Pharmacovigilance
The World Health Organization (WHO) defines pharmacovigilance as: A set of practices aiming at the identification, understanding, and assessment of the risks associated with drugs.
The process of pharmacovigilance starts from the pre-marketing phase of a new drug and continues beyond the post-marketing phase – covering the entire life cycle of the product.
Though a new drug molecule must undergo various clinical and non-clinical trials, pharmacovigilance is necessary because the information generated from clinical trials is not sufficient to evaluate the safety of a drug when it comes to adverse drug reactions.
This is because clinical trials are limited in the number of patients, and the conditions for the use of medicines in clinical trials differ from those in clinical practice and for regular use by patients.