PharmacovigilanceOfficial

German regulators' drug safety bulletin 3/2026 covers Ixchiq review, silicone oil droplets and OTC pharmacovigilance

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

The Paul-Ehrlich-Institut and BfArM have published the third 2026 issue of their joint quarterly bulletin, with features on a live vaccine reassessment and intravitreal therapy risks.

The Paul-Ehrlich-Institut (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM) have published issue 3/2026 of their joint Bulletin on Drug Safety. The quarterly publication reports on current aspects of medicinal product risk assessment, with pharmacovigilance at its centre.

Among the features is an article on Ixchiq, a live vaccine, whose benefit-risk balance is under reassessment at the EMA's Pharmacovigilance Risk Assessment Committee (PRAC). The piece appears on pages 7 to 11. Another article addresses silicone oil droplets in the vitreous body after intravitreal therapy with VEGF inhibitors, covering causes and risk minimisation.

The issue also includes a feature on over-the-counter medicines in pharmacovigilance and a piece on #MedSafetyWeek 2026, whose theme is "Side effects – don't ignore them, report them" (pages 15 to 22). The editorial is titled "New impetus for training materials".

Regular reference sections cover PRAC recommendations from EU referral procedures for July to September 2026, revised product information wording taken from PRAC signal recommendations, and pointers to Rote-Hand-Briefe (Direct Healthcare Professional Communications) and other safety information. The PEI's page was last updated on 29 September 2026.

What it means for your team

  • Safety teams responsible for Ixchiq should read the PRAC-focused article, as the bulletin describes the vaccine's benefit-risk balance as being reassessed.
  • Marketing authorisation holders of VEGF inhibitors for intravitreal use may want to review the article on silicone oil droplets and risk minimisation.
  • Regulatory affairs teams can use the bulletin's listing of PRAC signal recommendations and referral outcomes (July to September 2026) to check whether product information updates apply to their products.
  • OTC portfolio owners should note the issue's focus on pharmacovigilance for non-prescription medicines.

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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