Bewertung der neuen EG-rechtlichen Anforderungen an die Pharmakovigilanz aus Sicht der pharmazeutischen Industrie
Dr. Elizabeth Storz1, Dr. Wilhelm-Hubertus Franzen2, Dr. Dieter Fritsch3
vfa – Die forschenden Pharma-Unternehmen1, Berlin, Takeda Pharma GmbH2, Aachen und Merck Serono GmbH3, Darmstadt
Evaluation of New EC Requirements for Pharmacovigilance from the Pharmaceutical Industry Viewpoint Extensive proposals for strengthening pharmacovigilance in Europe were presented by the European Commission in December 2008. After two years of consultation these proposals were passed and the final versions of the Regulation and the Directive were published on December 31, 2010. The requirements of the Directive now must be implemented by the Member States by July 2012. Extensive changes can be expected in the areas of periodic safety update reports, publication of documents and information via web portals, reporting rules and performance of post-authorization safety and efficacy studies. Many of these measures will improve transparency and will lead to simplification of pharmacovigilance. Others are seen more critically by the pharmaceutical industry. This article will evaluate some of the most important changes from the pharmaceutical industry viewpoint.