DDReg Pharma- Consulting in regulatory affairs and drug safety

  2026 is shaping up to be a transformative year for pharmacovigilance in the European Union and at the heart of this change is a comprehensive overhaul of the European Medicines Agency’s (EMA) Good Pharmacovigilance Practices (GVP) framework. This isn’t just regulatory housekeeping; it’s a smart modernisation of how drug safety is monitored, analysed, and communicated across the EU. What’s Changing and Why It Matters The EMA has signalled that almost all GVP modules are scheduled for revision in 2026 , spanning core areas such as signal management, risk management plans, inspections, individual case safety reports (ICSRs), and post-authorisation safety studies. These updates are part of a wider push to ensure pharmacovigilance keeps pace with scientific, technological, and data-driven advances in medicine. Key trends emerging from the GVP update schedule include: 🔹 Modernised Signal Detection and Management- Modules such as GVP IX are being updated to reflect more integrate...