Bulletin on Drug Safety - Current Issue 3/2023 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 risk 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 on pharmacovigilance and research in this area.
The publication is available in German only.
Topics in the Current Issue
- Editorial: Launch of the #MedSafetyWeek social media campaign promoting medicinal product safety on 6 November
- 2021 Haemovigilance report from the Paul-Ehrlich-Institut: evaluation of reports of serious adverse reactions and incidents in accordance with section 63i of the AMG – summary
- Monitoring the blood supply in Germany: data based on the reports submitted in accordance with section 21 of the TFG and the data of a pilot study
- Product-specific communication from the BfArM regarding application risks
- Side effects reported by doctors
- Reports from BfArM and PEI
- PRAC recommendations within the framework of EU referral procedures – July to September 2023
- Revision of product information wording – excerpts from the PRAC recommendations on signals
- References to ‘Dear Doctor Letters’ (Rote-Hand-Briefe) and safety information
Further Information
Bulletin on Drug Safety, Issue 3/2023 (German only)
www.pei.de/bulletin-safety
