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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

  • Advice on ‘end-of-year’ submission dates for type I variations in 2026
  • EMA UPDATE : COMPLIANCE with EU GMP Annex 22 and Artificial Intelligence Standards
  • FDA GUIDANCE DOCUMENT – E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification;
  • The Council of the European Union has formally adopted the Pharmaceutical Package
  • Sponsor Guidance: New Safety Module on the Annual Safety Report
  • A Formiventos está novamente no ranking das Top 5% melhores PME de Portugal
  • Electronic Submission Template for Premarket Approval Applications (PMAs)
  • MDSAP Technical Review and Recognition Decision Procedure

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info@formiventos.com

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