EMA told to broaden access to ADRs
This article was originally published in Scrip
Executive Summary
The European Ombudsman has asked the European Medicines Agency to review its transparency policy so that the public may have access to suspected serious drug adverse reaction reports, regardless of the form in which they are held. The EMA has until 31 July to submit a response to the ombudsman, who investigates complaints about maladministration in European Union institutions or bodies.