MC EXCLUSIVE: MHRA on a mission to redefine UK gene therapy

By Emily Letton | Published: 13-May-2026
Regulatory Cell & Gene Therapy

The UK's medicines regulator is seeking industry input on a landmark overhaul of gene therapy medicinal product definitions — the first substantive update in more than two decades — as synthetic mRNA and CRISPR-based technologies outpace the legal framework designed to govern them

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For the first time in more than 20 years, the MHRA is proposing to modernise the legal definitions underpinning gene therapy medicinal products (GTMPs) in the UK. In an exclusive interview with Manufacturing Chemist, Julian Beach, Interim Executive Director of Healthcare Quality and Access, set out the rationale behind a public consultation now open to manufacturers, academics, clinicians and patient groups. 

The consultation proposes revisions to the Human Medicines Regulations 2012 (HMRs), which trace their GTMP definitions back to a European regulatory framework from 2001. In the intervening years, science has moved decisively beyond them. "We need to ensure that the regulation enables science, rather than hinders it," Beach said.

Why the current definition no longer fits

Two categories of technology have most acutely exposed the definition's limits.

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The UK regulator is seeking industry feedback on proposed updates to the legal classification of GTMPs, as advances in synthetic biology and gene editing outpace definitions set more than a decade ago

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