EMA details upcoming Eudravigilance changes
These amendments include better detection of new or changing safety issues, allowing regulators and pharma companies to take rapid action to protect public health
The European Medicines Agency (EMA) has released a plan detailing upcoming changes to its EudraVigilance, its web-based adverse reaction reporting system.
These amendments include better detection of new or changing safety issues, allowing regulatory authorities and pharmaceutical companies to take rapid action to protect public health, in addition to better data analysis tools to support safety monitoring by European Union (EU) member states.
Also included is higher quality data and improved search functionality allowing data to be analysed more efficiently; compliance with international data standards for individual case safety reports; improved performance and scalability to cope with increases in users and resulting data volumes; simplified reporting for marketing authorisation holders; and better collaboration with the World Health Organisation (WHO) to exchange information on monitoring medicines.
The plan details the technical changes as well as business process changes
An EMA note said: 'The plan details the technical changes as well as business process changes in relation to reporting, managing and analysing individual case safety reports (ICSRs) from medicines in clinical use and from clinical trials.'
EudraVigilance has been operating since 2001 and EMA is upgrading its systems to take account of updates to the pharmacovigilance and clinical trials legislation and to deliver better safety monitoring for medicines. It currently registers more than one million adverse drug reaction reports each year.
EMA has also published an implementation guide with specific EU regional requirements and supporting technical documents.