MHRA proposes modernisation of gene therapy products classification

By 2026-05-11T12:36:00

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UK medicines agency calls for a more technologically neutral approach to the current legal definitions of gene therapy medicinal products.

The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking feedback on its proposal to update to the definition of gene therapy medicinal products (GTMPs).

The revisions are intended to align with current advances in science and manufacturing. The resulting modernised, future-proofed framework is set to increase clarify for developers of these products.

The range of gene therapy types available has expanded since the definition of GTMPs was first developed in 2007, meaning some of these products do not fit neatly into the categories defined in the existing

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