Botox (botulinum toxin type A)End…
Botox (botulinum toxin type A)End of procedure: 04/11/2023Date of publication: 27/11/2025
Press Release: ICH Assembly Meeting, Singapore, 2025
The Assembly of the International Council for Harmonisation (ICH) met in person on 18-19 November 2025 in Singapore, in parallel with meetings of 12 Working Groups and preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee (SC).
Riamet (artemether /…
Riamet (artemether / lumefantrine)UK/W/0096/pdWS/001End of procedure: 06/02/2017Date of publication: 03/04/2017SE/W/0032/pdWS/001End of procedure: 21/07/2021Date of publication: 03/05/2023SE/W/0032/pdWS/002End of procedure: 06/02/2024Date of publication: 02/05/2024SE/W/0032/pdWS/003End of procedure: 29/07/2025Date of publication: 23/10/2023SE/W/0032/pdWS/004End of procedure: 29/07/2025Date of publication: 23/10/2023
Following the launch…
Following the launch of optional use in February 2025 and the start of the recommended use in May 2025, it is now strongly recommended to use of the PLM Portal web-based eAF for all MRP/DCP and purely national variations, where possible. This is aligned with the timeline and the roadmap towards mandatory use of the PLM Portal web-based eAF for all human variations. Please note that [...]
Xalatan / Latanoprost Viatris…
Xalatan / Latanoprost Viatris (latanoprost)End of procedure: 18/09/2024Date of publication: 23/10/2025
Post-Brexit (October 2025) …
Post-Brexit (October 2025)
ICH E6(R3) Module 1 Training Now Available on the ICH Website
The ICH Secretariat is pleased to announce the publication of the following training module, now available in the ICH Training Library: Interpretation and Application of ICH E6(R3): Good Clinical Practice Guideline - Module 1: Introduction and Foundational Concepts.
The ICH E2D(R1) Guideline reaches Step 4 of the ICH Process
The ICH E2D(R1) Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” has reached Step 4 of the ICH Process on 15 September 2025 and has now entered the implementation phase at Step 5 of the ICH Process.
PAR update (December 2009)
PAR update (January 2016)
ICH Q3E Step 2 Presentation Now Available on the ICH Website
In follow up to the publication of the ICH Q3E draft “Guideline for Extractables and Leachables” in August 2025, the Q3E EWG has also prepared a Step 2 informational presentation.