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首页> 美国卫生研究院文献>Journal of Intercultural Ethnopharmacology >Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan
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Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan

机译：在日本建立OTC非坎普原油原料提取产品的应用指南

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Currently, there are no standardized regulatory systems for herbal medicinal products worldwide. Communication and sharing of knowledge between different regulatory systems will lead to mutual understanding and might help identify topics which deserve further discussion in the establishment of common standards. Regulatory information on traditional herbal medicinal products in Japan is updated by the establishment of Application Guidance for over-the-counter non-Kampo Crude Drug Extract Products. We would like to report on updated regulatory information on the new Application Guidance. Methods for comparison of Crude Drug Extract formulation and standard decoction and criteria for application and the key points to consider for each criterion are indicated in the guidance. Establishment of the guidance contributes to improvements in public health. We hope that the regulatory information about traditional herbal medicinal products in Japan will be of contribution to tackling the challenging task of regulating traditional herbal products worldwide.
机译：目前，全世界没有针对草药的标准化管理体系。不同监管体系之间的交流和知识共享将导致相互理解，并可能有助于确定在建立通用标准时应进一步讨论的主题。通过制定非处方非坎普原油原料提取产品的应用指南，可以更新日本传统草药产品的法规信息。我们想报告有关新应用指南的最新监管信息。指南中指出了原药提取物制剂和标准汤剂的比较方法以及应用标准和每个标准要考虑的重点。制定指南有助于改善公共卫生。我们希望，日本有关传统草药产品的法规信息将有助于应对全球范围内规范传统草药产品的艰巨任务。

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