Active pharmacovigilance

Depending on the nature of the potential and identified risks, the use of active pharmacovigilance systems may be advisable due to a lack of safety information beyond the data available from clinical trials carried out in the pre-authorization stage. Active pharmacovigilance incorporates complementary safety information and may be recommended in certain scenarios, such as:

1.  Authorization of new medicinal products based on only a few or small-scale clinical trials
2.  Repositioning of a therapeutic drug for new therapeutic indications (new populations)
3.  Insufficient information on safety in special populations (e.g., diabetics, pregnant women)
4.  Insufficient information on the safety of long-term use
5.  Need for information to fill gaps in available safety information or to confirm/refute signals