A cross-agency team of Quality and Clinical Trial assessors, Safety and Surveillance assessors, and Good Manufacturing Practice (GMP), Pharmacovigilance (PV) and Good Clinical Practice (GCP) inspectors at the UK Medicines & Healthcare products Regulatory Agency (MHRA) has been working closely with scientists from the MHRA Science Campus to develop and promote guidance for the manufacture of personalised medicines.
New legislation on decentralised manufacturing (DM), which is the term used to cover both point of care and modular manufacturing, came into force in July 2025. MHRA leaders are now raising awareness of the requirements and guidance available to support the possibilities for individualised patient care.
In a recent blog post discussing emerging considerations, the MHRA team said, ‘Given the early stage of DM, it is expected that this new sector will change considerably over the next few years. As experience is gained, the guidance texts will be reviewed and revised.’
Detailed information, including video recordings, is available on a dedicated Decentralised manufacturing hub webpage. Key aspects in the new regulatory framework include a designation step and justification of clinical benefit.
DM processes allow medicinal products to be made close to, or at the location of, the patient for the administration of medical products. DM medicines encompass a wide and diverse array of different manufacturing techniques, and the products manufactured are typically innovative, such as those using patient blood, cells or tissues, or that have a very short shelf-life of minutes rather than years.
The MHRA has been leading international collaborative work on this topic, with the aim of developing harmonised regulatory guidance documents. To this end, a workshop was held in December 2024 with the International Coalition of Medicines Regulatory Authorities (ICMRA). A summary report of the ICMRA workshop is available on its website.
The implementation of DM frameworks is also currently being considered as part of the new EU pharmaceutical legislation, and as part of the US Food and Drug Administration’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative.
