2021 Basic Drug List Management Measures Released, National Health Commission's Department of Pharmaceutical Affairs, Public Solicitation of Comments

On November 15, the Pharmaceutical Affairs Department of the National Health Commission issued an announcement on the public consultation on the "National Essential Drug List Management Measures (Revised Draft)"
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The announcement stated that in order to further consolidate the national essential medicine system and establish a sound national essential medicines catalog selection and adjustment mechanism, the Department of Pharmaceutical Affairs of the National Health Commission organized research and revision of the "National Essential Medicines Catalog Management Measures" (issued in 2015), and formed the "National Essential Drugs List" Revision Draft of Catalog Management Measures (see attachment)
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Appendix

Measures for the Administration of the National Essential Drug List

(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 catalog management mechanism, and guarantee basic medical and health services for citizens, in accordance with the Basic Medical Hygiene and Health Promotion Law of the People’s Republic of China, the People’s Republic of China The Republic’s Drug Administration Law and other legal provisions and the “Opinions of the General Office of the State Council on Improving the National Essential Drug System” and “Opinions of the General Office of the State Council on Further Doing a Good Job in Guaranteeing Supply and Stabilizing Prices of Drugs in Shortage” and other documents are deployed to formulate these measures
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Article 2 The State implements an essential medicine system, selects an appropriate number of essential medicines, and meets the needs of basic medicines for disease prevention and treatment
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Article 3 Essential drugs refer to drugs that meet the basic needs of disease prevention and treatment, adapt to the basic national conditions and guarantee capabilities at the current stage, have suitable dosage forms, are reasonably priced, can guarantee supply, and are fairly available
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Article 4 The State publishes the list of essential medicines, and dynamically adjusts the list of essential medicines in accordance with the clinical practice of medicines, changes in drug standards, and new listings of medicines
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Article 5 The selection of essential medicines shall be based on the functional positioning of "emphasizing basics, necessary for prevention and treatment, guaranteeing supply, priority use, guaranteeing quality, and reducing burden", adhere to the principle of equal emphasis on Chinese and Western medicines and first choice in clinical practice, and reasonably determined with reference to international experience
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Article 6 The National Essential Medicines Working Committee is responsible for coordinating and resolving important policy issues in all aspects of 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 medicines catalog, and reviewing the national essential medicines catalog
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The National Essential Medicines Working Committee consists 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, and the State It is composed of the Bureau of Disease Control and the Health Bureau of the Logistics Support Department of the Central Military Commission
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Article VII of national essential drugs, including chemical and biological products catalogs, directories, and children's medicine and other drugs list
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Article 8 The drugs included in the national essential drug list shall be those approved by the national drug regulatory authority and obtained a drug registration certificate or approval number, as well as Chinese herbal medicine prepared in accordance with national standards
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The names of chemical drugs and biological products adopt the Chinese generic names and the part of the chemical components expressed in English international non-patent drugs, and the dosage forms are listed separately; Chinese patent medicines adopt the generic names of drugs
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Article 9 The following drugs are not included in the selection scope of the National Essential Drug List:

(1) Containing national endangered wild animal and plant medicinal materials;

(2) Those that are mainly used for nourishment and health care, are easy to be abused, and are included in the national key monitoring and rational use list of drugs;

(3) Due to serious adverse reactions, the national drug regulatory authority clearly stipulates that the production, sales or use should be suspended;

(4) Violating national laws and regulations, or not meeting ethical requirements;

(5) Other conditions stipulated by the National Essential Medicines Working Committee
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Article 10 In accordance with the principles of national essential medicine selection and management, the National Health Commission is responsible for establishing an expert consultation and demonstration system, organizing the establishment of a national essential medicine expert database, and submitting it to the National Essential Medicine Working Committee for review
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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 country Consultation and evaluation of essential drugs
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Article 11 The National Health Commission drafts the National Essential Drug List selection work plan in accordance with the law, formulates specific selection rules, solicits opinions from relevant departments and parties in accordance with the law, and is reviewed by the National Essential Drug Working Committee, organized and implemented in accordance with the procedures and announced to the public
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The procedures for formulating the National Essential Medicines List are:

