The Medicines and Healthcare products Regulatory Agency (MHRA) this week launched a UK-wide consultation on calling to update the legal definition of gene therapy medicinal products (GTMPs).
Together with the Department of Health in Northern Ireland, the MHRA is consulting, from 11 May to 22 June 2026, on updated definitions that would classify a medicinal product as a gene therapy, based on how it works.
The aim, the MHRA reported, is to future-proof the sector and ensure regulation keeps up with advances in gene therapy, synthetic biology, and gene editing technologies.
The updated definition will not alter the approval process for gene therapies, the regulatory classification of products already licences, or change any existing safety, quality, or efficacy standards, according to MHRA.
Jon Beaman, Deputy Director, Innovative Medicines, MHRA, said: “This proposal reflects how fast-paced scientific progress can be and ensures our regulatory framework remains robust, clear and fit for the future.
“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 input provided by our industry colleagues will help to shape the final approach and ensure the proposals deliver the best possible outcome for patients and the wider health sector.”
Key proposals
The proposed amendments intend to: provide more clarity for developers of gene therapy products, ensure consistent regulation across all products whether biologically or synthetically created, support innovation by giving researchers and companies a future-proof regulatory framework and maintain high standards of patient safety and regulatory oversight.
The consultation seeks (predominantly expert) views on five key proposals:
- Removing the requirement for gene therapies to be biological in origin
- Clarifying when synthetic or recombinant nucleic acids bring a product into scope
- Ensuring products involving sequence specific genome editing are clearly regulated as GTMPs, regardless of substance type
- Maintaining the exclusion of vaccines against infectious diseases from GTMP definitions
- Proposing updates to the Human Medicines Regulations 2012 to support these revised definitions
Are current definitions of gene therapies outdated?
Current definitions were established more than a decade ago and gene therapies have since substantially evolved, the MHRA reported.
The consultation comes amid advances in science and manufacturing technologies prompting consideration on whether legislative wording remains fit for use.
Featured image: Vlad Kochelaevskiy on Adobe Stock
