Final training module issued for ICH guideline E2B(R3)
ICH has published the final training module, “Implementation Guide for Electronic Transmission of Individual Case Safety Reports, Module III” for Guideline E2B(R3), one of several related guidelines on Clinical Safety Data Management.
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.
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.
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.