by Admin | Mar 16, 2026 | Inspections & Compliance
MHRA’s December 2025 Class 4 Medicines Defect Notification for certain amitriptyline tablets says the patient information leaflet contained out-of-date safety information, including missing warnings on serotonin syndrome and dry eye. The notice also states that the...
by Admin | Mar 16, 2026 | Inspections & Compliance
MHRA’s December 2025 defect notification for certain amitriptyline tablets says the patient information leaflet did not contain all required safety information and that the errors were identified following an MHRA Good Pharmacovigilance Practice inspection and further...
by Admin | Mar 16, 2026 | Inspections & Compliance
EMA says it provides EudraVigilance training to support stakeholders in meeting their pharmacovigilance obligations and to ensure users understand system functions and submit high-quality data. EMA also states that at least one user per organisation should be trained...
by Admin | Mar 16, 2026 | Inspections & Compliance
MHRA says that amendments to the EU Commission Implementing Regulation 520/2012 took effect on 12 February 2026 and, although the UK operates an independent regulatory framework, the changes still have practical implications for some UK-authorised medicines,...
by Admin | Mar 14, 2026 | Inspections & Compliance
EMA’s EudraVigilance ecosystem is often discussed in technical terms — electronic reporting, ICSR formats, EVWEB access, registration — but there is an equally important compliance message embedded in how the system is managed. EMA says it offers training to support...
by Admin | Mar 14, 2026 | Inspections & Compliance
The UK’s updated clinical-trial framework is moving from preparation to implementation, and that makes safety-event reporting discipline more important than ever. MHRA guidance on the collection, verification, and reporting of safety events in clinical trials explains...
