The EU health policy Pharmaceutical Reform . Awareness session for SMEs EMA

Recentes

• EMA’s ePI Roadmap
• Sponsor Frequently Asked Questions Clinical Trial Information System (CTIS) Frequently Asked Questions (FAQs) on the Sponsor’s workspace
• The new CTIS Sponsor Handbook (v6.2, March 2026)
• New revision of the Q&A document on art. 10(a) interruption of supply published
• IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)
• New Harmonised Standards under MDR – April 2026
• EMA/CHMP: Updated Guideline on Active Substances published
• Data Quality Framework for EU medicines regulation: application to Real-World Data