Regulatory Requirements and Practices for Clinical Studies in Japan

Abstract

Eighty percent of the world pharmaceutical market is shared by the US, Europe and Japan. The US is the number one consumer of pharmaceuticals; Japan is number two. The total sales of ethical pharmaceuticals in Japan in 1990 was 41 billion dollars. There are more than 1,000 pharmaceutical companies in Japan and among these there are quite a few western companies. MSD, Glaxo, Pfizer, Ciba-Geigy, Hoechst, Bayer, and Roche already have a significant presence in Japan. These statistics demonstrate tremendous opportunity for Western pharmaceutical companies who want to do business in Japan. This paper describes the regulatory requirements and practices for clinical studies leading to the registration of pharmaceuticals with the Ministry of Health and Welfare—the Koseisho — in Japan. Topics covered include: organization of the Koseisho, good clinical practice (GCP) in Japan, Investigational New Drug (IND), clinical studies in Japan, and product license (PL) application by foreign companies not having significant activity in Japan.