Procedural advice on Zero Day MR Procedures (March 2024)

Verorab (rabies virus, inactivated) End of procedure: 17/01/2024 Date of publication: 03/04/2024

Added in April 2024 3 April UPDATE - Q&A on Pharmacovigilance Legislation NEW - Procedural advice on Zero Day MR Procedures NEW - Minutes of the Meeting of a subgroup of CMDh with Interested Parties dedicated to LoSC and publication of PI updates NEW - Art. 46 PAR on Verorab (Rabies virus, inactivated) NEW - Art. 46 PAR on Triptorelin (Decapeptyl, Diphereline, [...]

Palexia and associated names (tapentadol hydrochloride) DE/W/083/pdWS/001 End of Procedure: 01/07/2014 Date of Publication: 09/10/2014 DE/W/083/pdWS/002 End of Procedure: 15/12/2014 Date of Publication: 30/01/2015 DE/W/123/pdWS/001 End of Procedure: 10/12/2019 Date of Publication: 09/03/2020 DE/W/124/pdWS/001 End of Procedure: 19/11/2019 Date of Publication: 09/03/2020 DE/W/125/pdWS/001 End of Procedure: 16/03/2020 Date of Publication: 11/05/2020

The ICH Secretariat is pleased to announce the publication of the ICH Q12 “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management Introductory Video” following the publication of the ICH Q12 Module 8 in February 2024.

EMA Explanatory Note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines

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

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