The ICH Assembly met in Rio de Janeiro on 2-3 June 2026 and adopted ICH E6(R3) Annex 2 at Step 4. Annex 2 supplements the E6(R3) Principles and Annex 1 with Good Clinical Practice considerations for clinical trials that incorporate decentralised elements, pragmatic approaches, and real-world data. With the Principles and Annex 1 already in effect under EMA from 23 July 2025, the new Annex 2 closes the gap for hybrid and registry-based study designs.
Annex 2 spells out how sponsors and investigators should apply GCP when significant trial activity moves outside a traditional clinic - telemedicine visits, direct-to-participant shipment of investigational products, electronic data capture from wearables and mobile apps, and the use of routinely collected health data. It sits alongside two other recent ICH finalisations: M14, on the design and analysis of pharmacoepidemiological studies that use real-world data for post-marketing safety, reached Step 4 on 4 September 2025; and M11 (CeSHarP), the harmonised electronic clinical-trial protocol template, was adopted at the Singapore Assembly in November 2025.
Two draft guidelines with broader manufacturing reach remain in review. The consolidated Q1 stability draft reached Step 2b on 11 April 2025 and would replace ICH Q1A through Q1F and Q5C in a single document; the EMA consultation closed on 30 July 2025 and the FDA window closed on 25 August 2025. Q3E, the first ICH guideline dedicated to extractables and leachables, was endorsed at Step 2 on 1 August 2025; the UK MHRA national consultation closed on 19 January 2026. The Q1 and Q3E expert working groups are now consolidating comments before drafting Step 4 text. Neither has an implementation date.
For clinical operations, Annex 2 turns regulator-by-regulator decentralised-trial guidance into a single harmonised baseline. For stability and packaging teams, the Q1 and Q3E timelines are the regulatory milestones to track next - both will land on top of existing programmes rather than replace them on a fixed date, so the practical question is how Step 4 text differs from the Step 2 drafts that companies are already gap-assessing against. Spectrane has tracked the slower-moving Q-series rollout in ICH Q14 implementation tracker - 30 months in and the cross-regulator picture in Comparing FDA, EMA, and PMDA on chemometric model lifecycle.