Pharmacovigilance and expedited drug approvals

Abstract

Pharmacovigilance is the detection and assessment of adverse events related to any drug used in clinical practice. In Australia adverse events can be reported to the Therapeutic Goods Administration. Reports are encouraged, even if the drug is old or the prescriber is only suspicious of an adverse event. Australian information about adverse events can be found online in the Database of Adverse Event Notifications and in the publication Medicine Safety Update. The Therapeutic Goods Administration is currently exploring expedited approval pathways to enable some drugs to reach the market quickly. As there will be limited clinical data about these drugs, postmarketing pharmacovigilance will be of increased importance.