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

Layla Somekawa, Hikoichiro Maegawa, Shinsuke Tsukada, Takatoshi Nakamura.

Abstract
Currently, there is 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 establishment of common standards. Regulatory information on traditional herbal medicinal products in Japan is updated by establishment of Application Guidance for OTC 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 criteria are indicated in the guidance. Establishment of the guidance contribute to improvements in public health. We hope that the regulatory information about traditional herbal medicinal products in Japan will be of contribution in tackling the challenging task of regulating traditional herbal products worldwide.

Key words: Traditional herbal medicine; Regulation; PMDA



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