One stop shop regulatory advice service for regenerative medicine
13 Oct 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”.
Read the MHRA press release here.