Announcement on Soliciting Public Opinions on the Measures for the Administration of the National Essential Drug List (Revised Draft)
In order to further consolidate the national essential drug system and establish and improve the selection and adjustment mechanism of the national essential drug list, the Department of Drug Administration of the National Health Commission organized the study and revision of the measures for the Administration of the National essential Drug list (issued in 2015), and formed the revised draft of the measures for the Administration of the National essential Drug list (see annex). Now for the public to solicit opinions.
In order to further consolidate the national essential drug system and establish and improve the selection and adjustment mechanism of the national essential drug list, the Department of Drug Administration of the National Health Commission organized the study and revision of the measures for the Administration of the National essential Drug list (issued in 2015), and formed the revised draft of the measures for the Administration of the National essential Drug list (see annex).
Now for the public to solicit opinions, the public can feedback through the following ways:
1. email: email@example.com.
2. letter: Department of Pharmacy, National Health Commission, No. 38, Beilisi Road, Xicheng District, Beijing 100044. Please indicate on the envelope the words "National Essential Drug Catalogue Management Measures for Comments.
3. fax: 010-68791738. Feedback deadline is December 14, 2021
Department of Pharmacy, National Health Commission
November 15, 2021
Measures for the Administration of the List of Essential Medicines of Annex Countries (Revised Draft)
Article 1 In order to promote the implementation of the healthy China strategy, consolidate and improve the national essential drug system, further standardize and improve the national essential drug list management mechanism, and ensure citizens' basic medical and health services, these measures are formulated in accordance with the the People's Republic of China basic Medical and Health Promotion Law, the the People's Republic of China Drug Administration Law and other legal provisions, the opinions of the General Office of the State Council on improving the National essential Drug system, and the opinions of the General Office of the State Council on further doing a good job in ensuring the supply and price stability of drugs in shortage.
Article 2 The State shall implement a system of essential medicines and select an appropriate number of varieties of essential medicines to meet the needs of essential medicines for disease prevention and treatment.
Article 3 Essential medicines refer to medicines that meet the needs of basic medicines for disease prevention and treatment, adapt to the basic national conditions and guarantee capabilities at the present stage, have suitable dosage forms, reasonable prices, can guarantee supply, and can be obtained fairly.
Article 4 The State shall publish the catalogue of essential medicines, and make dynamic adjustments to the catalogue of essential medicines in accordance with the clinical practice of medicines, changes in drug standards, and the situation of new drugs on the market. The management of the list of essential medicines should be scientific, fair, open, and transparent, extensively listen to opinions and suggestions from all walks of life, and accept social supervision.
Article 5 the selection of essential drugs shall be based on the functional orientation of "highlighting the basic, preventing and controlling the necessity, ensuring the supply, giving priority to the use, ensuring the quality and reducing the burden", and adhere to the principle of attaching equal importance to Chinese and Western medicine and clinical first choice, and reasonably determined with reference to international experience.
Article 6 The National Essential Medicines Working Committee is responsible for coordinating and solving important policy issues in the formulation and implementation of the national essential medicine system, determining the principles, scope, procedures and work plans for the selection and adjustment of the national essential medicine list, and reviewing the national essential medicine list. The National Essential Medicines Working Committee is composed of the National Health Commission, the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the Ministry of Finance, the Ministry of Commerce, the General Administration of Market Supervision, the National Medical Insurance Administration, the State Administration of Traditional Chinese Medicine, the State Food and Drug Administration, The National Disease Control Bureau and the Health Bureau of the Logistics Support Department of the Central Military Commission are composed. The office is located in the National Health Commission and undertakes the daily work of the National Essential Drug Working Committee. Each member unit shall undertake the specific matters of the selection and adjustment of national essential drugs and the implementation of the system within the scope of its duties.
Article 7 National essential drugs include the catalogue of chemical drugs and biological products, the catalogue of traditional Chinese medicine and the catalogue of children's drugs. Chemical drugs and biological products are mainly classified according to clinical pharmacology, traditional Chinese medicine is mainly classified according to function, and children's drugs are mainly classified according to children's special applicable drugs.
Article 8 the drugs included in the national essential drug list shall be those approved by the national drug regulatory department and obtained the drug registration certificate or approval number, as well as the decoction pieces of traditional Chinese medicine prepared according to the national standards. In addition to emergency (rush) rescue drugs, the exclusive production of varieties into the national list of essential drugs should be separately demonstrated. The names of chemicals and biological products shall be the parts of the chemical components expressed in the Chinese generic names and the international non-patent drugs in English, and the dosage forms shall be listed separately; the generic names of Chinese patent medicines shall be used.
