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
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”.
In follow up to the publication of the ICH M4Q(R2) draft revised Guideline in May 2025, the EWG has also prepared a Step 2 informational presentation.
The ICH E20 draft Guideline on “Adaptive Design for Clinical Trials” has reached Step 2b of the ICH Process on 25 June 2025 and entered the Step 3 public consultation period.
The ICH E21 draft Guideline on “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials” reached Step 2b of the ICH Process in May 2025 and has entered the consultation period.
VARIATIONS FRAMEWORK Variations Regulation The revised Variations Regulation applies since 1 January 2025 for variation applications implemented and submitted from 1 January 2025. Variations Guidelines A single cut-off date for the entry into application (i.e., 15 January 2026) is set out in the final version of the Variations Guidelines. Until 15 January 2026, marketing authorisation [...]