Regulatory advice service for regenerative medicine

Last updated on 19 Mar 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Office is the portal for all regulatory queries concerning regenerative medicines. 

A “one stop shop” service provides a single point of access from the four regulators in the field, the Human Tissue Authority (HTA), the Human Fertilisation and Embryology Authority (HFEA), Health Research Authority (HRA) and the MHRA, who will  provide a co-ordinated single response service for free regulatory advice.

Any query relating to the regulation of regenerative medicines, including Advanced Therapeutic Medicinal Products (ATMPs) can be submitted to the MHRA’s Innovation Office and will be answered by the relevant experts from the four regulatory bodies.

Individuals or companies who have regulatory questions concerning regenerative medicines and who are unsure which agency to direct their inquiry to, or have a query that impacts several regulators, should use the Innovation Office advice form.

Working in partnership

We work closely with others and will continue to engage with those involved in regenerative medicine, including researchers, the British Society for Gene and Stem Cell Therapy, and the Cell Therapy Catapult to help clarify the regulatory requirements that apply.

The HRA recently held a regenerative medicine event hosted by the Cell Therapy Catapult to look at changes and discuss issues with the sector, regulators and representative bodies. Additionally in 2012, the MHRA hosted an event on the regulation of regenerative medicine.

As set out in the Government Response to the House of Lords Inquiry a Regenerative Medicine Expert Group (RMEG) is being established to develop an NHS regenerative medicine delivery readiness strategy and action plan. This group will build on existing initiatives so that the NHS is fully prepared to deliver these innovative treatments. The group will be supported by the Department of Health; members will be drawn from a number of groups and organisations, including the HRA. The remit of the Regenerative Medicine Expert Group will include a role to monitor the effect of regulation on the development of regenerative medicines in the UK.

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