Paul-Ehrlich-Institut

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Bulletin on Drug Safety - Current Issue 4/2025 Published

The Bulletin on Drug Safety is a cooperation between the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut (PEI). The quarterly publication provides information from both federal institutes on current aspects of the assessment of drugs. It focuses on pharmacovigilance – the continuous monitoring and evaluation of drug safety before and after marketing authorisation. The Bulletin includes articles on individual drugs as well as background information for understanding pharmacovigilance and research in this area.

The publication is available in German only.

Topics in the Current Issue

  • Editorial: The future of drug safety – innovations that walk the line between progress and safety
  • Signal procedures for pancreatin (pancreatic powder from pigs) – risk of infection from viral transmission
  • CAR T-cell therapy and secondary tumour development – coincidence or connection
  • 50 years of the Drug Commission of German Pharmacists (AMK) – a look at the past, present, and future
  • Descriptions of potency in medication plans – how to identify, report, and avoid issues
  • Reports from BfArM and PEI
  • PRAC recommendations within EU referral procedures – October to December 2025
  • Revised product information wording – Extracts from the PRAC recommendations on signals
  • References to direct healthcare professional communications (Rote-Hand-Briefe) and safety information

Further Information

Bulletin on Drug Safety, Issue 4/2025 (German only)
www.pei.de/bulletin-safety

Updated: 18.12.2025