Abstract
This paper provides an overview of the Japanese pharmaceutical industry and the Japanese regulatory authority, the Ministry of Health and Welfare. Within the ministry, the Pharmaceutical Affairs Bureau is responsible for pharmaceutical administration. The relationship between Japan's 47 prefectural governments, each of which has a pharmaceutical division responsible for pharmaceutical administration within the prefecture, and the Pharmaceutical Affairs Bureau, is explained. Japan's inspection system, based on the Pharmaceuticals Affairs Law and good manufacturing practice (GMP), is also covered.
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