European Commission and HMA published the materials from the ACT EU webinar (8 April) presenting the new draft guidance on the conduct of clinical trials during public health emergencies (PHEs) —
Now open for public consultation until 30 April 2026.
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- FDA eMDR – Electronic Medical Device Reporting
- ACT EU Draft Guidance on Clinical Trials During Public Health Emergencies
- 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