| 庄辉,王德才,梁海岩,宋光胜.中药配方颗粒监管存在的问题与对策[J].中国药事,2023,(7):757-763 |
| 中药配方颗粒监管存在的问题与对策 |
| Problems and Countermeasures in the Supervision of Traditional Chinese Medicine Formula Granules |
| 投稿时间：2023-02-19 |
| DOI：10.16153/j.1002-7777.2023.07.004 |
| 中文关键词: 中药配方颗粒 监管 问题 对策 |
| 英文关键词: traditional Chinese medicine formula granules regulation problem countermeasure |
| 基金项目: |
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| 摘要点击次数: 547 |
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| 中文摘要: |
| 目的：为中药配方颗粒产业健康发展和监管工作提供参考。方法：回顾国内外中药配方颗粒产业和监管情况，分析我国中药配方颗粒产业和监管存在的问题，提出相关对策。结果与结论：随着国家对传统中医药产业的重视，中医药利好政策不断发布，中药配方颗粒行业迎来快速发展期，且在生产、流通和使用方面逐步规范。然而市场份额的快速增长，对中药配方颗粒研发、生产、流通、使用等各环节的监管带来挑战。中药配方颗粒生产企业和使用单位应加强质量管理，药品监管部门应对中药配方颗粒的生产、流通、使用等方面加强监管，以保证中药配方颗粒质量安全有效，满足人民群众多样化的健康需求。 |
| 英文摘要: |
| Objective: To provide a reference for the healthy development and supervision of Chinese medicine formula granule industry. Methods: Based on the review of the industry and supervision of traditional Chinese medicine formula granule at home and abroad, the existing problems in the industry and supervision of traditional Chinese medicine formula granule were analyzed, and relevant countermeasures were put forward. Results and Conclusion: As the country attaches importance to the traditional Chinese medicine industry, favorable policies on traditional Chinese medicine have been released, the Chinese medicine formula granule industry ushered in a period of rapid development, and gradually standardized in production, circulation and use. However, the rapid growth of market share has brought challenges to the supervision of various aspects such as the research and development, production, circulation and use of TCM formula granules. Manufacturers and users of TCM formula granules should strengthen quality control, and drug regulatory authorities should strengthen supervision over the production, circulation and use of TCM formula granules, so as to ensure the safety and eff ectiveness of the quality of TCM formula granules and meet the diversifi ed health needs of the people. |
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