BIA response to MHRA consultation on gene therapy medicinal products

The BIA has responded to the MHRA’s consultation on proposed updates to the definition of gene therapy medicinal products. The proposed updates aim to modernise the GTMP definitions to reflect current scientific practice due to advances in gene therapies since the original definitions were developed in 2007. The MHRA’s proposals are largely aligned with the EU’s proposed amendments, with a few differences which are outlined in the consultation document.

The BIA welcomes the MHRA’s proposals, which provide greater clarity for developers and will help to maintain the UK’s position as a supportive environment for advanced therapy development. In our response, we:

• Welcomed the MHRA’s proposals to align with the key revisions in the EU’s updated GTMP definition, with a few differences which aim to provide greater alignment and consistency.
• Highlighted areas where the guidance would benefit from further clarity, including by providing illustrative examples. 
• Set out our perspective on the impacts of the changes for developers and the wider life sciences sector involved in the supply chain for advanced therapies.