The UK’s regulatory framework for manufacturing medicines, including advanced therapy medicinal products (ATMPs), is evolving to support decentralised manufacturing (DM), encompassing Modular Manufacture (MM) and Point of Care (POC) pathways introduced in 2025. These approaches aim to enable timely access to highly personalised therapies while maintaining appropriate regulatory oversight.
This CERSI-AT paper provides practical guidance for developers considering DM in the UK. It examines key technical, operational and regulatory challenges, including maintaining product quality across sites, ensuring supply chain robustness, demonstrating process comparability, and managing distributed quality systems. The paper also outlines relevant regulatory components such as Good Manufacturing Practice requirements, the DM designation process, and the role of the Decentralised Manufacturing Master File (DMMF), alongside illustrative examples that extend beyond existing MHRA guidance.
