Biopharma Business

On May 22, 2017, the European Medicines Agency (EMA) announced that its Pharmacovigilance Risk Assessment Committee has completed an audit and evaluation of the new EudraVigilance information system for tracking suspected adverse reactions to authorized drugs and medicines being studied in clinical trials in the European Economic Area. The new system, which goes live on Nov. 22, 2017, will feature enhanced functionalities for reporting and analyzing adverse events. EMA stated in a press release that national competent authorities, marketing authorization holders, and clinical trial sponsors should make sure their processes and IT structures are compatible with the new system.

Specifically, the new system will provide simplified reporting of individual case safety reports (ICSRs) and the re-routing of ICSRs to Member States. The system will enable rapid action due to better detection of new or changing safety issues. A public portal, adrreorts.eu, will increase transparency. The system’s capacity has been increased, and search and analysis of data has been enhanced. Collaboration between the World Health Organization (WHO) and EMA will make reports of suspected adverse reactions available to the WHO Uppsala Monitoring Center directly from the EudraVigilance system.

Training on the new system will be provided by EMA. A test environment of the new system will be available on June 26, 2017. Patient and healthcare provider reports of adverse reactions will continue as usual, and there will be no changes to the reporting of suspected unexpected serious adverse reactions during clinical trials.