EMA Releases ICH M11: A New Era for Clinical Study Protocols
The EMA has published the ICH M11 guideline, introducing a harmonised, structured and digital-ready template for clinical study protocols — a major step forward for global clinical research.
🔹 Quality by Design built-in: ICH M11 reinforces QbD at protocol level, fully aligned with the evolution of ICH GCP E6(R3) and its focus on critical-to-quality factors and risk-proportionate trial design.
🔹 Digital & interoperable: Standardised content enables smoother electronic exchange and more efficient regulatory review.
🔹 Strategic for Europe 🇪🇺: ICH M11 complements the EU Clinical Trials Regulation (CTR) and ACT EU initiatives, including CTR pilot phases, all aiming to make Europe more competitive and attractive for clinical research.
From protocol design to regulatory efficiency, this is a clear signal: quality, harmonisation and competitiveness go hand in hand.