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Regulation of traditional herbal medicinal products in Japan.
J Ethnopharmacol. 2014 Dec 02; 158 Pt B:511-5.JE

Abstract

Kampo medicines are the main traditional herbal medicines in Japan and are classified as pharmaceuticals. They are based on ancient Chinese medicine and have evolved to the Japanese original style over a long period of time. Ethical Kampo formulations are prescribed in general practice by physician under the National Health Insurance reimbursement system. Over-the-counter (OTC) Kampo formulations can be purchased and used for self-medication in primary health care settings. Kampo medicines have a substantial role in the Japanese healthcare system. In the early 1970s, "The Internal Assignments on the Review for Approval of OTC Kampo Products", known as "210 OTC Kampo Formulae", was published by the Ministry of Health and Welfare (currently the Ministry of Health, Labour and Welfare). In 2008, "210 OTC Kampo Formulae" was revised and presented as "The Approval Standards for OTC Kampo Products" and now 294 Kampo formulae are listed in the standards. These products have had wide spread usage in Japan. Crude drugs and Kampo extracts have been listed in The Japanese Pharmacopoeia. Both The Approval Standards and The Quality Standards play a key role in regulation of Kampo products. "Application Guideline for Western Traditional Herbal Medicines as OTC Drugs" was published in 2007. Other ethnopharmaceuticals mostly from Europe could be approved as OTC drugs in Japan.

Authors+Show Affiliations

Office of OTC/Generic Drugs, Pharmaceuticals and Medical Devices Agency, Japan. Electronic address: maegawa-hikoichiro@pmda.go.jp.Office of OTC/Generic Drugs, Pharmaceuticals and Medical Devices Agency, Japan.Office of OTC/Generic Drugs, Pharmaceuticals and Medical Devices Agency, Japan. Electronic address: saito-kzy@ncchd.go.jp.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25043783

Citation

Maegawa, Hikoichiro, et al. "Regulation of Traditional Herbal Medicinal Products in Japan." Journal of Ethnopharmacology, vol. 158 Pt B, 2014, pp. 511-5.
Maegawa H, Nakamura T, Saito K. Regulation of traditional herbal medicinal products in Japan. J Ethnopharmacol. 2014;158 Pt B:511-5.
Maegawa, H., Nakamura, T., & Saito, K. (2014). Regulation of traditional herbal medicinal products in Japan. Journal of Ethnopharmacology, 158 Pt B, 511-5. https://doi.org/10.1016/j.jep.2014.07.012
Maegawa H, Nakamura T, Saito K. Regulation of Traditional Herbal Medicinal Products in Japan. J Ethnopharmacol. 2014 Dec 2;158 Pt B:511-5. PubMed PMID: 25043783.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regulation of traditional herbal medicinal products in Japan. AU - Maegawa,Hikoichiro, AU - Nakamura,Takatoshi, AU - Saito,Kazuyuki, Y1 - 2014/07/17/ PY - 2014/03/13/received PY - 2014/05/29/revised PY - 2014/07/08/accepted PY - 2014/7/22/entrez PY - 2014/7/22/pubmed PY - 2016/1/9/medline KW - Japan KW - Kampo KW - Regulation KW - Traditional herbal medicine SP - 511 EP - 5 JF - Journal of ethnopharmacology JO - J Ethnopharmacol VL - 158 Pt B N2 - Kampo medicines are the main traditional herbal medicines in Japan and are classified as pharmaceuticals. They are based on ancient Chinese medicine and have evolved to the Japanese original style over a long period of time. Ethical Kampo formulations are prescribed in general practice by physician under the National Health Insurance reimbursement system. Over-the-counter (OTC) Kampo formulations can be purchased and used for self-medication in primary health care settings. Kampo medicines have a substantial role in the Japanese healthcare system. In the early 1970s, "The Internal Assignments on the Review for Approval of OTC Kampo Products", known as "210 OTC Kampo Formulae", was published by the Ministry of Health and Welfare (currently the Ministry of Health, Labour and Welfare). In 2008, "210 OTC Kampo Formulae" was revised and presented as "The Approval Standards for OTC Kampo Products" and now 294 Kampo formulae are listed in the standards. These products have had wide spread usage in Japan. Crude drugs and Kampo extracts have been listed in The Japanese Pharmacopoeia. Both The Approval Standards and The Quality Standards play a key role in regulation of Kampo products. "Application Guideline for Western Traditional Herbal Medicines as OTC Drugs" was published in 2007. Other ethnopharmaceuticals mostly from Europe could be approved as OTC drugs in Japan. SN - 1872-7573 UR - https://www.unboundmedicine.com/medline/citation/25043783/Regulation_of_traditional_herbal_medicinal_products_in_Japan_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-8741(14)00516-9 DB - PRIME DP - Unbound Medicine ER -