The UK’s MHRA opened a consultation proposing updates to the legal definition of gene therapies, aiming to reflect technological and manufacturing advances over the past two decades. The move targets how gene therapy is categorized under UK rules, which can affect compliance pathways and regulatory expectations for developers. The consultation comes as gene therapy platforms diversify beyond classic viral vector approaches, including newer delivery methods, manufacturing strategies and clinical-grade analytics. For biotech, the consultation signals that developers may need to reassess how their product classifications map to evolving MHRA definitions and oversight models.