Clinical Trials Highlights: July 2026

29th July 2026

Summary: This edition highlights the importance of timely publication of clinical trial results through CTIS, with regulators introducing new measures to improve compliance and transparency. It also covers the publication of the ACT EU Q2 2026 monitoring report, the release of ICH E6(R3) Annex 2, and an EMA workshop report on the use of external controls in regulatory decision making. Sponsors are reminded to prepare for the new CTIS safety module, launching on 28th September 2026, which will introduce updated processes for Annual Safety Reports, alongside improvements to CTIS functionality, training resources and access to the training environment. The newsletter also includes updates on the COMBINE Phase 2 pilot, upcoming CTIS training, a women's health workshop, and a survey on EU-Innovation Network guidance.

Link: https://ec.europa.eu/newsroom/ema/newsletter-archives/78015

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