Is the new essential medicine list coming? The "Essential Medicine List Management Measures" proposes alignment with centralized procurement and other policies.

The work to adjust the Basic Drugs List has received a major new document!

On February 11, the National Health Commission, National Development and Reform Commission, Ministry of Industry and Information Technology, Ministry of Finance, Ministry of Commerce, State Administration for Market Regulation, National Healthcare Security Administration, and other 11 departments jointly issued the “Measures for the Administration of the National Basic Drugs List” (hereinafter referred to as the “Measures”), which took effect upon issuance. The previous “Measures for the Administration of the National Basic Drugs List” issued by the former National Health and Family Planning Commission on February 13, 2015, is simultaneously repealed.

After 11 years, the new “Measures” propose six revisions, including improving the list management mechanism, aligning the supply and use of basic drugs with policies such as hierarchical diagnosis and treatment, centralized drug procurement, and reimbursement; emphasizing the clinical value of drugs, and clarifying changes based on disease spectrum shifts, clinical application practices, drug standards, and new drug listings.

At the same time, the “Measures” also clarify that the procedure for developing the Basic Drugs List (hereinafter referred to as the “List”) involves: first, establishing a national expert database for basic drugs, and randomly selecting experts to form the list consultation expert group and the list review expert group; second, consulting experts evaluate drugs based on evidence-based medicine, drug use monitoring, pharmacoeconomics, and other technical assessments related to disease prevention and clinical needs, to propose selection opinions and form a candidate list; third, review experts conduct technical demonstrations and comprehensive evaluations of the candidate list to produce an initial draft; fourth, the initial draft is circulated among members of the National Basic Drugs Work Coordination Mechanism for comments, revised, and finalized into a draft for review; fifth, after review and approval by the mechanism, the list is officially approved, announced, and implemented.

In 1975, the World Health Organization (WHO) first proposed the concept of essential drugs, aiming to ensure that most of the population in developing countries can access key medicines necessary for health care, which is an important measure to safeguard the safety of national drug production and supply. In 1982, China first published the Basic Drugs List, which has been updated five times by 2004. In 2009, the CPC Central Committee and the State Council issued the “Opinions on Deepening the Reform of the Medical and Health System,” establishing a drug supply guarantee system based on the basic drugs system, with the central government uniformly formulating and publishing the national basic drugs list. That same year, the 2009 edition of the list was issued, with updates in 2012 and 2018.

The current “National Basic Drugs List” is the 2018 version, containing 685 drug varieties, including 417 chemical drugs and biologics, and 268 traditional Chinese medicines, unchanged for eight years. In recent years, there have been multiple reports about adjustments to the basic drugs list. For example, in a reply to Proposal No. 8016 from the Third Session of the 14th National People’s Congress in September 2025, the National Health Commission mentioned: “In accordance with the requirements of the ‘Measures for the Administration of the National Basic Drugs List,’ experts will be organized to evaluate during the adjustment process, based on clinical practice, changes in drug standards, new drug listings, etc., to scientifically,规范, and orderly adjust the list.”

This “Measures” does not officially publish the updated list of the new basic drugs, but its issuance is seen by industry insiders as a significant signal for the list adjustment. The “Measures” and related department interpretations did not specify when the new list would be announced, but emphasized that the list will undergo regular assessments and dynamic management, with an adjustment cycle generally not exceeding three years. When necessary, and with approval from the mechanism, timely adjustments can be organized.

A domestic pharmaceutical industry insider told The Paper that the current list is still the 2018 version, and many drugs are quite old. Many new drugs approved after 2018 have better efficacy and prices. They are more concerned about the specific principles for list adjustment, such as “aligning with policies like centralized procurement,” and whether this means that all or most products in future procurement will be directly included in the list. Or whether procurement drugs’ assessments will not count towards the basic drugs list evaluation. Many details are still unclear, and they look forward to further official information.

The insider further explained that basic drugs can be understood as commonly used medicines that meet the basic healthcare needs of medical institutions, with clear drug proportion assessments. Different levels of medical institutions have different evaluation standards for the proportion of basic drugs. For pharmaceutical companies, having a product designated as a basic drug makes it easier to enter hospitals. Who gets in or out will deeply impact the companies behind the products and even the market landscape, which is worth关注 and期待.

The “Measures” states that drugs included in the national basic drugs list must be approved by the National Medical Products Administration and have obtained a drug registration certificate, as well as be prepared according to national drug standards. Except for emergency (rescue) drugs, exclusive production varieties included in the list should undergo separate demonstration. The names of chemical drugs and biologics are expressed using the Chinese generic name and the international non-proprietary name (INN) in English, with dosage forms and specifications listed separately; traditional Chinese medicines use their generic names. Drugs containing endangered wild plants and animals, mainly used for health supplements, or drugs that have been suspended from production, sale, or use due to serious adverse reactions, as well as those violating national laws or ethical standards, are not included in the list.

The “Measures” also propose that, following the principles of “highlighting basic, essential for prevention and treatment, ensuring supply, prioritizing use, guaranteeing quality, and reducing burden,” the selection and adjustment of basic drugs should adhere to the principles of integrating traditional Chinese medicine and Western medicine, using both, and clinical first choice, with reference to international experience. Zhang Tingjie, founder of Fengyun Yao Tan, pointed out that the rules for adjusting the list proposed in the “Measures” are not particularly special, and since the final list has not been released, it’s hard to discuss specific impacts. However, it is certain that changes to the basic drugs list will trigger a series of new market shifts.

(Article source: The Paper)