A ‘one-stop shop’ to provide regulatory advice on regenerative medicines has been launched in the UK.
The service will, for the first time, provide a single point of access to the four regulatory bodies that work in the sector – the Human Tissue Authority, the Human Fertilisation and Embryology Authority, Health Research Authority and the Medicines and Healthcare products Regulatory Agency. It will help organisations “to quickly and easily navigate the different regulators and allow them to get the right advice more quickly” and will also provide a single response from the regulators.
Any query relating to the regulation of regenerative medicines can now be submitted to the MHRA’s Innovation Office and will be answered by experts from the relevant regulatory body. The advice is also available to those developing advanced therapeutic medicinal products (ATMPs).
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”. He argued that 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”.
Chris Mason, professor of regenerative medicine at University College London, said the initiative is “a major breakthrough” which “will accelerate medical progress across all the great scientific breakthroughs made by our stem cell researchers and clinicians”. He added that this joined-up approach will enable UK scientists and companies to “more rapidly translate ground-breaking research into game-changing therapies and cures”.
