Article originally published in the Food and Drug Law Journal (with permission from FDLI), August 2008
Pharmacovigilance is a global public health activity that is currently undergoing a considerable amount of regulatory, social and political change. The standards expected by society have been raised following high-profile product withdrawals. Industry, regulatory authorities and consumers are now focusing on a more proactive, risk management based approach to drug safety monitoring. There has been a shift from the formulaic collection, classification and reporting of adverse event reports to a more holistic focus on any information suggesting a change in a product’s risk benefit profile.
There has also been a realization that effective pharmacovigilance must be global. Companies and regulatory authorities must receive and react to information suggesting a change in risk-benefit profile wherever it arises. The past 20 years has therefore seen a steady drive towards global harmonization of safety reporting definitions and standards.
Continue Reading Global Harmonization Is Not All That Global: Divergent Approaches in Drug Safety