PharmacovigilanceOfficial

PRAC publishes signal recommendations from its 28 September–1 October 2026 meeting

🇪🇺 EMA · PRAC · Mon 26 Oct 2026

The EMA's pharmacovigilance committee has released its recommendations on safety signals adopted at its latest plenary, though the detail was not available at the time of writing.

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has published its recommendations on signals adopted at the meeting held from 28 September to 1 October 2026. The item is dated 26 October 2026.

The source material available to VigiEye contains only the title of the publication. It does not set out which medicines or safety issues were assessed, nor what actions PRAC recommended. We are therefore unable to report on specific products, adverse reactions or outcomes.

By way of context, a PRAC signal assessment reviews information suggesting a new or changed risk linked to a medicine. It can lead to recommendations such as updates to the product information, further data collection or, in some cases, wider regulatory action.

Marketing authorisation holders and pharmacovigilance teams should consult the full document on the EMA website for the substances concerned and any recommended changes to product information.

What it means for your team

  • Check the full PRAC document on the EMA website to see whether any of your products or active substances are listed.
  • Pharmacovigilance teams should plan for possible product information updates or follow-up submissions arising from the recommendations.
  • Regulatory affairs teams should note the 28 September–1 October 2026 meeting date when tracking signal outcomes and any related variation timelines.

Official source: EMA · PRAC ↗

Article written by VigiEye from the official source (EMA · PRAC). AI-assisted; check the source before acting.

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