The Regulatory Advice Service for Regenerative Medicine (RASRM)

The Advice Service aims to reduce the burden of navigating and adhering to the required standards and legislation in this complex area. It supports innovation in organisations developing regenerative medicines. It also ensures that those sponsoring clinical trials, and other interested parties, can have confidence that organisations adhere to relevant regulations.

The service collects and provides cross-regulatory advice and guidance from:

• Health Research Authority (HRA)
• Human Fertilisation and Embryology Authority (HFEA)
• Human Tissue Authority (HTA)
• Medicines and Healthcare products Regulatory Agency (MHRA)
• Other specialist bodies, such as the Health & Safety Executive (HSE) and Department for Rural Affairs (Defra)

Any query relating to the regulation of regenerative medicines* (including ATMPs), from individuals or companies who are unsure which regulator to direct their inquiry to, or have a query that impacts several regulators, can seek an answer from the Advice Service.

The Advice Service is accessible at any time via an online form, hosted on the MHRA’s Innovation Office. When submitting your enquiry, you’ll need to tick the box ‘Advanced Therapy Medicinal Product (including joint advice from HTA, HFEA, HRA and MHRA)’ in the ‘Technology’ section. Queries will be answered within 20 days. Those with an HTA related enquiry about a tissue or cell based therapy can also contact the HTA directly.

Notes

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. More information about ATMPs can be found on our ATMP definitions page.