Joint Research Office


'One stop shop' for regulatory advice on regenerative medicine

25 November 2014

A new 'one stop shop' providing regulatory advice on regenerative medicines has been launched.

The service means that for the first time people working in the life sciences will have a single point of access to regulatory advice from the four regulatory bodies working in the sector - the Human Tissue Authority, the Human Fertilisation and Embryology Authority, Health Research Authority and the Medicines and Healthcare products Regulatory Agency (MHRA).

Life Sciences Minister George Freeman said: "I want to make it as easy as possible for our innovative life sciences sector to get the advice they need to turn their innovations into products that can benefit patients. Regenerative medicine is thriving and the new one stop shop highlights our commitment to ensure that the UK becomes the best place in the world for life sciences."

The resource will sit within the MHRA's Innovation Office, which already provides scientific and regulatory advice to companies developing innovative medicines and medical devices.

Any query relating to the regulation of regenerative medicines, including Advanced Therapeutic Medicinal Products, can be submitted to the MHRA's Innovation Office using an enquiry form and the office has committed to answering within 20 working days by relevant staff from the four regulatory bodies.

Chris Mason, Professor of Regenerative Medicine at UCL said: "This is a major breakthrough by the UK's regulatory agencies. The one stop shop for regulatory advice will accelerate medical progress across all the great scientific breakthroughs made by our stem cell researchers and clinicians.

"This joined up approach to regulation strengthens the UK as a world leader in cell and gene therapies. Streamlining access to crucial advice from the regulators will enable UK scientists, clinicians and companies to more rapidly translate ground-breaking research into game-changing therapies and cures - good news for patients, their carers and the NHS."

The term "regenerative medicine" is used to refer to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function. This includes cell therapies, tissue engineering, gene therapy and biomedical engineering techniques, as well as more traditional treatments involving pharmaceuticals, biologics and devices.