LevosimendanDate of publication: 08/08/2025

LactuloseDate 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 [...]

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

Instructions for RMS when preparing the PAR based on the FAR (July 2025)PAR template (empty) - when prepared based on FAR (July 2025) 

CMDh letter for MAHs for medicinal products containing active ingredients in the form of Mesilates, Isetionates, Tosilates or Besilates (February 2008)

Bridging requirements for formulations in a well-establish use application

In follow up to the publication of the ICH E20 draft Guideline “Adaptive Designs for Clinical Trials” in June 2025, the EWG has also prepared a Step 2 informational presentation.

The ICH Secretariat is pleased to announce the release of Training Modules 1 to 7 on ICH Q2(R2) “Validation of Analytical Procedures” and ICH Q14 “Analytical Procedure Development”.