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BioWorld - Wednesday, May 20, 2026
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Home » MHRA sets out proposal to redefine gene therapies
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MHRA sets out proposal to redefine gene therapies

May 12, 2026
By Nuala Moran
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The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on changes it is proposing to the legal definition of gene therapies, to reflect the advances in technology and manufacturing over the two decades since the current legislation was drawn up. The aim is to correct the mismatch between regulatory terminology and modern science, which MHRA says “can lead to uncertainty” over how a product is classified and to “inconsistent oversight and potential barriers for developers."
BioWorld Gene therapy Europe MHRA

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