated in due course. The emphasis on both adding and removal shall be adhered to, and priority shall be given to adding drugs with determinate evidence of effectiveness and safety and a significant benefit-cost ratio; and the focus shall be on removing a drug which results in relatively many serious adverse reactions, rendering it, as assessed, unsuitable as an essential drug, or for which the substitutions have a higher risk-benefit ratio or benefit-cost ratio. In principle, no region may additionally add drugs, and minority regions may additionally add a small number of ethnic drugs. | | （二）完善目录调整管理机制。优化基本药物目录遴选调整程序，综合药品临床应用实践、药品标准变化、药品新上市情况等因素，对基本药物目录定期评估、动态调整，调整周期原则上不超过3年。对新审批上市、疗效较已上市药品有显著改善且价格合理的药品，可适时启动调入程序。坚持调入和调出并重，优先调入有效性和安全性证据明确、成本效益比显著的药品品种；重点调出已退市的，发生严重不良反应较多、经评估不宜再作为基本药物的，以及有风险效益比或成本效益比更优的品种替代的药品。原则上各地不增补药品，少数民族地区可增补少量民族药。 |
III. Effectively guaranteeing production and supply
．．．．．． | | 三、切实保障生产供应
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