Paul-Ehrlich-Institut

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Bul­letin on Drug Safe­ty - Cur­rent Is­sue 3/2021 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 on current aspects of the assessment of drugs from both federal institutes. 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 language.

Topics of the Current Issue

  • Editorial: drug safety and pharmacovigilance in Germany and Europe
  • Evaluation of the risk of leukemia in the treatment of beta-thalassemia with the gene therapy Zynteglo - European referral procedure (Referral Procedure, Article 20 of Regulation (EC) No 726/2004)
  • Pharmacovigilance inspections and special aspects in times of pandemic
  • News from the BfArM - the 2021 summer meeting of the Expert Advisory Committee for Prescription-Only Issues
  • PRAC recommendations within the framework of EU referral procedures – July to September 2021
  • Revision of the product information wording
  • References to ‘Dear Doctor Letter’ (Rote-Hand-Brief) and safety information

Further Information

Bulletin on Drug Safety, Issue 3/2021 (German only)
www.pei.de/bulletin-safety

Updated: 24.09.2021