The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals for several medicines during its meeting of 8-11 June 2026, according to a document published by the EMA on 6 July 2026. The recommendations include updates to product information for centrally authorised products (CAPs) and nationally authorised products (NAPs), as well as requests for supplementary information from marketing authorisation holders (MAHs).
The PRAC, which meets monthly to assess safety signals, discussed signals tracked in the European Pharmacovigilance Issues Tracking Tool (EPITT). For CAPs, the recommendations for product information updates have been endorsed by the Committee for Medicinal Products for Human Use (CHMP) at its plenary meeting of 22-25 June 2026, and corresponding variations will be assessed by the CHMP. For NAPs, national competent authorities (NCAs) of EU member states are responsible for ensuring adherence to the recommendations.
The document outlines that MAHs must keep product information up to date with current scientific knowledge, including PRAC conclusions, as required by EU regulations. Variations for CAPs follow established EMA procedures, while those for NAPs are handled at national level. The PRAC may also recommend additional analyses by the EMA or member states.
The recommendations impact pharmaceutical companies holding marketing authorisations for the affected medicines, as they must implement product information changes or provide supplementary data within specified timelines. National regulators in EU member states are tasked with overseeing compliance for nationally authorised products. Healthcare professionals and patients may see updated safety information in product leaflets and summaries of product characteristics. The EMA and national authorities coordinate to ensure consistent safety monitoring across the EU.
No further details on the specific signals or medicines were disclosed in the document, which serves as a procedural overview. The full list of recommendations is expected to be published on the EMA's dedicated webpage for PRAC safety signals.