UK Launches Regenerative Medicines Regulatory Advice Service

UK Launches Regenerative Medicines Regulatory Advice ServiceA new ‘one-stop shop’ was launched in the UK yesterday, to provide regulatory advice for life science organisations working on regenerative medicines.

The service, which will sit within the MHRA’s Innovation Office, will provide cross-regulatory advice from the regulatory bodies that work within regenerative medicines: the Human Tissue Authority; Health Research Authority; Human Fertilisation and Embryology Authority; and Medicines and Healthcare products Regulatory Agency.

The new service will help organisations “quickly and easily navigate the different regulators and allow them to get the right advice more quickly.” It will also unify the response from the four regulatory bodies, by providing a single response to enquiries.

Any queries regarding the regulation of regenerative medicines, or related to the development of advanced therapeutic medicinal products, can be submitted to the MHRA’s Innovation Office and it will be answered by experts from the relevant regulatory body.

George Freeman, the UK’s life sciences minister, commented that he wants 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 added that the new regulatory advice service “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, also commented that 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.”

Mason noted that the joined-up approach from the new service will enable UK scientists and businesses to “more rapidly translate ground-breaking research into game-changing therapies and cures,” strengthening “the UK as a world leader in cell and gene therapies.”

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