PharmacovigilanceOfficial

Paul-Ehrlich-Institut backs #MedSafetyWeek 2026 push to report every suspected side effect

🇩🇪 Paul-Ehrlich-Institut · Wed 28 Oct 2026

The German regulator is promoting the 2–8 November campaign, stressing that spontaneous reports of suspected adverse reactions remain central to post-authorisation safety monitoring.

The Paul-Ehrlich-Institut (PEI) has announced its support for #MedSafetyWeek 2026, which runs from 2 to 8 November under the slogan "Side effects – don't ignore them, report them". The annual campaign is coordinated by the Uppsala Monitoring Centre (UMC), an independent non-profit organisation that has run the WHO Programme for International Drug Monitoring for more than 40 years.

This year's message is that side effects take many forms and do not always appear straight away. The PEI says any adverse reaction observed in connection with a medicine or vaccine should be taken seriously, documented and reported. Suspected reactions should not be played down or overlooked, it says, so that risks are spotted early and medicine safety improves.

The institute explains why spontaneous reporting matters. At authorisation, knowledge of side effects rests mainly on clinical trials with limited numbers of participants and on preclinical work. Vulnerable groups such as pregnant or breastfeeding women and children are usually not represented. Spontaneous reports capture real-world experience, helping to identify very rare reactions that trials often miss. They can also point to off-label use, medication errors and interactions with other medicines or foods.

In Germany, reports come from doctors, dentists, veterinarians and pharmacists, other health workers, public health offices, patients and their relatives. The PEI says herbal, alternative-medicine and over-the-counter products should be reported, as should reactions already listed in the package leaflet. The reporting threshold is deliberately low: proven causality is not required, and a suspected link, for example based on timing, is enough. For vaccines, blood products, genetically engineered plasma proteins and tissue preparations, separate and wider statutory reporting obligations apply to treating or vaccinating doctors and to blood, plasma and tissue establishments.

The item is an awareness message and introduces no new regulatory requirements. The UMC supplies campaign materials that regulators, pharmacovigilance centres, companies and international organisations can share online or use at events in schools, hospitals and pharmacies.

What it means for your team

  • No new obligations arise, but the PEI reiterates that the reporting threshold is low and that suspicion of a link is sufficient.
  • Marketing authorisation holders and PV teams can use UMC campaign materials in their own channels and should expect a possible uptick in incoming reports around the campaign week.
  • Reports on OTC, herbal and alternative products and on reactions already listed in the leaflet are explicitly encouraged, which may affect case volumes and processing.
  • Vaccines, blood products, plasma proteins and tissue preparations remain subject to separate, extended statutory reporting duties in Germany.

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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