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  • The first harmonised standard under the EU AI Act is here
  • 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

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