Consultation on the regulation of gene therapy medicinal products

15th May 2026

Summary:
The consultation sets out proposals to update and refine the regulatory framework for gene therapy medicinal products in the UK, reflecting rapid scientific advances and increasing use of these innovative treatments. It explores how current legislation applies to gene therapies, identifies areas where clarification or change may be needed, and invites feedback from stakeholders across the life sciences sector. The aim is to ensure that regulation supports innovation while maintaining robust safety, quality and efficacy standards for patients. The consultation also considers alignment with international approaches and how the UK can remain an attractive environment for development and clinical research in this field.

Link: https://www.gov.uk/government/consultations/consultation-on-the-regulation-of-gene-therapy-medicinal-products

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