The ICH Q3E draft “Guideline for Extractables and Leachables” and supporting document has reached Step 2b of the ICH Process on 1 August 2025 and entered the Step 3 public consultation period.

GliclazideDate of publication: 08/08/2025

LoperamideDate of publication: 08/08/2025

WarfarinDate of publication: 08/08/2025

LinezolidDate of publication: 08/08/2025

Piperacillin/tazobactamDate of publication: 08/08/2025

LactuloseDate of publication: 08/08/2025

LevosimendanDate of publication: 08/08/2025

The ICH Secretariat is pleased to announce that the updated ICH E2B(R3) Q&As, the Implementation Guide, and Appendix I (G) for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) have reached Step 4 of the ICH Process.

Repevax, Adacel-Polio, Triaxis-Polio (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed combined with inactivated poliomyelitis vaccine (Tdap-IPV))End of procedure: 21/05/2025Date of publication: 01/08/2025