Decentralised Manufacture: The designation step

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a formal guidance framework under Statutory Instrument (SI) 2025 No. 87 to regulate Decentralised Manufacture (DM). This framework specifically addresses Point of Care (POC) and Modular Manufacture (MM), ensuring these methods are used only when traditional centralized manufacturing is not viable. The guidance requires organizations to obtain a 'DM designation' early in the development process to provide regulatory clarity and ensure patient safety. To qualify for POC designation, applicants must prove that manufacture near the patient is essential due to short product shelf-life, stability issues, or specific administration requirements. For MM, justifications must focus on exceptional public health needs or significant clinical advantages. The MHRA emphasizes that designation will not be granted for reasons of cost-saving or logistical convenience. Required actions for companies include submitting a formal justification and a Decentralised Manufacturing Master File (DMMF) to the MHRA prior to applying for Clinical Trial Authorisations or Marketing Authorisations. The MHRA reviews these applications within 60 to 90 days. If successful, the applicant receives a unique designation number that must be included in all future regulatory submissions. This process ensures that innovative manufacturing methods are appropriately integrated into the UK healthcare system while maintaining rigorous oversight.