EMA Widens Stakeholder Access To EU Adverse Drug Reaction Reports
This article was originally published in SRA
Executive Summary
Drug manufacturers, regulators, the public, health professionals and academia are to have greater access to information on suspected drug adverse reactions (ADRs) after the European Medicines Agency revised its policy on access to the adverse reaction database, EudraVigilance, to take account of changes in the EU pharmacovigilance legislation and other developments1,2.