The 2021 edition of the basic medicine catalog management method is released!

On November 15, 2021, the Department of Pharmaceutical Affairs of the National Health Commission issued a document to solicit opinions on the "National Essential Drug List Management Measures (Revised Draft)", and the deadline for feedback is December 14, 2021
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The draft pointed out that the national essential medicines include a catalog of chemical medicines and biological products, a catalog of Chinese medicines, and a catalog of children's medicines
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Chemical drugs and biological products are mainly classified according to clinical pharmacology, Chinese patent medicines are mainly classified according to function, and children's medicines are mainly classified according to children's specific applicable medicines
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It is worth noting that “children’s medicines” have been newly added to the range of basic medicines.
The industry pointed out that children’s medicines have been facing shortages in clinical practice.
The explicit addition of children’s medicines this time may improve this phenomenon and protect children’s medicines.
Demand is good for mature varieties and so on
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Moreover, China’s basic medicine catalog has no catalogues for children’s medicines.
This new addition means that it is in line with international standards.
Therefore, it is beneficial to the products in the WHO children’s medicine list and Chinese patent medicines for children’s medicines
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According to this document, the drugs included in the national basic drug list should be those approved by the national drug regulatory authority and have obtained a drug registration certificate or approval number, as well as Chinese herbal medicine prepared in accordance with national standards
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Except for emergency (rescue) medicines, the inclusion of exclusive production varieties into the national essential medicines list should be independently demonstrated
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Compared with the previous out of the industry, "except for emergency medicines, exclusive varieties should be independently demonstrated, classic prescriptions and consistency evaluations should be included in priority (may not be medical insurance drugs)", this new consultation draft has been removed The option of "Classic Famous Formulas and Over-rated Varieties Prioritized for Inclusion" was added
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In addition, these 5 types of drugs are not included in the selection scope of the National Essential Drug List: 1.
Those containing national endangered wild animals and plants; 2.
Those mainly used for nourishing and health care, easy to abuse, and included in the national key monitoring and rational use of drugs; 3.
1.
Due to serious adverse reactions, the national drug regulatory authority clearly stipulates that the production, sales or use is suspended; 4.
Violates national laws, regulations, or does not meet ethical requirements; 5.
Other circumstances specified by the National Essential Medicines Working Committee
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According to the analysis of industry insiders, in the review, the basic medicine has obviously borrowed from the "double-envelope bidding procurement model", that is, first formulating policies (selecting work plans), then double-envelope review (technical evaluation + technical demonstration), and finally publicizing (soliciting opinions).
Then submit for review
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In addition, regarding the adjustment time that the industry is concerned about, the answer is also given in the document
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The document pointed out that the National Essential Drug List insists on regular evaluation and dynamic management, and the adjustment cycle 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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On November 16, 2020, at the discussion meeting for soliciting opinions on the management measures of the National Essential Medicine List, five key considerations for the adjustment of essential medicines in 2021 were predicted: 1.
The use of infectious diseases; 2.
Chronic diseases and cancer and tumor transformation Drugs for chronic diseases; 3.
Drugs for common diseases; 4.
Disease-oriented.
If there is indeed no medicine available for patients, and symptomatic treatment is needed, choose the most appropriate range; 5.
Mainly look at the product value and the improvement of clinical endpoint indicators.
The long-term quality of life of patients can be improved, and the standard of curing is
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According to this consultation, the types and quantities of adjustments should be determined based on six major factors: 1.
China's basic medical and health service needs and basic medical security level changes; 2.
China's disease spectrum changes; 3.
Adverse drug reaction monitoring and evaluation; 4.
1.
Drug use monitoring and clinical comprehensive evaluation; 5.
Evidence-based medicine and pharmacoeconomic evaluation of marketed drugs; 6.
Other conditions specified by the National Essential Medicines Working Committee
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It is not difficult to see that the considerations in the variety and quantity of adjustments are significantly different from the five major directions considered at the previous meeting
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The news of the adjustment of the essential medicines catalogue continued to spread in 2020.
China began to implement the essential medicine catalogue system in 2009.
Since then, the number of medicines covered has been continuously increasing.
There were only 307 kinds in the 2009 edition and 520 kinds in the 2013 edition.
