The notice issued by the national basic drugs directory management measures 
 
 
The 2015-04-14 national health and population and family planning commission of the People's Republic of China 

Countries who medicine ZhengFa [2015] no. 52 

Provinces, autonomous regions and municipalities directly under the central government and xinjiang production and construction corps and health (health) state family planning commission, national development and reform commission, price bureau, the competent department of industry and information technology, financial department (bureau), human resources, social security department (bureau), the department (bureau) of commerce, food and drug supervision bureau, bureau of traditional Chinese medicine:
 
    To consolidate the basic drug system, establish and improve the national list of essential medicines to adjust the management mechanism, the national health and family planning commission, the national development and reform commission, ministry of industry and information technology, ministry of finance, human resources and social security ministry, the ministry of commerce, food and drug supervision bureau, bureau of traditional Chinese medicine, general logistics department of the ministry of health on the national list of essential medicines management measures (provisional) (who medicine ZhengFa [2009] no. 79) revised, formed the catalogue of national basic drugs management method "(available from the national health and family planning commission website" paper "download). Hereby printed and distributed to you, please comply with them. 

The national health and family planning commission of the national development and reform commission
 
The ministry of industry and information technology ministry of finance
 
Human resources social security ministry of commerce
 
The food and drug supervision administration of the state bureau of traditional Chinese medicine
 
The general logistics department of the ministry of health
 
On February 13, 2015 

Measures for the administration of national basic drugs directory 

    According to the central committee of the communist party of the opinions of the state council on deepening the reform of medical health system "spirit, to consolidate the basic drug system, establish and improve the national list of essential medicines selection to adjust the management mechanism, these measures are formulated.
 
    The first essential medicines is to meet the needs of basic medical and health care, dosage form is appropriate, the price is reasonable, can guarantee supply, the public can equitable access to medicines. Government at the grassroots medical institutions all equipped with and using the basic medicine, other kinds of medical institutions also must be in accordance with the use of essential medicines.
 
    Article 2 the state basic drugs directory include chemical, biological products, proprietary Chinese medicine and Chinese medicine yinpian. Main chemical medicines and biological products according to the classification of clinical pharmacology, proprietary Chinese medicine main basis function classification.
 
    Article 3 the state basic drugs working committee responsible for coordinating to solve the formulation and implementation of each link in the process of national system for basic drugs related policy issues, determine the frame of national system for basic drugs, establish national list of essential medicines selection and adjustment principle, scope, procedures and work plan, review the national list of essential medicines, the relevant departments within the scope of responsibilities to do a good job of selecting national essential drugs to adjust. The committee by the national health and family planning commission, the national development and reform commission, ministry of industry and information technology, ministry of finance, human resources, social security, the ministry of commerce, the state food and drug supervision bureau, the state bureau of traditional Chinese medicine, the general logistics department of the ministry of health. Office is located in the national health and family planning commission, assume the routine of the national essential drugs work committee.
 
    Article 4 the state basic drugs selection shall, in accordance with the prevention and control required, safe and effective, reasonable price, easy to use, paying equal attention to Chinese and western medicine, basic guarantee, clinical choice and grass-roots can equipped with the principle of combining with the characteristics of Chinese medicine, with reference to international experience, reasonable varieties (form) and quantity.
 
    National list of essential medicines should be made to the basic public health service system and basic medical and health service system, basic medical insurance system.
 
    Article 5 the state basic drugs directory of Chinese medicines, chemical medicine, biological products, and should be the law of the People's Republic of China pharmacopoeia records, published by the state food and drug regulator, the ministry of health pharmaceutical standards. In addition to the first aid, rescue medication, exclusive products into the state's basic drugs directory should be after a single argument.
 
    Chemical medicines and biological products name using generic names in Chinese and English international express the chemical composition of part of the generic medicines, dosage form single; Proprietary Chinese medicine USES drug generic names.
 
