Últimas noticias
Key Outcomes of Biannual ICH Assembly Meeting
The Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) met in person on 2–3 June 2026 in Rio de Janeiro, Brazil for its biannual meeting. The ICH [...]
Vaccin rabique Pasteur / Verorab…
Vaccin rabique Pasteur / Verorab (rabies virus inactivated (Wistar rabies PM/W138 1503-3M strain))End of procedure: 10/04/2026Date of publication: 27/05/2026
Efluelda Tetra (quadrivalent…
Efluelda Tetra (quadrivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain)End of procedure: 14/04/2026Date of publication: 27/05/2026
Rapibloc / Landiolol Hydrochloride…
Rapibloc / Landiolol Hydrochloride Orpha-Devel (landiolol hydrochloride)End of procedure: 09/04/2026Date of publication: 27/05/2026
ICH M11 Expert Working Group issues final overview presentation
The ICH M11 Expert Working Group has issued a final overview presentation (at Step 4 of the ICH harmonisation process) for ICH M11: The Clinical electronic Structured Harmonised Protocol (CeSHarP), a guideline adopted in November [...]
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.