The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on updating the legal definition of gene therapy medicinal products (GTMPs) in the UK.
The consultation opens today, 11 May 2026 and runs until 22 June 2026.
The decision, made jointly with the Department of Health in Northern Ireland, will aim to ensure that UK regulation keeps pace with advances in gene therapy, synthetic biology and gene-editing technologies.
The proposed changes centre on how a product is classified as a gene therapy — shifting the basis of definition towards the mechanism of action rather than the biological origin.
The regulatory body said that the current definitions, established more than a decade ago, were designed for a different scientific landscape.
Since then, advances in synthetic biology, gene editing and manufacturing technologies have raised questions about whether the existing regulatory language adequately covers modern approaches.
Crucially, the MHRA has been clear that the proposed amendments would not alter the approval pathway for gene therapies, change the regulatory status of already-licensed products, or affect existing safety, quality, or efficacy standards.
The intent, it said in its statement, is definitional clarity rather than regulatory overhaul.
The five areas under consultation are the following:
- removing the requirement for GTMPs to be biological in origin
- clarifying the conditions under which synthetic or recombinant nucleic acids bring a product into scope
- ensuring that sequence-specific genome editing technologies are unambiguously regulated as GTMPs regardless of substance type
- maintaining the existing exclusion of infectious disease vaccines from GTMP definitions
- proposing corresponding amendments to the Human Medicines Regulations 2012.
Jon Beaman, MHRA Deputy Director of Innovative Medicines, said the proposal reflects the pace of scientific progress and is designed to give developers and clinicians greater regulatory certainty while keeping patient safety central.
Our teams have carefully designed these updates to ensure that patient safety remains at the centre of any change, while also giving developers, researchers and clinicians greater regulatory certainty, while supporting innovation across the industry.
The regulator is primarily targeting feedback from developers, manufacturers, researchers, regulatory professionals and clinical and academic experts, though responses are open to all stakeholders.
The consultation period closes on 22 June 2026.