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Medicamentos biossimilares na UE

The European Medicines Agency (EMA) and the European Commission have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU). A biosimilar is biological medicine that is highly similar in all essential aspects to a ‘reference’ biological medicine already authorised.

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Recentes

  • FDA Guidance for Drug Development
  • Study supporting the monitoring of the availability of medical devices on the EU market. 2 July 2026
  • IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)
  • GMP CANÁBIS 2026 : “Formação conduzida com profundo domínio teórico e prático “
  • MHRA Open consultation Draft rare disease therapies regulatory framework
  • EU Delegated Acts on Well-Established Technologies (WET) under the MDR
  • CLINICAL TRIALS: EMA CTIS Sponsor Handbook
  • Update to EU GMP Guidelines – Revised Annex 19 on Reference and Retention Samples

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