Training presentations on Active Substance Master File (ASMF) work sharing procedure:

The ICH M4Q(R2) Expert Working Group has developed a mock example to illustrate the potential structure and presentation of information in the revised Modules 2.3 and 3 of the Common Technical Document – Quality.

Pneumovax and associated names (pneumococcal polysaccharide vaccine)UK/W/0078/pdWS/001End of procedure: 08/11/2014Date of publication: 30/01/2015DE/W/0080/pdWS/003End of procedure: 18/08/2022Date of publication: 25/10/2022DE/W/0080/pdWS/004End of procedure: 28/11/2025Date of publication: 10/02/2026

The ICH M15 Guideline, General Principles for Model-informed Drug Development, has been adopted and will now enter the implementation phase.

Report from the meeting held on 27-28 January 2026

EMA published release notes describing updates and resolved issues included in PLM Portal eAF version 1.2.1.5.

The minutes of the ICH Management Committee and ICH Assembly meetings held in Singapore at ICH51 have been published. These documents summarise the decisions taken and topics discussed during the face-to-face biannual meetings, which took place in November 2025.

Meeting 27-29 January 2026: Agenda

New release notes highlight bug corrections and functional improvements delivered in the January 2026 update.