Regulation of Generic Drugs in Japan

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By Ryosuke Kuribayashi, Maki Matsuhama, and Kenichi Mikami

Ryosuke KuribayashiMaki MatsuhamaA generic drug is defined as a drug with the same active pharmaceutical ingredient, dosage form, strength, quality, indication, effect, direction, and dose as the original proprietary drug. Generic drug approval review in Japan is conducted by the Office of Generic Drugs, established in November 2014 as part of the Pharmaceuticals and Medical Devices Agency (PMDA), which reviews the equivalence of the original drugs from the viewpoint of quality, efficacy, and safety, based on documentation submitted by the generic drug applicants.

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