Japan, the world's second-largest pharmaceutical market, presents a lucrative opportunity for global pharmaceutical companies. This white paper provides an in-depth analysis of Japan's regulatory environment, highlighting the recent trends that make Japan an attractive market for foreign investment. It outlines the roles of the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) in drug regulation, emphasizing the importance of understanding Japan's unique regulatory requirements. It details the submission procedures for Investigational New Drug (IND) applications, New Drug Applications (NDAs), and post-approval submissions, including the specific requirements for generic drugs and the fast track approval process for priority review products. The paper also addresses Japan's specific submission standards, including language requirements and electronic submission protocols. The conclusion underscores Japan's evolving market, which is becoming more open to foreign companies due to harmonization with US and EU regulatory regimes and a government push for increased generic drug use.
Fill the form below to download the White Paper
