Volume 158, Part B, 2 December 2014, Pages 511–515
Regulation of herbal and traditional medicinal products – European and global strategies (International Symposium TradReg2013)
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.
Graphical abstract
Abbreviations
- GMP, Good Manufacturing Practice;
- JKMA, Japan Kampo Medicines Manufactures Association;
- JP, The Japanese Pharmacopoeia;
- JPEC, Japan Pharmacists Education Center;
- MHLW, Ministry of Health, Labour and Welfare;
- MHW, Ministry of Health and Welfare;
- NHI, National Health Insurance;
- PMDA, Pharmaceuticals and Medical Devices Agency
Keywords
- Traditional herbal medicine;
- Kampo;
- Regulation;
- Japan
- Correspondence
to: Office of Vaccines and Blood Products, Pharmaceuticals and Medical
Devices Agency, Shin-kasumigaseki Building, 3-3-2, Kasumigaseki,
Chiyoda-ku, Tokyo, 100-0013, Japan. Tel.:
+81 3 3506 9449; fax: +81 3 3506 9495.
- 1
- Present
address: Department of Research and Development, National Center for
Child Health and Development, 2–10-1 Okura, Setagaya-ku, Tokyo,
157–8535, Japan. Tel.: +81 3 3416 0181; fax: +81 3 5494 7161.
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