New legislation for regenerative medicine in Japan

22 November 2013

The Japanese legislature (Diet) has approved new legislation targeted at regenerative medicine therapies. The Regenerative Medicine Law directs the Ministry of Health, Labor and Welfare (MHLW) to adopt new procedures and rules that would accelerate the clinical development of regenerative medicine and cell therapies.

The Japanese Pharmaceutical Affairs Law (J-PAL) will now become the Pharmaceuticals and Medical Devices Act that will include a new branch for Regenerative Medicine Products. Regenerative Medicine Products will be regulated on a Fast Track process that focuses primarily on product safety.

On early assessment, Cytori sees this as important move

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