EMA Publishes Comments on ICH E21

The EMA published the comments on the draft ICH Guideline E21 in a consolidated tabular overview. The comments received will be discussed and implemented by the expert group. However, the final guideline is not expected to be published until early 2028.

Background

In June 2023, the International Council for Harmonisation (ICH) decided to establish an expert group to draft Guideline E21 on the inclusion of pregnant and breastfeeding individuals in clinical trials. In May 2025, the ICH published the draft E21 guidance on its website for public consultation. In June 2025, the EMA also published this draft in Europe for comment by experts and the public until September 2025.

In addition, the EMA has published a draft guideline on "non-inferiority and equivalence comparisons in clinical trials" for comment. Comments can be sent to the EMA until 31 May 2026. The new document provides guidance on the planning, conduct, analysis and interpretation of non-inferiority and equivalence comparisons in clinical trials.

The new guideline will replace the two existing guidelines "on the choice of the non-inferiority margin" (EMEA/CPMP/EWP/2158/99) and "Points to consider on switching between superiority and non-inferiority" (CPMP/EWP/482/99).

More information is available in the ICH E21 guideline on inclusion of pregnant and breastfeeding individuals in clinical trials – Scientific guideline published on the EMA website.