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Medicines 2018, 5(1), 3; https://doi.org/10.3390/medicines5010003

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

1
Office of Planning and Coordination, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan
2
Office of OTC/Quasi-drugs, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan
3
Office of New drugs IV, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan
4
Division of Pharmacognosy, Phytochemistry and Narcotics, National Institute of Health Sciences, Kanagawa 210-9501, Japan
5
Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan
*
Author to whom correspondence should be addressed.
Received: 27 November 2017 / Revised: 27 December 2017 / Accepted: 30 December 2017 / Published: 6 January 2018
(This article belongs to the Special Issue Herbal Medicines and Functional Foods)
Full-Text   |   PDF [252 KB, uploaded 6 January 2018]

Abstract

Since the publication of “Application Guideline for Western Traditional Herbal Medicines as OTC Drugs” in 2007, only two European ethnopharmaceuticals, Vitis vinifera L., folium extract (Antistax) and Vitex agnus-castus 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. View Full-Text
Keywords: herbal medicine; regulation; OTC; Pharmaceuticals and Medical Devices Agency (PMDA) herbal medicine; regulation; OTC; Pharmaceuticals and Medical Devices Agency (PMDA)
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).
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Hoshino, T.; Muto, N.; Tsukada, S.; Nakamura, T.; Maegawa, H. 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. Medicines 2018, 5, 3.

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