The International Council for Harmonisation (ICH) has recently released two draft guidelines for public consultation. One draft guideline focuses on assessing new drugs for pregnant populations in clinical trials, while the other provides updates to the information requested in the quality section of the Common Technical Document (CTD).
In other recent actions, ICH also released a concept paper that proposes a new addendum for assessing nitrosamine impurities in drug products.
These advances were announced on 21 May following its 13-14 May meeting in Madrid (RELATED: ICH announces new topics, draft guidelines for consultation, Regulatory Focus 21 May 2025).
The ICH E21 guideline aims to establish a globally accepted framework and best practices for including and retaining pregnant and breastfeeding individuals in clinical trials. It addresses principles for collecting a “robust” set of safety, efficacy, and pharmacokinetic data for his population…
