The Medicines and Healthcare products Regulatory Agency (MHRA) has announced new regulations which allow personalised medicines to be prepared in small or individual batches.
The legislation, known as The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, makes the UK the first country in the world to introduce a dedicated legal framework for medicines made at the point of care.
The move aims to strengthen the UK’s leadership in safe, decentralised manufacturing, boost research and trials, and improve patient access to cutting-edge treatments.
This change demonstrates how the MHRA is leading in the UK’s commitment to being at the forefront of modern healthcare, innovation and regulation. The MHRA has recognised that some practices are better with more flexibility, and that in a technology enabled world which allows better training, information and communication, flexibility can be enabled without compromising safety.
Matthew Durdy, Chief Executive at the CGT Catapult
“This is not just a step forward for innovative medicines such as cell and gene therapies, it is a step towards enabling truly personalised medicine. We applaud this change introduced by the MHRA and look forward to a future where more patients can receive therapeutics tailored to their needs, quickly, cost-effectively and sustainably.
Read more about this announcement on the Government website.