EMA announced a series of initiatives to strengthen the inclusion of women’s health considerations in medicines development and regulation. A dedicated workshop will take place on 28‑29 September, bringing together regulators, industry, academia and patients to map gaps and set priorities. Current actions focus on three pillars: ensuring women are adequately represented in clinical trials, assessing sex‑specific differences in efficacy, safety and dosing in product labelling, and improving data on medicine use during pregnancy and breastfeeding. EMA will analyse data from the Clinical Trials Information System, support post‑authorisation studies, refine pharmacovigilance for pregnant women and promote early engagement through its Innovation Task Force. The workshop findings will be published in a report to guide future work.
© European Medicines Agency (1995‑).
Summary adapted from EMA materials available at https://www.ema.europa.eu
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