Administrative Measures for the List of National Essential Drugs (Interim)

国家基本药物目录管理办法（暂行）

 

Promulgating Institution: Ministry of Health; National Development and Reform Commission;Ministry of Industry and Information; Ministry of Supervision; Ministry of Finance; Ministry of Human Resources and Social Security; Ministry of Commerce; State Food and Drug Administration; State Administration of Traditional Chinese Medicine

Document Number: Wei Yao Zheng Fa [2009] No. 79

Promulgating Date: 08/18/2009

Effective Date: 08/18/2009

 

颁布机关: 卫生部; 国家发展和改革委员会; 工业和信息化部; 监察部; 财政部; 人力资源和社会保障部; 商务部; 国家食品药品监督管理局; 国家中医药管理局

文      号: 卫药政发[2009]79号

颁布时间: 08/18/2009

实施时间: 08/18/2009

These Measures are formulated with a view to implementing the Opinions of the CPC Central Committee and the State Council on Deepening the Reform of the Medical and Health Care System and the Notice of the State Council on Printing and Distributing the Implementation Plan for Recent Priorities of the Reform of the Medical and Health Care System (2009-2011) and establishing a management mechanism for selecting drugs for and adjusting the List of National Essential Drugs.

    为落实《中共中央国务院关于深化医药卫生体制改革的意见》和《国务院关于印发医药卫生体制改革近期重点实施方案（2009-2011年）的通知》精神，建立国家基本药物目录遴选调整管理机制，制定本办法。

  Article 1    Essential drugs shall refer to drugs of proper dosage forms and with reasonable prices and reliable supply, which satisfy basic medical and health care needs and are equally available to the public. All grassroots medical and health care institutions organized by governments shall be supplied with and shall use essential drugs. Other types of medical institutions shall also use essential drugs as required.

       第一条  基本药物是适应基本医疗卫生需求,剂型适宜,价格合理,能够保障供应,公众可公平获得的药品。政府举办的基层医疗卫生机构全部配备和使用基本药物,其他各类医疗机构也都必须按规定使用基本药物。

  Article 2   Drugs included in the List of National Essential Drugs shall include chemical drugs, biological products and Chinese patent medicines. Chemical drugs and biological products shall be classified mainly by clinical pharmacology, while Chinese patent medicines shall be classified mainly by function.

       第二条  国家基本药物目录中的药品包括化学药品、生物制品、中成药。化学药品和生物制品主要依据临床药理学分类,中成药主要依据功能分类。

  Article 3   The National Essential Drug Committee shall be responsible for coordinating the resolution of relevant policy issues in each step of formulating and implementing the national essential drug system, determining the framework of the national essential drug system, as well as the principles, scope, procedures and work plan of selecting drugs for and adjusting the List of National Essential Drugs, and reviewing the List of National Essential Drugs. Relevant departments shall properly select and adjust national essential drugs according to their respective duties and responsibilities. The said Committee shall consist of the Ministry of Health (MOH), the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Supervision, the Ministry of Finance, the Ministry of Human Resources and Social Security, the Ministry of Commerce, the State Food and Drug Administration (SFDA) and the State Administration of Traditional Chinese Medicine. The office of the Committee shall be set within the office site of Ministry of Health, and the office shall be responsible for the daily work of the said Committee.

       第三条  国家基本药物工作委员会负责协调解决制定和实施国家基本药物制度过程中各个环节的相关政策问题,确定国家基本药物制度框架,确定国家基本药物目录遴选和调整的原则、范围、程序和工作方案,审核国家基本药物目录,各有关部门在职责范围内做好国家基本药物遴选调整工作。委员会由卫生部、国家发展和改革委员会、工业和信息化部、监察部、财政部、人力资源和社会保障部、商务部、国家食品药品监督管理局、国家中医药管理局组成。办公室设在卫生部,承担国家基本药物工作委员会的日常工作。

  Article 4   Selection of national essential drugs shall adhere to the following principles: that the drugs shall be necessary for disease prevention and treatment, that the drugs shall be safe and effective, convenient to use and reasonably priced, that the drugs shall be fundamental for people's livelihood, the prime choices in clinic treatment and available to grassroots institutions, and that equal emphasis shall be placed on both Chinese and Western medicines. Types (dosage forms) and quantity of national essential drugs shall be reasonably determined in light of the medication characteristics in China and with reference to international experience. 

Formulation of the List of National Essential Drugs shall be connected with the basic public health care service system, the basic medical service system and the basic medical security system.

