The Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) met in person on 2–3 June 2026 in Rio de Janeiro, Brazil, for its biannual meeting. The meeting was opened by ICH Assembly Chair Dr. Gabriela Zenhäusern (Swissmedic, Switzerland) and Vice-Chair Mr. Jeffrey Skene (Health Canada, Canada).
ICH is delighted to welcome DRAP, Pakistan, and Medsafe, New Zealand, as new ICH Observers, bringing ICH to a total of 25 Members and 43 Observers.
ICH Strategic Vision & Roadmap
The Assembly discussed ICH’s future direction and approved a proposed Strategic Vision outlining ICH’s vision, mission and role in advancing public health through harmonised guidelines. The Assembly also received an update on the development of a multi-year Strategic Roadmap for ICH Guidelines. The Strategic Roadmap will include a revised process for selecting new topics for ICH Guideline development.
ICH Technology Task Force
The Assembly was updated on the work of the ICH Technology Task Force, which was established in 2025 to develop recommendations defining the functional and technical requirements for a digital platform for collaboration to support the harmonised development and consistent implementation of ICH Guidelines. The Report of the ICH Technology Task Force was approved for publication on the ICH website.
Progress on ICH guideline development and important revisions
Final Guideline adopted at Step 4
The ICH E6(R3) Guideline for Good Clinical Practice (GCP), Annex 2 was adopted as Final by the Assembly (Step 4 of the ICH harmonisation process) and has now entered the implementation phase.
Annex 2 of the Guideline includes additional considerations on how GCP principles may be applied across a variety of trial designs and data sources, where applicable. This will include aspects such as decentralised elements, pragmatic elements and real-world data (RWD) sources.
The next ICH Assembly meeting is scheduled to take place in Prague, Czech Republic, on 17 and 18 November 2026.
Further information can be found in the ICH press release: ICH website
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