Study on Role of Postmarketing Surveillance in New Drug Development

Post marketing surveillance aims to monitor and evaluate both the beneficial and adverse effects of drugs after approval for general use. The Health Council in the Netherlands has defined post marketing surveillance (PMS) as 'The systematic surveillance and scientific study of all intended and unintended effects of medicines on human health, after their release for marketing'. Spontaneous reports should be supplemented by analytical studies, monitoring of cohorts of users of new drugs, using record-linkage to track their subsequent outcomes and to interpret the results of such analyses in the context of variability of drug exposure. Furthermore, the introduction of drugs with a new pharmacological profile especially requires post marketing surveillance of adverse events, as illustrated by the case of ibopamine. Programs for collecting and reporting safety information on drugs such as adverse drug reactions include an adverse drug reaction reporting system undertaken by pharmaceutical companies, the drug safety information reporting system undertaken by medical personnel, and the WHO International Drug Monitoring Program whereby drug safety information is exchanged among various countries. The present work has been designed to create awareness and knowledge about the post-marketing surveillance research and its emerging role in the new drug development.