Chairperson: Priscilla…
Chairperson: Priscilla Schoondermark
Training presentations on Active…
Training presentations on Active Substance Master File (ASMF) work sharing procedure:
Mock Example Developed to Illustrate Quality Modules of ICH M4Q(R2) Common Technical Document
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…
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
Harmonised ICH M15 Guideline, General Principles for Model-informed Drug Development, Adopted
The ICH M15 Guideline, General Principles for Model-informed Drug Development, has been adopted and will now enter the implementation phase.
CMDH PRESS RELEASES 2026
Report from the meeting held on 27-28 January 2026
Final ICH51 Management Committee and Assembly Meeting Minutes Now Available
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:…
Meeting 27-29 January 2026: Agenda
Updated Technical Documents Issued by ICH Expert Working Groups for Three Guidelines
Three ICH Expert Working Groups have issued an updated document package, a mapping document and training materials, respectively, associated with three technical Guidelines: E2B(R3) - Individual Case Safety Report Specification; M4Q(R2) - The Common Technical Document; and E6(R3) - Good Clinical Practice.