The ICH Secretariat is pleased to announce the publication of ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management” Module 8 Training Material.
Added in February 26 February NEW - 23-25 January 2024 CMDh minutes 20 February NEW - 20-21 February 2024 CMDh agenda
Summary of CMDh activities 2023
Added in March 11 March PSUR Summary Assessment Report for Yimmugo
The ICH Secretariat is pleased to announce the publication of ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” Training Material.
Member: Örn Gudmundsson Alternate: Ragnhildur Heidarsdottir Iceland Medicines Agency Vinlandsleid 14 113 Reykjavik Iceland
The ICH Q3C(R9) “Guideline for Residual Solvents” was revised using the ICH Minor Revision Procedure and reached Step 4 of the ICH Process on 24 January 2024.
The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of individual Case Safety Reports” has reached Step 2 of the ICH process on 5 February 2024.
This page lists the current members and alternates of the Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh). For more information, see European expert declaration of interests and professional qualifications. For contact details, please refer to the affiliated organisations of individual committee members.
The electronic Application Form (eAF) Product Team would greatly appreciate to receive your feedback on your current experience in terms of time spent in filling in the interactive pdf electronic Application Form (eAF) for Variations for Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs), and Initial Marketing Authorisation.