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EMA ANNUAL REPORT 2024

EMA’s annual report 2024 published on June 10th, gives insights into the Agency’s strategic priorities and contributions to public and animal health in the European Union (EU).

The digital report outlines the most important highlights regarding the evaluation and monitoring of human and veterinary medicines and a selection of key figures

News & Trends

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Recentes

  • FDA Biosimilar Development – Q&A Guidance: Q&As on Biosimilar Development and the BPCI Act
  • NDSG workplan 2026-2028 : Data and AI in medicines regulation
  • New guidance on the conduct of clinical trials during public health emergencies
  • Nova lei regula ensaios clínicos de medicamentos para uso humano em Portugal
  • FDA draft guidance :“New Clinical Investigation Exclusivity: 3-Year Exclusivity for Drug Products – Questions and Answers.”
  • webinar INTELIGÊNCIA ARTIFICIAL NA INDÚSTRIA FARMACÊUTICA :IA EM CONTEXTO GxP (Annex 11, 22, EU AI Act , GAMP®)
  • GESTÃO da DISPONIBILIDADE do MEDICAMENTO: “Formação muito útil !
  • IMDRF Playbook for Medical Device Regulatory Reliance Programs

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