       第四条  国家基本药物遴选应当按照防治必需、安全有效、价格合理、使用方便、中西药并重、基本保障、临床首选和基层能够配备的原则,结合我国用药特点,参照国际经验,合理确定品种(剂型)和数量。

    国家基本药物目录的制定应当与基本公共卫生服务体系、基本医疗服务体系、基本医疗保障体系相衔接。

  Article 5   Chemical drugs, biological products and Chinese patent medicines included in the List of National Essential Drugs shall be those recorded in the Pharmacopoeia of the People's Republic of China, and shall comply with the drug standards promulgated by the MOH and the SFDA. Except for emergency drugs and rescue drugs, drugs under exclusive production shall be subject to separate argument before being included in the List of National Essential Drugs. 

With respect to chemical drugs and biological products that adopt generic names in Chinese and international non-patented drug names in English, dosage forms shall be specified separately for any chemical composition expressed in the said names; Chinese patent medicines shall adopt generic names.

       第五条  国家基本药物目录中的化学药品、生物制品、中成药,应当是《中华人民共和国药典》收载的,卫生部、国家食品药品监督管理局颁布药品标准的品种。除急救、抢救用药外,独家生产品种纳入国家基本药物目录应当经过单独论证。

    化学药品和生物制品名称采用中文通用名称和英文国际非专利药名中表达的化学成分的部分,剂型单列;中成药采用药品通用名称。

  Article 6   The following drugs are not eligible for selection into the List of National Essential Drugs:

(1) drugs containing ingredients of national endangered species of wild fauna and flora;

(2) drugs that are mainly used for nourishment and health protection, and are prone to be abused;

(3) drugs that are not prime choices in clinical treatment;

(4) drugs whose production, sale or use is expressly suspended by State food and drug administrations due to serious adverse reactions;

(5) drugs in violation of State laws, regulations or ethics; and

(6) drugs falling under other circumstances specified by the National Essential Drug Committee.

       第六条  下列药品不纳入国家基本药物目录遴选范围:

    (一)含有国家濒危野生动植物药材的;

    (二)主要用于滋补保健作用,易滥用的;

    (三)非临床治疗首选的;

    (四)因严重不良反应,国家食品药品监督管理部门明确规定暂停生产、销售或使用的;

    (五)违背国家法律、法规,或不符合伦理要求的;

    (六)国家基本药物工作委员会规定的其他情况。

  Article 7   According to the principles determined by the National Essential Drug Committee, the MOH shall be responsible for establishing a tank of experts of national essential drugs, and report the same to the National Essential Drug Committee for examination and verification. The export tank shall mainly consist of experts in medicine, pharmacy, pharmaco economics, medical insurance management, health management and price management who shall be responsible for the consulting and assessment of national essential drugs.

       第七条  按照国家基本药物工作委员会确定的原则,卫生部负责组织建立国家基本药物专家库,报国家基本药物工作委员会审核。专家库主要由医学、药学、药物经济学、医疗保险管理、卫生管理和价格管理等方面专家组成,负责国家基本药物的咨询和评审工作。

  Article 8   The MOH shall, in conjunction with relevant departments, draft the work plan and specific principles for selection of drugs for the List of National Essential Drugs, and shall organize the implementation thereof upon review by the National Essential Drug Committee. Procedures for formulating the List of National Essential Drugs are as follows:

(1) randomly select experts from the expert tank of national essential drugs to form a group of experts to provide consulting regarding the List and another group of experts for assessing the List. The consulting experts shall not participate in the assessment of the List, and vice versa;

(2) the group of consulting experts shall conduct technical evaluation of the drugs eligible for selection based on evidence-based medicine and pharmaco economics, present selection opinions and form the list of candidate drugs;

(3) the group of assessment experts shall review and vote on the list of candidate drugs and form a draft of the List;

(4) solicit opinions on the draft List from relevant departments, and form a draft for examination and approval after amendment and improvement based on the opinions;

(5) the draft for examination and approval shall be submitted to the National Essential Drug Committee for review, after which the MOH shall be authorized to release the finalized List.

