Privatsphäre-Einstellungen

Der regelmäßig aktualisierte Bericht über die Unbedenklichkeit von Arzneimitteln (Periodic Safety Update Report / PSUR) als wichtiges Element der Arzneimittelsicherheit

Möglichkeiten für gemeinschaftliche Aktivitäten

Prof. Dr. Barbara Sickmüller¹, Dr. Jenny Gebhardt² und Dr. Simone Breitkopf¹

Bundesverband der Pharmazeutischen Industrie e.V. (BPI)¹, Berlin, und BPI Service GmbH, Berlin²

The „4. Bekanntmachung zur Anzeige von Nebenwirkungen und Arzneimittelmißbrauch des BfArM und PEI (29 April 2005)“ defines the mandatory features of Periodic Safety Update Reports (PSURs). Marketing authorisation holders are required to submit these reports at regular intervals; the time frames of these intervals are defined according to the international birth date of the product for which the report is submitted. The object of these safety reports is to provide a systematic overview of the cumulative safety data for the active ingredient of the product under scrutiny collected during the reporting period. In addition, this data is then to be analysed to allow an assessment of the product’s risk-benefit-profile. As such, PSURs play an important role within the European and worldwide pharmacovigilance system, as it requires the marketing authorisation holder to present the relevant safety data in a succinct, compact and analytical manner. The German Pharmaceutical Industry Association (BPI) e.V., in cooperation with BPI Service GmbH, has initiated a project for a substance-oriented „pooled“ literature research and PSUR writing service that allows marketing authorisation holders to out-source these activities at a comparatively low cost.