How Are Japan’s Regenerative Meds Regs Playing Out?

22 Mar 2016

Nearly 18 months has passed since Japan formally adopted ground-breaking new and revised legislation governing the regulation of cell and tissue therapies in November 2014, but how is the new framework working out in practice?

TOKYO - The first two regenerative medicines were conditionally approved under Japan's new laws governing such products last September, suggesting that the nascent regulatory system is at least performing the function of allowing patients to access new therapies in an area which has been designated a flagship technology for the country.

During a panel session on the early lessons from Japan's regenerative medicine reforms at the recent BIO Asia International Conference in Tokyo, the general consensus from industry participants was that...

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