One stop shop regulatory advice service for regenerative medicine

October 13, 2014

The MHRA and HTA have announced a new ‘One stop shop’ regulatory advice service for regenerative medicine.  This follows as a response to the July 2013 House of Lords Science and Technology Committee report which called for a single source for regulatory advice for researchers, developers and manufacturers seeking to deliver regenerative therapies. The service will provide a single point of access to comprehensive and consistent advice which had previously been provided by the regulators, the Gene Therapy Advisory Committee (GTAC) and R&D staff.

Regulation of regenerative medicine spans the four health research regulatory bodies – Human Fertilisation and Embryology Authority (HFEA), Human Tissue Authority (HTA), Medical and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA).   They have now jointly established a new regulatory advice service to improve coordination and consistency of guidance for the regenerative medicine community:

Dr Rob Buckle, MRC Director of Science Programmes and Director, UK Regenerative Medicine Platform welcomed the announcement, “This new service provides a significant boost for UK regenerative medicine. By bringing together four research regulatory bodies under a single entry point, the landscape will be considerably simplified for users. This will help to smooth the translational pathway for all those UK workers engaged in regenerative medicine”

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