Japan's Pharmaceutical Regulatory Reform to Overcome Drug Loss Issue.

Abstract

In recent years, there has been a significant increase in "drug loss"-the absence of drugs on the Japanese market that are already approved in countries outside of Japan-primarily due to the lack of their development in Japan. There were 86 drugs approved in Europe and the United States for which development had not yet begun in Japan. Of these, 48 (56%) were what can be termed 'venture-developed' drugs, 40 (47%) were orphan drugs, and 32 (37%) were for pediatric use. The lack of availability of