Article 9 the following drugs shall not be included in the selection scope of the national essential drug list: (1) those containing national endangered wild animal and plant medicinal materials; those (II) are mainly used for nourishing and health care, easy to abuse, and those included in the national key monitoring and rational drug use list; (III) those whose production, sale or use are clearly suspended by the national drug regulatory department due to serious adverse reactions; (IV) those that violate national laws and regulations, or do not meet ethical requirements; (V) other circumstances specified by the National Working Committee on Essential Medicines.
Article 10 In accordance with the principles of the selection and management of national essential drugs, the National Health Commission is responsible for establishing an expert consultation and demonstration system, organizing the establishment of a national essential drug expert database, and reporting to the National Essential Drug Working Committee for review. The expert database is mainly composed of experts in medicine (including public health), pharmacy (including traditional Chinese medicine), evidence-based medicine, pharmacoeconomics, drug supervision, drug production and supply management, medical insurance management, health management and price management, and is responsible for the consultation and evaluation of national essential drugs.
Article 11 The National Health Commission shall draft a work plan for the selection of the National Essential Drug List in accordance with the law, formulate specific selection rules, solicit opinions from relevant departments and relevant parties in accordance with the law, and be reviewed by the National Essential Drug Working Committee, organize implementation in accordance with procedures and publish it to the public. The procedures for formulating the national essential drug list are as follows: (1) experts are randomly selected from the national essential drug expert database to set up a catalog consultation expert group and a catalog review expert group; the (II) consultation expert group conducts technical evaluation of drugs according to disease prevention and clinical needs, through evidence-based medicine, drug clinical use monitoring, drug economics, etc., and puts forward selection opinions to form alternative catalogs. The (III) review expert group conducts technical demonstration and comprehensive evaluation of alternative catalogs, form the first draft of the catalog; (IV) the first draft of the catalog and send it to the member units of the National Essential Medicines Working Committee for comments, revise and improve the draft of the catalog for review; after the (V) draft is reviewed by the National Essential Medicines Working Committee, it is submitted for approval in accordance with the procedures, and the National Health Commission Released and organized implementation.
Article 12 The national essential drug list shall adhere to regular evaluation and dynamic management, and the adjustment period shall not exceed 3 years in principle. When necessary, with the approval of the National Working Committee on Essential Medicines, adjustments can be organized in due course. The variety and quantity of adjustment shall be determined according to the following factors: (1) changes in the demand for basic medical and health services and the level of basic medical security in China; (II) changes in the spectrum of diseases in China; monitoring and evaluation of adverse reactions of (III) drugs; monitoring and comprehensive clinical evaluation of the use of (IV) drugs; evidence-based medicine and pharmacoeconomic evaluation of (V) listed drugs; and other circumstances stipulated by the National working Committee on essential drugs in (VI).
Article 13 A variety that falls under one of the following circumstances shall be transferred from the national essential drug list: (1) serious adverse reactions, or changes in clinical diagnosis and treatment guidelines and disease prevention and control norms, are no longer suitable for use as national essential drugs after assessment; (II) can be replaced by varieties with better risk-benefit ratio or cost-benefit ratio according to comprehensive clinical evaluation of drugs or pharmacoeconomic evaluation; (III) other circumstances that the National Essential Drug Working Committee believes should be transferred.
Article 14 the selection and adjustment of the list of essential drugs shall follow the provisions of articles 3, 4, 5, 7, 8, 9 and 12 of these measures, and shall be carried out in accordance with the procedures stipulated in Article 11 of these measures. The varieties that fall under the circumstances specified in Article 13 shall be transferred out of the catalogue after expert evaluation and examination by the National Essential Drug Working Committee.
Article 15 The basic drug management of Chinese herbal pieces shall be temporarily implemented in accordance with the policies and regulations of the relevant departments of the State Council on the price, procurement, distribution, use and payment of reimbursement of Chinese herbal pieces. The supply guarantee, equipment and use of drugs in the list of essential drugs shall be implemented in accordance with relevant laws and policies.
Article 16 If it is necessary to identify the catalogue ownership of national essential drug varieties and dosage forms due to renaming, different names and other reasons, the National Health Commission shall identify them in accordance with the procedures.
Article 17 The National Health Commission is responsible for establishing and improving the drug use monitoring and clinical comprehensive evaluation system focusing on essential drugs, formulating monitoring and evaluation management standards and technical guidelines, and organizing the collection and comprehensive analysis of relevant drug clinical use evidence, drug policy information, Provide evidence-based basis and technical support for dynamically optimizing the list of essential drugs and improving the management policy of essential drug allocation and use. Medical and health institutions are encouraged to organize and carry out comprehensive clinical evaluation of drugs focusing on national essential drugs, and strengthen the analysis and application of evaluation results.
Article 18 These Measures shall be interpreted by the National Health Commission.
Article 19 These Measures shall enter into force as of the date of promulgation. The Measures for the Administration of the National Essential Drug List issued by the former National Health and Family Planning Commission on February 13, 2015 shall be abolished immediately.