| 罗卫花,徐敢.中药材管理属性和科学监管探索[J].中国药事,2024,38(9):994-1000 |
| 中药材管理属性和科学监管探索 |
| Exploration on Management Attributes and Scientific Management of Chinese Herbal Medicines |
| 投稿时间：2024-04-10 |
| DOI：10.16153/j.1002-7777.20240282 |
| 中文关键词: 中药材 中药饮片 科学监管 管理属性 协同治理 |
| 英文关键词: Chinese herbal medicines Chinese herbal decoction pieces scientifi c management management attributes collaborative management |
| 基金项目:中国药品监督管理研究会研究课题项目（编号 BUCM-2023-KJ-GL-008）；国家药品监督管理局中国药品监管科学行动计划第二批重点项目（编号国药监科外〔2021〕37号）；北京中医药大学纵向科研发展基金支持 |
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| 中文摘要: |
| 目的：明确中药材管理属性和科学内涵，探索中药材科学监管和高质量发展路径。方法：通过文献分析和实践案例研究，明确中药材管理属性和监管中存在的问题，结合问卷调查探讨中药材监管路径和方法。结果与结论：实践中中药材具备多重身份，法律法规对中药材属性也并未予以明确，建议建立单独的中药材管理规定以明确中药材管理属性。针对中药材使用的广泛性和特殊性，建议从全生命周期角度科学界定中药材，并加强中药材协同治理。同时对中药材开展科学的分类管理，以保障群众用药安全，推动中药科学监管。 |
| 英文摘要: |
| Objective: To clarify the management attributes and scientific connotation of Chinese herbal medicines, and to explore the scientific management and high-quality development path of Chinese herbal medicines. Methods: Through literature analysis and practical cases study, the management attributes and problems existing in supervision of Chinese herbal medicines are clarified, and the regulatory paths and methods of Chinese herbal medicines are discussed in combination with questionnaire survey. Results and Conclusion: Chinese herbal medicines have multiple identities in practice, and the attributes of Chinese herbal medicines are not clearly defined in laws and regulations. Therefore, separate regulations on the management of Chinese herbal medicines should be established to clarify the attributes of Chinese herbal medicines. Regarding the universality and particularity of Chinese herbal medicines use, it is suggested to scientifically defi ne Chinese herbal medicines from the perspective of life cycle and strengthen the collaborative management of Chinese herbal medicines. At the same time, scientific classification management of Chinese herbal medicines should be carried out to ensure the safety of people's medication and promote the scientific management of Chinese herbal medicines. |
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