Custom Development & Manufacturing Business(For Regenerative Medicine Developers)

Why not commercialize your product in Japan first?

Japan has a ground-breaking regulatory system that is without compare, and an ideal environment is already in place for realizing productization of regenerative medicine in Japan before deployment to the rest of the world.
In 2014, the former Pharmaceutical Affairs Act was replaced by the Pharmaceuticals and Medical Devices (PMD) Act, and the new category of "regenerative medical products" was added to the existing categories of pharmaceuticals and medical devices. These products using human cells are completely different from conventional pharmaceuticals and medical devices. A system for properly evaluating and reviewing regenerative medical products made from the raw material of human cells is now being created and refined in Japan.

Three attractive aspects of the Japanese market

J-TEC's services

Contract development of regenerative medical products

Main applicable legal regulations: PMD Act *

Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960, JAPAN)

Consulting and contract manufacture of specified cell processing products

Main applicable legal regulations: RM Act *

Act on the Safety of Regenerative Medicine (Act No. 85 of 2013, JAPAN)