Últimas noticias
Training Module Issued for ICH Guideline M15 on Model-informed Drug Development
ICH has issued an overview training module for harmonised Guideline ICH M15: General Principles for Model-Informed Drug Development. The M15 Guideline was adopted in January of this year.
Summary of CMDh activities 2025 …
Summary of CMDh activities 2025
CMDh Multi-annual Workplan to 2028…
CMDh Multi-annual Workplan to 2028 (March 2026)
Ramipril/indapamideDate of…
Ramipril/indapamideDate of publication: 07/04/2026
Updated and Expanded ICH Q9(R1) Quality Risk Management Briefing Pack Now Available
ICH has published an updated and expanded Q9(R1) Quality Risk Management Briefing Pack to support the implementation of a systematic approach to quality risk management in pharmaceutical development, manufacturing and distribution.
Member: Katrine Damkjær…
Member: Katrine Damkjær MadsenAlternate: Therese Langkjær Danish Medicines AgencyAxel Heides Gade 1DK-2300 COPENHAGEN
Benzocaine / TyrothricinEnd of…
Benzocaine / TyrothricinEnd of procedure: 28/02/2025Date of publication: 04/03/2026
CMDh Multi-Annual Workplan to 2025…
CMDh Multi-Annual Workplan to 2025 - Summary Report (February 2026)
Member: Maija CirkinaAlternate:…
Member: Maija CirkinaAlternate: Iveta Eglite State Agency of MedicinesJersikas iela 15LV-1003 RIGA
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.
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 [...]
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 [...]