PEI – Bulletin on Drug Safety

Bul­letin on Drug Safe­ty – Cur­rent Is­sue 3/2022 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 “Blue Hand” – Training materials as an important component of drug safety
  • Frequency of adverse reactions in treatment with cannabis medicinal products: Results from the BfArM companion survey
  • Responsibilities of the Paul-Ehrlich-Institut pursuant to the new regulation on in vitro diagnostic medical devices
  • Teratogenic risks of medicinal substances and commissioned BfArM training materials – how well known are they? An interview-based project
  • Messages from BfArM and PEI
  • PRAC recommendations within EU referral procedures – July to September 2022
  • Revised product information wording – Extracts from the PRAC recommendations on signals
  • References to “Dear Doctor Letters” (Rote-Hand-Briefe) and safety information

Further Information

Bulletin on Drug Safety, Issue 3/2022 (German only)