Recentes

• Article 10a MDR / IVDR: Notification in Case of Interruption or Discontinuation of Supply Decision Guide Flowchart
• New Qualification & Validation Guidelines for Pharma in 2025
• ENISA Cybersecurity Maturity & Criticality Assessment of NIS2 sectors
• EMA FAQs How to submit an annual safety report and respond to related RFIs
• Questions and answers on the Critical Medicines Act
• Atualização das listas previstas no regulamento sobre o controlo de transações de medicamentos para o exterior do país (março 2025)
• Factsheet – Critical Medicines Act: Improving the availability and securing supply of critical medicines in the EU
• Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together (March 2024, Revised February 2025);