Oct 16, 2025
The new version of EUDAMED 2.18.0 has been deployed.
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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