       第八条  卫生部会同有关部门起草国家基本药物目录遴选工作方案和具体的遴选原则,经国家基本药物工作委员会审核后组织实施。制定国家基本药物目录的程序:

    (一)从国家基本药物专家库中,随机抽取专家成立目录咨询专家组和目录评审专家组,咨询专家不参加目录评审工作,评审专家不参加目录制订的咨询工作;

    (二)咨询专家组根据循证医学、药物经济学对纳入遴选范围的药品进行技术评价,提出遴选意见,形成备选目录;

    (三)评审专家组对备选目录进行审核投票,形成目录初稿;

    (四)将目录初稿征求有关部门意见,修改完善后形成送审稿;

    (五)送审稿经国家基本药物工作委员会审核后,授权卫生部发布。

  Article 9   The List of National Essential Drugs shall be managed dynamically based on a relevantly stable quantity, and be adjusted once every three (3) years in principle. Where necessary, the List of National Essential Drugs may be adjusted as appropriate upon review and approval by the National Essential Drug Committee. The type and quantity to be adjusted shall be determined based on the following factors:

(1) changes in the basic medical and health care needs and the basic medical security level in China;

(2) changes in the disease spectrum in China;

(3) appraisal of adverse drug reaction monitoring;

(4) monitoring and assessment of the application of national essential drugs;

(5) appraisal of released drugs from the view of evidence-based medicine and pharmaco economics; and

(6) other circumstances stipulated by the National Essential Drug Committee.

       第九条  国家基本药物目录在保持数量相对稳定的基础上,实行动态管理,原则上3年调整一次。必要时,经国家基本药物工作委员会审核同意,可适时组织调整。调整的品种和数量应当根据以下因素确定:

    (一)我国基本医疗卫生需求和基本医疗保障水平变化;

    (二)我国疾病谱变化;

    (三)药品不良反应监测评价;

    (四)国家基本药物应用情况监测和评估;

    (五)已上市药品循证医学、药物经济学评价;

    (六)国家基本药物工作委员会规定的其他情况。

  Article 10   Under any of the following circumstances, a drug shall be withdrawn from the List of National Essential Drugs:

(1) where the relevant drug standard has been cancelled; 

(2) where the relevant State food and drug administration cancels the certificate of drug approval of the drug;

(3) where the drug causes serious adverse reaction;

(4) where based on appraisal in terms of pharmaco economics, the drug may be replaced by a drug with a better risk-benefit ratio or more cost-effective drug; or

(5) where there are other circumstances under which a drug shall be withdrawn as considered by the National Essential Drug Committee.

       第十条  属于下列情形之一的品种,应当从国家基本药物目录中调出:

    (一)药品标准被取消的;

    (二)国家食品药品监督管理部门撤销其药品批准证明文件的;

    (三)发生严重不良反应的;

    (四)根据药物经济学评价,可被风险效益比或成本效益比更优的品种所替代的;

    (五)国家基本药物工作委员会认为应当调出的其他情形。

  Article 11   Adjustment of the List of National Essential Drugs shall be subject to the provisions in Article 4, Article 5, Article 6 and Article 9 herein, and be conducted according to the procedures in Article 8 herein. Drugs under the circumstances in Article 10 shall be withdrawn from the List upon review by the National Essential Drug Committee.

       第十一条  国家基本药物目录的调整应当遵循本办法第四条、第五条、第六条、第九条的规定,并按照本办法第八条规定的程序进行。属于第十条规定情形的品种,经国家基本药物工作委员会审核,调出目录。

  Article 12   Selection of drugs for and adjustment of the List of National Essential Drugs shall be scientific, fair, open and transparent. Appraisal standards and working mechanisms shall be established and improved for evidence-based medicine and pharmacon economics, and the List shall be formulated in a scientific and reasonable way. Relevant authorities shall solicit opinions and suggestions from all sectors of the society and accept social supervision.

       第十二条  国家基本药物目录遴选调整应当坚持科学、公正、公开、透明。建立健全循证医学、药物经济学评价标准和工作机制,科学合理地制定目录。广泛听取社会各界的意见和建议,接受社会监督。

  Article 13   Essential drug administration for processed slices of Chinese crude medicines shall, for the time being, be subject to the policies of relevant departments of the State Council on pricing, procurement, distribution, application and basic medical insurance payment concerning processed slices of Chinese crude medicines.

       第十三条  中药饮片的基本药物管理暂按国务院有关部门关于中药饮片定价、采购、配送、使用和基本医疗保险给付等政策规定执行。

  Article 14   Scientific research institutions, pharmaceutical enterprises and social organizations are encouraged to engage in the appraisal of national essential drugs from the view of evidence-based medicine and pharmaco economics.

       第十四条  鼓励科研机构、医药企业、社会团体等开展国家基本药物循证医学、药物经济学评价工作。

  Article 15   These Measures shall be interpreted by the MOH.

       第十五条  本办法由卫生部负责解释。

  Article 16    These Measures shall come into effect on the date of promulgation.

       第十六条  本办法自发布之日起施行。