, The 2018 edition expanded to 685 species again
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According to the plan of adjustment once every three years, it is expected that the new version of the basic medicine catalog will also start the adjustment work in the near future
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Previously, some experts suggested that basic medicines should gradually meet the requirements of 90%, 80%, and 60% of hospitals, and that the number of basic medicines should be 900 to meet the policy requirements
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The "magic drug" has accelerated its exit, and products with high clinical value are expected to enter.
The adjustment of the new version of the basic drug catalog is worthy of attention
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Attachment: Measures for the Administration of the National Essential Medicines List (Revised Draft) Article 1 is to promote the implementation of the Healthy China Strategy, consolidate and improve the national essential medicine system, further standardize and improve the national essential medicines catalog management mechanism, and guarantee basic medical and health services for citizens.
The Basic Medical Hygiene and Health Promotion Law of the Republic, the Drug Administration Law of the People’s Republic of China, and other legal provisions, and the Opinions of the General Office of the State Council on Improving the National Essential Drug System, and the General Office of the State Council on Further Doing a Good Job in Guaranteeing Supply and Stabilizing Prices of Drugs in Shortage Opinions and other documents are deployed to formulate this approach
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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 drug listings
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The management of the essential drug list shall be scientific, fair, open and transparent, extensively listen to opinions and suggestions from all walks of life, and accept social supervision
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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 determine with reference to international experience
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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 medicines 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 State Administration for Market Regulation, 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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The office is located in the National Health Commission and is responsible for the daily work of the National Essential Medicines Working Committee
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Each member unit undertakes specific matters concerning the selection and adjustment of national essential medicines and the implementation of the system within the scope of their duties
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Article 7 The national essential medicines include the catalog of chemical medicines and biological products, the catalog of Chinese medicines, and the catalog of children's medicines
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Chemical drugs and biological products are mainly classified according to clinical pharmacology, Chinese patent medicines are mainly classified according to function, and children's medicines are mainly classified according to children's specific applicable medicines
.
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
.
Except for emergency (rescue) medicines, the inclusion of exclusive production varieties into the national essential medicines list should be independently demonstrated
.
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 animals and plants; (2) Mainly used for nourishment and health care, easy to abuse, and included in the national key monitoring and rational use of drugs; (3) Due to serious adverse reactions, the national drug regulatory authority clearly stipulates the suspension of production, sales or use; (4) Violation of national laws, regulations, or ethical requirements; (5) Other circumstances specified 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 reporting 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 medicine list are: (1) Randomly select experts from the national essential medicine expert database to establish a catalog consultation expert group and catalog review expert group; Perform technical evaluations of drugs, put forward selection opinions, and form candidate catalogs; (3) The evaluation expert group conducts technical demonstration and comprehensive evaluation of the candidate catalogs 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 form a draft for review; Organization and implementation
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Article 12 The National Essential Drug List insists on regular evaluation and dynamic management, and the adjustment period shall not exceed 3 years in principle
.
When necessary, after review and approval by the National Essential Medicines Working Committee, adjustments can be organized in due course
.
The types and quantities of adjustments should be determined based on the following factors: (1) China's basic medical and health service needs and basic medical security level changes; (2) China's disease spectrum changes; (3) Adverse drug reaction monitoring and evaluation; (4) Drug use monitoring And clinical comprehensive evaluation; (5) Evidence-based medicine and pharmacoeconomic evaluation of marketed drugs; (6) Other conditions specified by the National Essential Medicines Working Committee
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Article 13 The varieties that fall into one of the following situations shall be removed from the national essential medicine list: (1) Serious adverse reactions occur, or clinical diagnosis and treatment guidelines, disease prevention and control regulations have changed, and they are not suitable to be used as national essential medicines after evaluation Used; (2) Based on the comprehensive clinical evaluation or pharmacoeconomic evaluation of drugs, it can be replaced by varieties with better risk-benefit ratio or cost-benefit ratio; (3) Other circumstances that the National Essential Medicines Working Committee deems should be transferred
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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 in accordance with Article 3 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 evaluation 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 For reasons such as name change, different names, etc.
, it is necessary to confirm the attribution of the national essential drug varieties, dosage forms and specifications, etc.
, the National Health Commission shall conduct the confirmation according to the procedures. .
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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