ICH E21 Guideline: Inclusion of Pregnant Women in Clinical Trials

GUIDANCE DOCUMENT - OPEN FOR COMMENTS

E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials - Draft Guidance for Industry

E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials | FDA

The ICH E21 Guideline aims to provide clear recommendations for the appropriate inclusion and retention of pregnant and breastfeeding women in clinical trials. Its goal is to support the development of robust data that allows for evidence-based decision-making about the safe and effective use of medicinal products by these populations and their healthcare providers.

Scope

• Applies to pre- and post-marketing clinical trials.

• Relevant for both general indications and those specific to pregnancy or breastfeeding.

• Inclusion should be considered for all drugs likely to be used by women of childbearing potential, especially where there is unmet medical need.

Background

• Many pregnant and breastfeeding women have chronic or acute conditions needing treatment.

• Pregnancy alters drug PK/PD, potentially requiring dose adjustments.

• Despite this, they are routinely excluded from trials or withdrawn if pregnancy occurs during the study.

• This leads to a lack of safety and efficacy data, resulting in:

  • Discontinuation or avoidance of necessary treatment

  • Use of inappropriate or harmful therapies

  • Incorrect dosing

  • Unwarranted discontinuation of breastfeeding or treatment

Public Health Impact

• The absence of data contributes to serious risks for mothers, fetuses, and infants and may have broad public health consequences.

Comments should be submitted by 09/19/2025