New approaches to strengthen pharmacovigilance

Until recently, pharmacovigilance was mainly based on spontaneous reports, which provide low evidence of risks associated with medicines. Today, the importance of the full spectrum of the evidence hierarchy is recognised. This article reviews new approaches and data sources used in pharmacovigilance and shows that individual case safety reports, observational data, clinical trials and meta-analyses have unique characteristics that complement each other for the overall benefit–risk evaluation of medicines.