PharmacovigilanceOfficial

PEI and BfArM back #MedSafetyWeek campaign urging adverse reaction reports

🇩🇪 Paul-Ehrlich-Institut · Sat 31 Oct 2026

Germany's two medicines authorities join the international 2–8 November campaign calling on professionals and patients to report suspected side effects so risks are spotted earlier.

The Paul-Ehrlich-Institut (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM) have issued a joint press release in support of #MedSafetyWeek, which runs from 2 to 8 November 2026. The campaign urges people to report suspected adverse drug reactions so that possible medicine risks can be identified early.

The Uppsala Monitoring Centre, a WHO collaborating centre, coordinates the initiative. According to the release, more than 130 organisations in over 120 countries are spreading the campaign messages in more than 60 languages. PEI and BfArM are taking part again this year.

This year's motto is to not ignore side effects but to report them. The message is aimed at healthcare and pharmacy professionals, patients and their relatives. People who notice a possible side effect are advised to discuss it with a doctor or pharmacist. In Germany, suspected reactions can be reported directly to BfArM or PEI through the online portal at www.nebenwirkungen.bund.de.

The agencies say that, after authorisation, they continue to monitor medicines safety in their respective areas of responsibility, and that suspected-case reports can reveal previously unknown or rare reactions. PEI president Stefan Vieths stressed that every report counts. BfArM president Karl Broich said each suspected case is taken seriously, that the reporting threshold is deliberately low, and that the authority examines new findings and takes targeted action where needed.

The campaign relies mainly on social media. The authorities ask the public to share the posts of participating regulators during the campaign week. It is an awareness drive and introduces no new reporting obligations.

What it means for your team

  • No new regulatory requirement: this is an awareness campaign for spontaneous reporting, not a change to legal obligations.
  • Expect more patient and healthcare-professional reports to reach PEI and BfArM around and after 2–8 November, which may feed signal detection.
  • Marketing authorisation holders and PV teams may wish to make sure their own routes for receiving and forwarding adverse reaction reports are working smoothly during the campaign week.
  • German reports can go straight to the national portal, which regulators describe as the simple, direct channel for suspected adverse reactions.

Official source: Paul-Ehrlich-Institut ↗

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

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