FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

EMA to Overhaul EudraVigilance System for Monitoring Adverse Events

Nov. 4, 2015

The European Medicines Agency’s EudraVigilance system for monitoring adverse events is undergoing an overhaul to comply with new postmarketing clinical trials legislation, and regulators are readying drugmakers and national authorities for a new plan.

The electronic system’s role as gatekeeper of records will be formalized and consolidated. Individual case study reports will be sent directly to EudraVigilance, rather than national bodies, meaning most reports will flow straight to the agency. In addition, a new standard structured form will capture suspected unexpected serious adverse reactions.

The web-based risk management program, which began 14 years ago and now books around 1 million drug reactions each year, will include new data analysis and search tools to better track risk profiles for drugs.

EMA users will see new pharmacovigilance odds ratios, subgroup analysis, information on approved medicines, data quality monitoring and an electronic reaction monitoring report.  

In addition to tweaking the existing EudraVigilance structure, the EMA is adding two new functions. A new rerouting rules engine will pass on individual case study reports to national authorities, and marketing authorization holders also will have the option to download those specific to their products.

The plan also offers new business process details on reporting, managing and analyzing ICSRs, as well as timetables for companies and regulators to review. 

The agency says it will undergo a system audit ahead of the changes and offer educational manuals and training for regular users and sponsors. The full EMA plan can be read here: fdanews.com/EudraVigilance-Changes-2015.pdf.