Recentes

• PHARMA PACKAGE : Council adopts new rules for a fairer and more competitive EU pharmaceutical sector
• HTA Regulation – Commission selects first medical devices for joint clinical assessment
• PHARMACOVIGILANCE UPDATE | FDA E2B(R3) IMPLEMENTATION GUIDE — OCTOBER 2026
• updated PIC/S PI 006-4 guideline RECOMMENDATIONS ON QUALIFICATION AND VALIDATION
• Annual report of the Pharmacovigilance Inspectors Working Group for 2025
• European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
• ACT EU workplan 2026 – 2027
• Advice on ‘end-of-year’ submission dates for type I variations in 2026