Challenges and Expectations Regarding a Modern Drug Dossier

Abstract

For nearly 40 years, drug dossiers have supported the quality, safety and risk/benefits of medicinal products - essentially becoming the passport that every drug requires to enter the market. However, because of changing market conditions and the increasing policy of cost-containment, a good drug dossier, with its duly compiled quality, safety and efficacy reports, is no longer sufficient. Thus the traditional drug dossier will soon be replaced some day by compounded e-documents, submitted in XML format, reviewed and approved on-line by the regulators, under the scrutiny of patient groups and with the final blessing of governmental and private payers.