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Dezember 20025: key takeaways on the critical medicines act, the pharma package and more

 

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795
– General Approach

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Recentes

  • EU MDR Update: New Harmonised Standards for Medical Devices
  • Clinical evidence for orphan in vitro diagnostic medical devices
  • Questions and answers for marketing authorisation holders/applicants referral on nitrosamine impurities in human medicinal products
  • TEAM NB Code of Conduct for Notified Bodies vs 5.3
  • GIRP POSITION PAPER: Revision of the EU Guidelines on Good Distribution Practice for Medicinal Products for Human Use
  • New guidance document MDCG 2026-6 on Guidance on clinical evidence for orphan IVDs
  • AI in pharmacovigilance – EMA update
  • Formação ESTUDOS DE ESTABILIDADE . New ICH Q1 Guideline changes: ” Formação bastante abragente e de alto valor técnico”

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