The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released six guidelines to clarify expectations and support the new regulatory framework for decentralized manufacturing (DM), which takes effect on 23 July 2025.
The guidelines implementing the modular manufacturing and point of care legislation encompass several key areas: applying for DM designation, the procedure for obtaining marketing authorization for the DM, the clinical trial authorization (CTA) for DM, good pharmacovigilance practices, the application of good manufacturing practices (GMP) for DM, and labeling requirements.
MHRA is one of the few regulatory agencies in the world to have established a regulatory framework for decentralized manufacturing. In September 2024, the US Food and Drug Administration (FDA) finalized a guidance on decentralized clinical trials, but the guidance did not address decentralized manufacturing. (RELATED: FDA’s final guidance on DCTs adds clarity on HCP task log, inspection requirements, data variability, Regulatory Focus 17 September 2024)…
