《国家基本药物目录管理办法》政策解读

Core Viewpoint - The National Health Commission and 11 other departments have jointly issued the "National Essential Drug Directory Management Measures" to enhance the management mechanism of the national essential drug directory, ensuring the basic medical and health service drug needs of citizens [1] Group 1: National Essential Drug System - The National Essential Drug System is a fundamental part of the national drug supply security system, focusing on key clinical drugs necessary for disease prevention and treatment [2] - The system is designed to work in conjunction with basic medical and health systems and basic medical insurance systems, ensuring residents' essential drug needs are met [2] - The establishment of this system has played a significant role in improving drug supply security, promoting the rational use of drugs, and ensuring equitable access to essential medications [2] Group 2: Development and Historical Evolution - The concept of essential drugs was first proposed by the WHO in 1975, with the first essential drug list published in 1977 [3] - As of 2025, there have been 24 updates to the adult version and 10 updates to the children's version of the essential drug list, with the current adult list containing 523 drugs and the children's list containing 374 drugs [3] - China first published its essential drug list in 1982 and has made several updates since, with the current version from 2018 listing 685 drug varieties [3] Group 3: Background and Basis for Revision - The original management measures were issued in 2009 and revised in 2015, playing a crucial role in the selection and management of essential drugs [4] - Recent legal frameworks, including the Basic Medical and Health Promotion Law and the revised Drug Administration Law, have established a legal basis for the selection and management of essential drugs [4] - The revision aims to further standardize the management mechanism of the national essential drug directory and support the implementation of the Healthy China strategy [4] Group 4: Main Content of the Revised Management Measures - The revised management measures include six main aspects, such as increasing legal policy basis and optimizing the directory structure [5][6] - The directory will categorize essential drugs into chemical drugs, biological products, and traditional Chinese medicine based on clinical pharmacology and functional classification [5][6] - A dynamic adjustment mechanism will be established to ensure regular evaluations and updates of the essential drug list, with a maximum adjustment cycle of three years [6] Group 5: Selection and Adjustment Procedures - The management measures outline a clear procedure for the formulation of the essential drug directory, including the establishment of an expert database and a multi-step evaluation process [7] - Experts will conduct technical evaluations based on clinical needs and evidence-based medicine to propose a selection list, which will undergo further review and approval [7] Group 6: Monitoring and Evaluation System - A two-tiered drug use monitoring and clinical evaluation system has been established, covering all public hospitals and over 99% of government-run grassroots medical institutions [8] - The evaluation process includes multiple dimensions such as safety, effectiveness, and accessibility, providing technical support for drug selection and policy formulation [8] - Future efforts will focus on enhancing the application of monitoring and evaluation results to optimize the essential drug directory and improve management policies [8]