(1) Randomly select experts from the national essential medicine expert database to form a catalog consulting expert group and a catalog review expert group;

(2) According to disease prevention and clinical needs, the consulting expert group conducts technical evaluation of drugs through evidence-based medicine, drug clinical use monitoring, pharmacoeconomics, etc.
, proposes selection opinions, and forms a list of candidates;

(3) The evaluation expert group conducts technical demonstration and comprehensive evaluation of the candidate catalog to form the first draft of the catalog;

(4) The first draft of the catalog is sent to the member units of the National Essential Medicines Working Committee for comments, and the catalog is revised and perfected to be submitted for review;

(5) After the draft is reviewed by the National Essential Medicines Working Committee, it shall be submitted for approval according to the procedures, and the National Health Commission shall publish it and organize its implementation
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Article 12 The National Essential Drug List insists on regular evaluation and dynamic management, and the adjustment period should not exceed 3 years in principle
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When necessary, adjustments can be organized in due course with the approval of the National Essential Medicines Working Committee
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The variety and quantity to be adjusted should be determined based on the following factors:

(1) my country's basic medical and health service needs and changes in the level of basic medical security;

(2) Changes in the spectrum of diseases in my country;

(3) Monitoring and evaluation of adverse drug reactions;

(4) Drug use monitoring and clinical comprehensive evaluation;

(5) Evidence-based medicine and pharmacoeconomic evaluation of listed drugs;

(6) Other conditions stipulated by the National Essential Medicines Working Committee
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Article 13 The varieties falling into one of the following situations shall be transferred from the National Essential Drug List:

(1) Serious adverse reactions occur, or clinical diagnosis and treatment guidelines, disease prevention and control regulations have changed, and it is not suitable to be used as a national essential drug after evaluation;

(2) Based on drug clinical comprehensive evaluation or pharmacoeconomic evaluation, it can be replaced by varieties with better risk-benefit ratio or cost-benefit ratio;

(3) Other situations that the National Essential Medicines Working Committee thinks should be transferred
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Article 14 The selection and adjustment of the list of essential medicines shall follow the provisions of Articles 3, 4, 5, 7, 8, 9, and 12 of these Measures, and shall be in accordance with Articles 3, 4, 5, and 12 of these Measures.
The procedures stipulated in Article 11 shall be carried out
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The varieties that fall under the conditions stipulated in Article 13 will be brought out of the catalog after expert assessment and review by the National Essential Medicine Working Committee
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Article 15 The management of essential medicines of Chinese herbal medicines is temporarily implemented in accordance with the relevant departments of the State Council regarding the price, purchase, distribution, use, payment and reimbursement of Chinese herbal medicines
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The supply guarantee, equipment and use of drugs in the essential drug list shall be implemented in accordance with relevant laws and policies
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Article 16 Where it is necessary to determine the attribution of the national essential drug varieties, dosage forms and specifications due to reasons such as name change, different names, etc.
, the National Health Commission shall conduct the determination according to the procedures
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Article 17 The National Health Commission is responsible for establishing and improving a drug use monitoring and clinical comprehensive evaluation system focusing on essential drugs, formulating monitoring and evaluation management practices and technical guidelines, and organizing the collection and comprehensive analysis of relevant drug clinical use evidence and drug policy information , To provide evidence-based basis and technical support for the dynamic optimization of the essential medicine list and the improvement of the essential medicine equipment and management policy
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Encourage medical and health institutions to organize comprehensive clinical evaluations of drugs focusing on national essential drugs, and strengthen the analysis and application of evaluation results
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Article 18 The National Health Commission is responsible for the interpretation of these measures
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Article 19 These Measures shall be implemented as of the date of promulgation
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The "Administrative Measures for the National Essential Drug List" issued by the former National Health and Family Planning Commission on February 13, 2015 will be repealed
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