Chin Med:中草药进入欧盟市场的关键质量因素

2022-07-31 August MedSci原创

中草药(CHMs)在防治疾病方面具有得天独厚的优势,在世界范围内得到广泛认可。越来越多的 CHM 在国际市场上越来越受欢迎。然而,CHMs的质量控制是其在国际市场上被接受和认可的一个重要问题。

随着中医药在世界范围内的应用,中药迅速进入国际市场。同时,它们的科学证据、安全问题/可能的毒性和质量问题也引起了广泛关注。为了保护消费者的健康利益,一些国家和地区已经开始在其国家药典和地区标准中建立中药质量标准。在欧洲,自 2009 年起,中医药工作组在欧洲药典(Ph. Eur.)中逐步建立和阐述了中草药质量专论。

Ph. Eur 中的草药提取物:

欧洲药品监管体系基于来自欧洲经济区国家的监管机构网络:欧盟委员会、欧洲药品管理局 (EMA) 和欧洲药品质量与卫生保健理事会 (EDQM),使欧盟监管体系在世界上独一无二。在该系统中,EMA 和 EDQM 在药品注册和质量管理中发挥核心作用。

EDQM 和 EMA 在欧盟草药产品监管中的不同作用:

欧盟中草药产品的传统用途注册:

中药材生产的各个环节都需要对中药材进行质量控制:

综上所述,中药的质量要求在中药国际化中起着至关重要的作用。特别是一些国家的药典对中药质量控制提出了基本要求,成为这些国家中药材市场准入的门槛。比较不同药典中中药材的质量标准,可以明显看出它们在中药材的种类、数量以及各论规定的项目方面存在差异。与西医相比,中药有其独特之处。需要在中医理论体系的指导下配合使用。这应考虑到 CHM 制剂的质量控制。通过对中国和欧盟CHMs关键质量因素的比较,探讨了在质量要求和法规方面的异同,为CHMs进入欧盟市场提供了参考。如何将西方医学与中医理论和哲学联系起来仍然被认为是一个挑战。中医的防治策略是多靶点、非线性方法。不同学科与系统药理学相结合的研究可能为未来的医学科学提供一些启示。

原文:Wang M, Yao PF, Sun PY, Liang W, Chen XJ. Key quality factors for Chinese herbal medicines entering the EU market. Chin Med. 2022 Feb 22;17(1):29. doi: 10.1186/s13020-022-00583-x. PMID: 35193628; PMCID: PMC8861989.

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    2023-06-12 zll0637
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    2022-07-31 ms5000000518166734

    学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习

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    2022-07-31 ms2000000187101769

    中医药研究加油!

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