Paul-Ehrlich-Institut

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Bulletin on Drug Safety - Current Issue 1/2023 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 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: Safer medicines through the use of real-world data
  • Data on vaccine pharmacovigilance from 2019 to 2021
  • Use of register data for regulatory decision-making
  • The Health Data Lab, European Health Data Space and DARWIN EU® – new opportunities for drug research with real-world data
  • Pharmacological influence of steroidal sex hormones on the development of mental illness
  • Reports from BfArM and PEI
  • PRAC recommendations within the framework of EU referral procedures – January to March 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 1/2023 (German only)
www.pei.de/bulletin-safety

Updated: 30.03.2023