Guidance for ASMF holders and MA holders on Providing Regulatory Information in Electronic Format
News & Trends
Procurar
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