E-ISSN 2577-5669
 

Review Article 


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

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

Cited by (1)

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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How to Cite this Article
Pubmed Style

Layla Somekawa, Hikoichiro Maegawa, Shinsuke Tsukada, Takatoshi Nakamura. Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan. J Complement Med Res. 2017; 6(3): 333-338. doi:10.5455/jice.20170713091550


Web Style

Layla Somekawa, Hikoichiro Maegawa, Shinsuke Tsukada, Takatoshi Nakamura. Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan. http://www.jocmr.com/?mno=264034 [Access: February 15, 2020]. doi:10.5455/jice.20170713091550


AMA (American Medical Association) Style

Layla Somekawa, Hikoichiro Maegawa, Shinsuke Tsukada, Takatoshi Nakamura. Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan. J Complement Med Res. 2017; 6(3): 333-338. doi:10.5455/jice.20170713091550



Vancouver/ICMJE Style

Layla Somekawa, Hikoichiro Maegawa, Shinsuke Tsukada, Takatoshi Nakamura. Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan. J Complement Med Res. (2017), [cited February 15, 2020]; 6(3): 333-338. doi:10.5455/jice.20170713091550



Harvard Style

Layla Somekawa, Hikoichiro Maegawa, Shinsuke Tsukada, Takatoshi Nakamura (2017) Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan. J Complement Med Res, 6 (3), 333-338. doi:10.5455/jice.20170713091550



Turabian Style

Layla Somekawa, Hikoichiro Maegawa, Shinsuke Tsukada, Takatoshi Nakamura. 2017. Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan. Journal of Complementary Medicine Research, 6 (3), 333-338. doi:10.5455/jice.20170713091550



Chicago Style

Layla Somekawa, Hikoichiro Maegawa, Shinsuke Tsukada, Takatoshi Nakamura. "Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan." Journal of Complementary Medicine Research 6 (2017), 333-338. doi:10.5455/jice.20170713091550



MLA (The Modern Language Association) Style

Layla Somekawa, Hikoichiro Maegawa, Shinsuke Tsukada, Takatoshi Nakamura. "Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan." Journal of Complementary Medicine Research 6.3 (2017), 333-338. Print. doi:10.5455/jice.20170713091550



APA (American Psychological Association) Style

Layla Somekawa, Hikoichiro Maegawa, Shinsuke Tsukada, Takatoshi Nakamura (2017) Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan. Journal of Complementary Medicine Research, 6 (3), 333-338. doi:10.5455/jice.20170713091550