Bulletin on Drug Safety - Current Issue 1/2025 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: Transparency as a pillar of medicinal product safety
- Statin therapy – inter-individual variability in therapeutic effects
- Atomexitin: Update of the summary of product characteristics and package leaflet as a result of the European PSUR Single Assessment
- Pharmacovigilance report on the use of COVID-19 vaccines – status as of 31.12.2024
- Risk minimisation for medicinal products and module XVI of the EU guideline on good pharmacovigilance practices: changes and additions in the new version (revision 3)
- Use of opioid analgesics in Germany
- Reports from BfArM and PEI
- PRAC recommendations within EU referral procedures – January to March 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 1/2025 (German only)
www.pei.de/bulletin-safety
