PharmacovigilanceOfficial

BfArM and PEI back #MedSafetyWeek, urging adverse reaction reports from 2 to 8 November

🇩🇪 BfArM · Fri 30 Oct 2026

Germany's two medicines safety authorities join the international social media campaign, which urges patients and health professionals to report suspected side effects rather than ignore them.

The Paul-Ehrlich-Institut (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM) have issued a joint press release, number 11/26 of 30 October 2026, announcing their participation in #MedSafetyWeek. The campaign runs from 2 to 8 November 2026 under a motto that translates as "don't ignore side effects, report them".

The Uppsala Monitoring Centre, a WHO collaborating centre, coordinates the campaign. According to the release, more than 130 organisations from over 120 countries take part, and the message is distributed in more than 60 languages. The two German authorities, which monitor medicines safety within their respective remits, are taking part again this year.

The campaign targets healthcare and pharmacy professionals, patients and their relatives. It stresses that adverse reactions can appear suddenly or develop gradually, sometimes only after prolonged use, and that some are not noticeable without medical tests. People who notice a possible side effect are advised to discuss it with a doctor or pharmacist. Suspected reactions can be reported directly to BfArM or PEI through the online portal www.nebenwirkungen.bund.de.

The PEI and BfArM presidents both stress that suspected-case reports provide evidence of previously unknown risks, and that the authorities keep monitoring safety after authorisation. BfArM says the reporting threshold is deliberately low so that any suspicion reaches the agency quickly. The authorities also ask the public to share their campaign posts during the week.

The release is an awareness exercise and sets no new regulatory requirements. As general context, spontaneous reports of suspected adverse reactions are one of the main inputs for signal detection in post-authorisation pharmacovigilance.

What it means for your team

  • No new obligations arise from the announcement; it is a public awareness campaign.
  • Spontaneous reporting underpins signal detection, so PV teams may see more consumer and healthcare professional reports around and after 2–8 November.
  • Marketing authorisation holders may wish to check that their own reporting channels and case-intake processes can handle a short-term rise in volume.
  • Germany's central reporting route for suspected reactions remains the nebenwirkungen.bund.de portal, serving both BfArM and PEI.

Official source: BfArM ↗

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

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