title: Regulation of traditional herbal medicinal products in Japan.
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.affiliation: Office of OTC/Generic Drugs, Pharmaceuticals and Medical Devices Agency, Japan. Electronic address: maegawa-hikoichiro@pmda.go.jp.
authors.forename: Hikoichiro
authors.initials: H
authors.lastname: Maegawa
authors.affiliation: Office of OTC/Generic Drugs, Pharmaceuticals and Medical Devices Agency, Japan.
authors.forename: Takatoshi
authors.initials: T
authors.lastname: Nakamura
authors.affiliation: Office of OTC/Generic Drugs, Pharmaceuticals and Medical Devices Agency, Japan. Electronic address: saito-kzy@ncchd.go.jp.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Saito
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence; D006801:Humans; D007564:Japan; D007880:Legislation, Drug; D020835:Medicine, Kampo / Q000592:standards*; D004366:Nonprescription Drugs / Q000592:standards / Q000627:therapeutic use; D010602:Pharmacopoeias as Topic; D008517:Phytotherapy / Q000379:methods / Q000592:standards*; D028321:Plant Preparations / Q000592:standards* / Q000627:therapeutic use; D055553:Prescription Drugs / Q000592:standards / Q000627:therapeutic use
chemical_list: D004366:Nonprescription Drugs; D028321:Plant Preparations; D055553:Prescription Drugs
keywords: Japan; Kampo; Regulation; Traditional herbal medicine