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

LactuloseDate of publication: 08/08/2025

Piperacillin/tazobactamDate of publication: 08/08/2025

WarfarinDate of publication: 08/08/2025

LevosimendanDate of publication: 08/08/2025

LinezolidDate 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.

RESPONSE TO NITROSAMINE IMPURITIES A report is available outlining the the European medicines regulatory network’s response to nitrosamine impurities in human medicines.  The report summarises the scientific and regulatory milestones since the discovery of nitrosamine impurities in 2018. These impurities were detected in a group of cardiovascular medicines known as 'sartans' and later also in [...]