Moves to ease regulatory burden for regenerative medicine

20 October 2014

A new service for ‘comprehensive and consistent’ regulatory advice on regenerative medicine has been launched in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA).

Four different regulatory bodies include aspects of regenerative medicine within their remit; in addition to the MHRA and HRA, the Human Fertilisation and Embryology Authority (HFEA) and Human Tissue Authority (HTA) are also involved.

Now the MHRA Innovation Office will provide a single ‘one stop shop’ for free regulatory advice; previously advice could be sought from each of the four regulators plus the Gene Therapy Advisory Committee (GTAC). This change has been taken in response to a 2013 House of Lords Science and Technology Committee report on regenerative medicine, which criticised the complexity of the UK regulatory environment and called for a single source of regulatory advice.

MHRA Chief Executive Dr Ian Hudson said: “This joined up approach to advice, combined with other UK life sciences initiatives such as the MHRA Early Access Scheme, will further bolster the UK’s position as a world leader in the development of advanced therapies”. A potential cancer drug was the first therapy to be awarded ‘Promising Innovative Medicine’ (PIM) designation as part of the Early Access Scheme to fast-track access to patients last month.

Dr Rob Buckle, Director of the UK Regenerative Medicine Platform, also welcomed the announcement as a significant boost for UK regenerative medicine that “will help to smooth the translational pathway for all those UK workers engaged in regenerative medicine”.

Meanwhile, the US Alliance for Regenerative Medicine (ARM) has announced plans to merge with its European sister organisation, the Alliance for Advanced Therapies (AAT) to create a single global entity operating ‘on behalf of the advanced therapies and regenerative medicine sector’ including cell therapy, gene therapy and tissue engineering. ARM promotes ‘legislative, regulatory and reimbursement initiatives’ to support regenerative medicine.

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