From the regulatory newsfeed of the Medicines and Healthcare products Regulatory Agency (MHRA), Arex Advisor has selected the most important regulatory updates from the past month.
MHRA consults on updating regulation of gene therapies
11 May 2026
The MHRA has launched a consultation on the regulation of gene therapy medicinal products, reflecting advances that increasingly challenge current UK definitions established in 2007. The review aims to ensure the regulatory framework keeps pace with innovations such as synthetic genetic material, genome editing, and engineered cells and tissues, helping clarify how emerging therapies should be classified and regulated. Read more
Expert calls for flexible regulation to support life sciences innovation
18 May 2026
MHRA guest blog highlights the need for regulatory frameworks must evolve alongside rapid advances in life sciences, to ensure innovation can reach patients efficiently and safely. The article focuses on the importance of flexibility, proportionality, and collaboration between regulators and developers, emphasising that effective partnership is key to unlocking the full potential of emerging technologies. Read more
MHRA consults on new framework for rare disease therapies
21 May 2026
The MHRA has launched a public consultation on a proposed Rare Disease Therapies Framework aimed at accelerating development of treatments for rare conditions in the UK. The initiative proposes significant regulatory innovation and invites input from the pharmaceutical and life sciences sectors to help shape a framework designed to strengthen the UK’s position in rare disease therapy development. Read more
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