Scoholarly Articles about Complementary and Alternative Medicine
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J Intercult Ethnopharmacol. 2017 6(3):333-338 doi: 10.5455/jice.20170713091550.

Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan.

Layla Somekawa; Hikoichiro Maegawa; Shinsuke Tsukada; Takatoshi Nakamura

Office of OTC/Quasi-drugs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.; Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.; Office of New drugs IV, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.; Office of OTC/Quasi-drugs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

ABSTRACT
: Currently, there are no standardized regulatory systems for herbal medicinal products worldwide. Communication and sharing of knowledge between different regulatory systems will lead to mutual understanding and might help identify topics which deserve further discussion in the establishment of common standards. Regulatory information on traditional herbal medicinal products in Japan is updated by the establishment of Application Guidance for over-the-counter non-Kampo Crude Drug Extract Products. We would like to report on updated regulatory information on the new Application Guidance. Methods for comparison of Crude Drug Extract formulation and standard decoction and criteria for application and the key points to consider for each criterion are indicated in the guidance. Establishment of the guidance contributes to improvements in public health. We hope that the regulatory information about traditional herbal medicinal products in Japan will be of contribution to tackling the challenging task of regulating traditional herbal products worldwide.

KEYWORDS: Pharmaceuticals and Medical Devices Agency (PMDA); regulation; traditional herbal medicine

Article Type: Journal Article

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Scoholarly Articles about Complementary and Alternative Medicine