A review on interrelation among post-authorisation study, regulatory action and pharmacogenetics in pharmacovigilance

Abstract

Pharmacovigilance system is the recent approach to control the incident of ADRs which is hazardous for patients both physical and mental health. Researchers are continuously trying to develop methods that can predict the ADR before it occurs and assure the patient‘s safety. The global scenario of this system is more advanced compared to Bangladesh and getting stronger day by day. Pharmacovigilance method can be described as the fusion of administrative action, clinical trials, studies done on authorized drugs, pharmacogenetics, epidemiology, signal detection and management, statistics, IT sector, maintaining database etc. However, the main focus of this paper is to detect the liaison among post-authorisation safety check, genetic factors and enactment of laws in the evolvement of pharmacovigilance system. The findings of the study can help to show a huge scope in the advancement of pharmacovigilance.