PharmacovigilanceOfficial

Austria's BASG backs MedSafetyWeek 2026 and publishes 2025 pharmacovigilance report figures

🇦🇹 BASG · Tue 03 Nov 2026

BASG and AGES join the 11th international campaign urging reporting of suspected side effects, citing 14,528 Austrian pharmacovigilance reports in 2025 and a changed counting method.

Austria's Federal Office for Safety in Health Care (BASG) and the AGES agency are supporting the 11th #MedSafetyWeek, which runs from 2 to 8 November 2026. The campaign's message is that suspected adverse reactions should be reported rather than ignored. It is an awareness initiative and introduces no new regulatory requirements.

BASG says studies indicate only about 5 to 10 per cent of suspected adverse reactions are reported worldwide. It lists lack of time, perceived effort and a belief that a report changes nothing as typical reasons. AGES and BASG officials stress that a suspicion is enough, for example based on timing, and that causality need not be certain. They add that the safety assessment of an active substance is carried out at European level using EU-wide data.

BASG reviews and medically classifies each report before forwarding it to the European Medicines Agency's EudraVigilance database, where all European authorities can access it for ongoing monitoring. If new findings emerge, authorities may amend the package leaflet, inform healthcare professionals or require risk-minimisation measures. In serious cases a medicine can be withdrawn from the market.

In 2025 BASG received 14,528 reports on adverse reactions, interactions and medication errors. Marketing authorisation holders submitted 12,439, patients 1,006 and healthcare professionals 1,083. Since 2018 the total is 236,567. BASG notes that the 2025 figures are lower than those for the previous year because the statistics now count only initial reports, not follow-ups. It says this gives a more transparent picture.

Patients and relatives can report directly through BASG's online portal, and healthcare professionals are legally obliged to report adverse reactions. The campaign, launched in 2016, is coordinated by the Uppsala Monitoring Centre, the WHO collaborating centre for international drug monitoring. BASG says more than 130 organisations in over 120 countries are involved, and ICMRA members support it. Free campaign materials are available on the #MedSafetyWeek website.

What it means for your team

  • When comparing Austrian report volumes year on year, note that BASG has counted only initial reports since 2025, so earlier totals are not directly comparable.
  • Marketing authorisation holders were the source of most reports in 2025 (12,439 of 14,528), while patient and healthcare professional reports numbered about 1,000 each.
  • No new obligations arise from the campaign, but PV and communications teams may wish to align patient and healthcare professional outreach with the 2–8 November week; campaign materials are free.

Official source: BASG ↗

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

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