Decentralised Manufacture: UK Guideline of Good Pharmacovigilance Practices

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance for Marketing Authorisation Holders (MAHs) regarding pharmacovigilance (PV) for Point of Care (POC) and Modular Manufacture (MM) medicines. Unlike traditional centralized production, these products are manufactured in decentralized settings near patients, which introduces significant manufacturing variability and safety challenges. The regulatory framework is governed by the Human Medicines Regulations (HMR) 2012 and Good Pharmacovigilance Practice (GVP) modules. The main issues identified are the need for rigorous site-level traceability and the potential for site-specific safety signals. Required actions include establishing robust batch traceability systems where identifiers are provided to healthcare professionals and patients. MAHs must update Risk Management Plans (RMPs) to reflect decentralized infrastructure and ensure that the 'Day 0' for reporting adverse drug reactions (ADRs) begins when information reaches the manufacturing Control Site. Serious ADRs must be reported within 15 days and non-serious within 90 days. Furthermore, Periodic Safety Update Reports (PSURs) must stratify patient exposure data by manufacturing site to detect localized risks. The UK Qualified Person for Pharmacovigilance (QPPV) is required to maintain oversight of these manufacturing links. For products under the Early Access to Medicines Scheme (EAMS) or Specials, companies must maintain detailed supply and reaction records for at least five years to ensure comprehensive safety monitoring.