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

Tatsuro Hoshino; Nanami Muto; Shinsuke Tsukada; Takatoshi Nakamura; Hikoichiro Maegawa

doi: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

Medicines (Basel). 2018 Jan 6;5(1):3. doi: 10.3390/medicines5010003.

Authors

Tatsuro Hoshino¹, Nanami Muto², Shinsuke Tsukada³, Takatoshi Nakamura^{4

5}, Hikoichiro Maegawa⁶

Affiliations

¹ Office of Planning and Coordination, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan. hoshino-tatsuro@pmda.go.jp.
² Office of OTC/Quasi-drugs, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan. muto-nanami@pmda.go.jp.
³ Office of New drugs IV, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan. tsukada-shinsuke@pmda.go.jp.
⁴ Office of OTC/Quasi-drugs, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan. cba07499@nifty.com.
⁵ Division of Pharmacognosy, Phytochemistry and Narcotics, National Institute of Health Sciences, Kanagawa 210-9501, Japan. cba07499@nifty.com.
⁶ Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan. maegawa-hikoichiro@pmda.go.jp.

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.

Keywords: OTC; Pharmaceuticals and Medical Devices Agency (PMDA); herbal medicine; regulation.

Publication types

Review