Paul-Ehrlich-Institut

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Bulletin on Drug Safety - Current Issue 2/2023 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: The Pharmacovigilance Risk Assessment Committee - essential for drug safety
  • Anti-obesity drugs - approved drugs and potential new therapeutic options
  • Safety profile of COVID-19 vaccines - status at 31.03.2023
  • Ten years of PRAC - the Pharmacovigilance Risk Assessment Committee
  • Prescription of thyrostatic drugs in women of reproductive age and in pregnancy
  • Reports from BfArM and PEI
  • PRAC recommendations within the framework of EU referral procedures – April to June 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 2/2023 (German only)
www.pei.de/bulletin-safety

Updated: 29.06.2023