The European Commission, DG Enterprise and Industry, Pharmaceuticals Unit commissioned the Fraunhofer Institute for Systems and Innovation Research together with the Coordination Centre for Clinical Studies at the University Hospital of Tübingen (KKS-UKT) with the project “Assessment of the European Community System of Pharmacovigilance” (EU Contract-No. FIF.20040739).

Pharmacovigilance, i.e. the continuous monitoring of the safe use of medicinal products, is critical to the protection of public health. Community legislation is in place to ensure that all stakeholders including National Competent Authorities, marketing authorisation holders, applicants and sponsors of clinical trials in the European Economic Area (EEA) collect, collate and exchange information on adverse drug reactions. This is in order to ensure that rapid and appropriate responses are made to potential safety issues related to medicinal products.

No comprehensive, systematic assessment of the European Community system of pharmacovigilance had been made for all 25 EU Member States so far. The study tried to fill this gap. On the basis of conceptual and methodological considerations, it aimed to assess the current system of pharmacovigilance at a European and Member State level, including the identification of its strengths and weaknesses, and made recommendations to increase the robustness of the European Community system of pharmacovigilance.

The following tasks were accomplished:

  • Task 1: System analysis and description of status quo
  • Task 2: Definition of goals in respect of effectiveness and efficiency
  • Task 3: Identification of critical success factors
  • Task 4: Identification and definition of performance indicators
  • Task 5: Gap analysis to identify strengths and weaknesses
  • Task 6: Identification of best practice
  • Task 7: Elaboration of recommendations

The project analysed the relevant documents and carried out personal interviews with all respective competent authorities, as well as with other experts. A workshop was held at the end of the project to discuss policy recommendations.

Duration: 12/2004 – 10/2005

Funding: European Commission, Enterprise and Industry DG, Pharmaceuticals Unit (Service contract)

Partner: Coordination Centre for Clinical Studies at the University Hospital of Tübingen (KKS-UKT)


  • Prof. Dr. H. G. M. Leufkens, Chair of Pharmacoepidemiology, Utrecht University, Dept. of Pharmacoepidemiology, Utrecht, the Netherlands
  • Prof. Dr. U.M. Gassner, Department of Public Law and Research Centre for Law of Medicinal Products at the University of Augsburg, Germany

Coordination: Thomas Reiss/Bernhard Bührlen at Fraunhofer ISI

Publication: Bührlen, B.; Reiß, T.; Beckmann, C.; Gassner, U.M.; Gleiter C. H. (2006): Assessment of the European Community System of Pharmacovigilance. Stuttgart: Fraunhofer IRB, 190 p.

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