Some Other Ideas About the Future of Pharmacovigilance

Abstract

It is perceived that, during this century, pharmacovigilance has evolved to a more complex discipline: new technological developments, a refinement in its methods, new tasks and, overall, new legislations have been the most remarkable landmarks. A big corpus of legislation has been implemented in the last few years, particularly those coming from the main regulatory agencies―the Food and Drug Administration and the European Medicines Agency. Particularly remarkable have been the 16 volumes of legislation released by the European Medicines Agency, intended to regulate these activities. While legislation tries to control activities, we do not know the exact amount of normative control that is necessary to improve these activities; in fact, we do not really know if a new legislation is able by itself to improve these activities. What is certain is that the workload in the pharmacovigilance centres has been considerably increased along these last years; a substantial part of this workload is devoted to paperwork.