The Concept of Pharmacovigilance
a new drug is authorised for sale to members of the public, it
undergoes years of testing in both animals (pre-clinical) and human
beings (clinical trials). These tests are done in order to understand
how the drug will potentially work in humans and what adverse effects
are likely to occur.
drug marketing authorisation is granted following careful evaluation of
clinical trial reports submitted to regulatory authorities. However,
clinical trials have limited ability to reveal rare and long term
adverse effects. Furthermore, patients selected for clinical trials are
carefully screened and may not fully reflect the real-life population
exposed to a given drug.
monitoring for adverse effects, after the drug has been marketed and
given to many more patients, is therefore important in order to reveal a
fuller pattern of adverse effects. It is through pharmacovigilance
activities that adverse drug effects are monitored on a continuous basis
to ensure that patient safety is not compromised. To learn more about pharmacovigilance, please see below for some selected topics.