Últimas noticias
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 [...]
Presentation and Training Materials Now Available for Draft Guideline on Patient Preference Studies
As a follow-up to the November 2025 endorsement and publication of the ICH E22 draft Guideline on General Considerations for Patient Preference Studies, the E22 Expert Working Group has issued an informational presentation and training [...]
Marta Marcelino INFARMEDParque de…
Marta Marcelino INFARMEDParque de Saúde de LisboaAvenida do Brasil, n° 53PT-1700 LISBOA
Nebivolol hydrochloride /…
Nebivolol hydrochloride / amlodipine besilateDate of publication: 17/12/2025
RifabutinEnd of procedure:…
RifabutinEnd of procedure: 20/08/2025Date of publication: 17/12/2025
Levothyroxine / LiothyronineEnd of…
Levothyroxine / LiothyronineEnd of procedure: 30/07/2025Date of publication: 17/12/2025
CGTDG – Recommendations with regard to future Advanced Therapy Medicinal Products (ATMPs) Related Guidelines
CGTDG - Recommendations with regard to future Advanced Therapy Medicinal Products (ATMPs) Related Guidelines The Cell and Gene Therapy Discussion Group (CGTDG), which was established in May 2023, has provided as an output of its [...]