Recentes

• European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
• European medicines agencies network strategy to 2028
• MDCG 2024-11 – Guidance on qualification of in vitro diagnostic medical devices (October 2024)
• Study supporting the monitoring of the availability of medical devices on the EU market
• Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams
• Iniciativa para melhorar a eficiência na aprovação de novos medicamentos na UE
• Consulta pública a decorrer para Projeto de Regulamento de Execução sobre consultas científicas conjuntas de medicamentos
• EUDAMED user guide Guidelines on Data Exchange with EUDAMED