Abstract
EFPIA Japan and PhRMA Japan conducted a joint questionnaire survey for development of regenerative medical products. In November 2014, regenerative medical products were newly defined by the Pharmaceutical and Medical Device Act, and conditional/time-limited approval system was also legislated in Japan leading the world. This new legislation, however, does not seem to direct foreign-affiliated pharmaceutical companies to proactively engage into development activities in Japan. For that reason, this joint survey was planned to understand the present situation of introduction for regenerative medical products from Headquarters and also to find issues and/or concerns on development in Japan. Twenty nine out of thirty three EFPIA Japan or PhRMA Japan member companies responded on this survey (88% on response rate). Fourteen companies (48%) had regenerative medical products in Headquarters. Total number of under development or launched products were 31, and 12 out of them were introduced or planned to introduce into Japan. The detailed investigation revealed a large development gap especially for the products which had already begun clinical trial in Headquarters. It implied a drug lag in future. Regarding issues and/or concerns to introduce the products into Japan, CMC and quality related matters were the most frequent, followed by domestic regulation like Cartagena law and uncertainty of business case.
