Regenerative medicine Manufacturing

The new regulations (after 25th Dec, 2014) can be summarized as follows.

Domestic Manufacturing(Domestic Manufacturer): Manufacturing license is required for manufacturing a product in Japan.; Manufacturing license is requiredfor storing product prior to consignment.; Manufacturing license is required for the OEM when the partial production is done by OEM.

Foreign Manufacturing (Foreign Manufacturer): Manufacturing license is required when a product is imported.; Manufacturing environment may differ.; Product categorization may differ. The regenerative medical products in overseas countries may not be eligible in Japan.