2019年 第5卷 第1期
《工程（英文）》 >> 2019年 第5卷 第1期 doi: 10.1016/j.eng.2018.11.012
欧盟监管环境视角下的传统医药全球化
Federal Institute for Drugs and Medical Devices, Bonn 53175, Germany
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摘要
欧盟（EU）成员国对于医药产品已经进行了统一立法，其中明确定义了草药产品和传统草药产品。目的是建立一个考虑到草药产品特殊性的监管环境。统一标准旨在协调评估并促进不同成员国进入市场。欧盟草药产品委员会（HMPC）的欧盟草药专论定义的标准和《欧洲药典》规定的质量要求代表了草药和传统药物监管环境多国协调的优秀模式。此外，该框架至少部分适用于包含于中药（TCM）中的中草药和传统药物，以便进入欧盟市场。此外，HMPC还就中草药安全性和有效性的专论提供了具体的指导文件和试点项目。在《欧洲药典》中，与中药相关的草药质量的专论数量不断增加。这些发展表明与中药相关的全球化是一个持续的过程。相关监管机构、科学界和感兴趣的利益相关者之间的沟通与合作将为各种监管环境的融合奠定基础。这将有助于在适当标准的基础上在世界范围内运用传统药物。
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