Discussion Regarding ICH E21 Guideline in Clinical Trials Involving Pregnant and Nursing Participants

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has prepared a new guideline (E21) aimed at ensuring the safety of pregnant and breastfeeding individuals participating in clinical trials. The Expert Working Group (EWG) of the ICH has been responsible for the development of this guideline.

The ICH, which brings together global regulators and the pharmaceutical industry, was officially established by its Steering Committee. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has been an implementing member since at least November 1, 2004. However, there is no specific public record of the MHRA alone officially appointing the Expert Working Group on a precise date separate from the ICH formation process.

The E21 guideline outlines the principles and conditions necessary for the enrolment and retention of pregnant and/or breast-feeding individuals in clinical trials and overall drug development plans. It covers scientific, regulatory principles, and ethical considerations for including these individuals in clinical trials to ensure their safety and that of their child.

The MHRA, which became a full member of the ICH in May 2022, is seeking views on the draft E21 guideline from UK stakeholders, including patients and the public. Stakeholders can provide comments and recommendations through the ICH Public Consultation Comments template and emailing it to the specified MHRA website address. The subject line of the email should include 'E21 consultation'.

It is important to note that one response per organization is allowed during the consultation process. The MHRA will review feedback from UK and ICH region stakeholders regarding the E21 guideline. The ICH E21 EWG will discuss the feedback received during the consultation; however, they will not publish a full response to this consultation.

The consultation process for the E21 guideline is open to UK stakeholders. The ICH aims to harmonise the development of safe, effective, and high-quality medicines, and the E21 guideline emphasizes that pregnant and breast-feeding individuals should, in principle, be eligible for inclusion in clinical trials of medicines appropriate for their medical condition.

Stakeholders are encouraged to submit their comments and recommendations before the deadline, which has not been specified in the current paragraph. For more information, please visit the MHRA website.

Discussion Regarding ICH E21 Guideline in Clinical Trials Involving Pregnant and Nursing Participants