Kampo pharmaceutical products in the Japanese health‐care system: Legal status and quality assurance

Abstract

ABSTRACTObjectiveTo accurately present the current situation regarding traditional Japanese medicines (kampo medicines), especially their legal status and quality assurance, and to resolve the misunderstanding regarding kampo medicine.Legal statusKampo medicines have been approved as official medicines by the Japanese government; they are covered by national health insurance and are used regularly in the standard health‐care system in Japan. Kampo medicines accounted for approximately 2.4% of Japan's total pharmaceutical sales in 2015, and the majority were dry extract products for prescription. Currently, 148 of ethical Kampo formulations are covered by the national insurance system, and the official approval standards for over‐the‐counter kampo products have been established for 294 formulations.Quality assuranceThe Japanese Pharmacopoeia (JP) contains monographs on almost all the crude drugs that are the raw materials for kampo medicines. The quality of kampo extract products is ensured through the equivalence of dry extract and two or more marker components with decoction (standard decoction). The JP also contains monographs on formulation extracts that have high sales volumes. For manufacturing, kampo good manufacturing practice (GMP), the self‐imposed standard of the Federation of Pharmaceutical Manufacturers' Associations of Japan, has been instituted in addition to the standard GMP for conventional medicines. The quantity of pesticide residues, heavy metals and arsenic, and microorganisms in Kampo products and crude drugs is controlled by the JP and manufacturers' voluntary standards.ConclusionKampo medicines are approved as a legal pharmaceutical product of Japan and their quality is highly assured by Japanese authorities and each manufacturer.