EMA SME Highlights Issue 69: New Support for Innovation, AI and Clinical Developm

19th June 2026

Summary: The European Medicines Agency's latest SME Highlights newsletter showcases a range of initiatives designed to help smaller companies navigate the EU regulatory landscape. Key updates include the announcement of SME Info Day 2026, publication of a report marking 20 years of the SME Regulation, enhancements to the PRIME scheme following a successful pilot, and a new scientific advice pilot focused on model-informed drug development. The newsletter also highlights support for orphan and breakthrough medical devices, publication of the 2025 AI Observatory report, updates to the ACT EU clinical trials workplan, new CTIS guidance for sponsors, and expanded use of real-world data in medicines regulation. Several upcoming workshops and consultations are also featured, reflecting EMA’s continued focus on innovation, regulatory science and stakeholder engagement.

Link: https://ec.europa.eu/newsroom/ema/newsletter-archives/76691

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