The European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have agreed on terms of reference for a joint cluster on pregnancy and lactation, aiming to foster a consistent global approach for evidence-based safe and effective use of medicines and vaccines during pregnancy and breastfeeding. The document, published by EMA on 17 July 2026, outlines the cluster's goals, participants, meeting schedule, and agenda-setting procedures.
The cluster, initially established on 14 February 2022, seeks to engage in product-specific discussions on data interpretation, clinical trial strategies, labelling, and risk management. It will also share best practices to address ethical, scientific, and regulatory barriers to include pregnant and breastfeeding individuals in clinical trials. The collaboration encourages early and aligned engagement with sponsors during product development and post-approval, and aims to foster sound non-clinical and clinical investigations, including novel trial designs and statistical methods.
Participants from each agency will include relevant staff members, with teleconferences chaired by a rotating agency every six months. Meetings are anticipated monthly, lasting approximately one hour, with ad-hoc meetings as needed. Observers from other regulatory authorities may join subject to agreement and confidentiality arrangements. The cluster will coordinate with other platforms, such as paediatric or pharmacovigilance clusters, to avoid duplication.
pregnant and lactating individuals stand to benefit from safer and more effective medicines, while pharmaceutical companies face potential changes in clinical trial requirements and data collection expectations. Regulatory agencies gain a harmonised framework for evaluation, and healthcare providers may receive clearer guidance on prescribing during pregnancy and lactation. The cluster's work could accelerate research in this historically understudied population, though it may also increase complexity for drug developers navigating multiple regulatory expectations.