Template - PSUR Assessment Report (March 2017, correction February 2024)

The PLM Portal eAF and PMS teams are pleased to announce that the updated Frequently Asked Questions (FAQs) on eAF and PMS and Questions and Answers (Q/A) Joint eAF and PMS are now available here.

The PLM Portal eAF and PMS teams are pleased to announce that the updated Frequently Asked Questions (FAQs) on eAF and PMS and Questions and Answers (Q/A) Joint eAF and PMS are now available here.

The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.

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