    Article 6 the following drugs are not included in the scope of national basic drugs directory search:
 
    (a) contains the national endangered species of wild fauna and flora species;
 
    (2) is mainly used in health tonic, easy to abuse;
 
    (3) the clinical treatment of the preferred;
 
    (4) because of serious adverse events, the state food and drug regulators make clear a regulation to suspend production, the sale or use;
 
    (5) violation of state laws and regulations, or do not conform to the requirement of ethics;
 
    (6) other conditions stipulated by national essential drugs work committee.
 
    Article 7, according to the principle of state basic drugs working committee, the national health and family planning commission shall be responsible for establishment of national essential medicine expert database, submitted to the national essential drugs work committee review. Expert database is mainly composed of medicine and pharmacy, pharmacoeconomics, drug supervision, pharmaceutical production supply management, medical insurance, health management and price management experts, be responsible for the national essential drugs advisory and review.
 
    Article 8 the state health and family planning commission jointly with relevant departments to draft the national list of essential medicines selection work plan and specific selection principle, by the national basic drugs after working committee review. Establishes the procedures by which national basic drugs directory:
 
    (a) from the national essential drugs in the expert database, randomly established expert advisory group of experts and directory review panel, consultants do not participate in the directory review work, evaluation experts do not participate in the directory of consulting work;
 
    (2) according to evidence-based medicine, drug economics advisory group of experts to evaluate technology included in the selection range of drugs, selection opinions, form the alternative directory;
 
    (3) the review panel to alternative directory review vote, form the first draft of the directory;
 
    (4) the directory first draft solicit opinions from the relevant departments, after the amended form SongShenGao;
 
    (5) SongShenGao after national essential drugs working committee review, authorized the national health and family planning commission.
 
    Article 9 the state basic drugs directory on the basis of maintain a relatively stable, implements the dynamic management, 3 years in principle to adjust one more time. When necessary, subject to consent by the national essential drugs working committee review, can be adjusted timely organization. Adjust the variety and quantity shall be determined according to the following factors:
 
    (a) basic medical and health care demand in China and the basic medical insurance;
 
    (2) disease in our country;
 
    (3) the adverse drug reaction monitoring and evaluation;
 
    (4) the national essential drugs application monitoring and assessment;
 
    (5) drugs already on the market of evidence-based medicine, drug economics evaluation;
 
    (6) other conditions stipulated by national essential drugs work committee.
 
    Article 10 the belongs to the varieties of the following circumstances, shall be out from the national list of essential medicines:
 
    (a) drug standards be cancelled;
 
    (2) the state food and drug regulatory authorities revoke the drug approval documents;
 
    (3) serious adverse reaction, the assessment should not be used as a national essential drug;
 
    (4) according to the pharmacoeconomics evaluation, can be risk benefit ratio and cost effective than better varieties replaced;
 
    (5) the national essential drugs work committee deems the bring up other circumstances.
 
    Article 11 the state basic drugs directory adjustment shall comply with article 4 of this regulation, article 5, article 6, article 9 of the regulations, and in accordance with the procedures stipulated in article 8 hereof. Belongs to the variety of situations stipulated in article 10, the national essential drugs work committee review, bring up a directory.
 
    Article 12 the national list of essential medicines selection adjustment shall adhere to the scientific, fair, open and transparent. Establish and improve the evidence-based medicine, drug economics evaluation standard and working mechanism, set up a scientific and reasonable directory. Widely listen to opinions and Suggestions from all sectors of society, accept social supervision.
 
    Article 13 Chinese medicine yinpian, the basic drug management temporarily according to the relevant departments of the state council about Chinese medicine yinpian pricing, purchasing, distribution, use, and pay of insurance of primary medical treatment such as policy provisions.
 
    Article 14 the encourages scientific research institutions, pharmaceutical enterprises, social organizations, etc. To carry out the national essential drugs of evidence-based medicine, drug economics evaluation.
 
    Article 15 the state health and family planning commission shall be responsible for the interpretation of these procedures.
 
    Article 16 these regulations shall come into force from the date of release.