日本用于自我药疗的欧洲民族药：葡萄（Vitis vinifera L.）叶提取物和贞节树（Vitex agnus-castus L.）果实提取物作为非处方药的审查经验
European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs.
作者信息
Hoshino Tatsuro, Muto Nanami, Tsukada Shinsuke, Nakamura Takatoshi, Maegawa Hikoichiro
机构信息
Office of Planning and Coordination, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan.
Office of OTC/Quasi-drugs, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan.
出版信息
Medicines (Basel). 2018 Jan 6;5(1):3. doi: 10.3390/medicines5010003.
Since the publication of "Application Guideline for Western Traditional Herbal Medicines as OTC Drugs" in 2007, only two European ethnopharmaceuticals, L., folium extract (Antistax) and L., fructus extract (Prefemin), have been approved as OTC drugs in Japan. In this review, we describe the current regulation of Western ethnopharmaceuticals in Japan, summarize our regulatory experiences and discuss the scientific and regulatory issues involved.
自2007年《西成药作为非处方药的应用指南》发布以来，在日本仅有两种欧洲民族药物，即L.叶提取物（Antistax）和L.果实提取物（Prefemin）被批准为非处方药。在本综述中，我们描述了日本目前对西方民族药物的监管情况，总结了我们的监管经验，并讨论了其中涉及的科学和监管问题。
Zotero 插件