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
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 thi...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2018-01-01
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| Series: | Medicines |
| Subjects: | |
| Online Access: | http://www.mdpi.com/2305-6320/5/1/3 |
| _version_ | 1811283440021012480 |
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| author | Tatsuro Hoshino Nanami Muto Shinsuke Tsukada Takatoshi Nakamura Hikoichiro Maegawa |
| author_facet | Tatsuro Hoshino Nanami Muto Shinsuke Tsukada Takatoshi Nakamura Hikoichiro Maegawa |
| author_sort | Tatsuro Hoshino |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T02:11:23Z |
| format | Article |
| id | doaj.art-7d2b18a6ff69421e8edbfb7a075ff703 |
| institution | Directory Open Access Journal |
| issn | 2305-6320 |
| language | English |
| last_indexed | 2024-04-13T02:11:23Z |
| publishDate | 2018-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Medicines |
| spelling | doaj.art-7d2b18a6ff69421e8edbfb7a075ff7032022-12-22T03:07:16ZengMDPI AGMedicines2305-63202018-01-0151310.3390/medicines5010003medicines5010003European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC DrugsTatsuro Hoshino0Nanami Muto1Shinsuke Tsukada2Takatoshi Nakamura3Hikoichiro Maegawa4Office of Planning and Coordination, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, JapanOffice of OTC/Quasi-drugs, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, JapanOffice of New drugs IV, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, JapanOffice of OTC/Quasi-drugs, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, JapanOffice of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, JapanSince 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.http://www.mdpi.com/2305-6320/5/1/3herbal medicineregulationOTCPharmaceuticals and Medical Devices Agency (PMDA) |
| spellingShingle | Tatsuro Hoshino Nanami Muto Shinsuke Tsukada Takatoshi Nakamura Hikoichiro Maegawa 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 herbal medicine regulation OTC Pharmaceuticals and Medical Devices Agency (PMDA) |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | herbal medicine regulation OTC Pharmaceuticals and Medical Devices Agency (PMDA) |
| url | http://www.mdpi.com/2305-6320/5/1/3 |
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