From November 22, 2017, EudraVigilance, the report database specialized on the unwanted effects of drugs use, is going to be updated. The EMA (European Medicines Agency) collects through this site the submitted statements by competent authorities and marketing authorization holders. EudraVigilance database is open to public since 2012 with the aim to further boost transparency on potential risks and benefits of drug use.
EudraVigilance
Since 2011, EudraVigilance collects namely information on suspected adverse reactions to medicines/drugs. The reports enable EMA to evaluate medicines/drugs safety during their development process and after their authorization in the European Economic Area.
The reports are submitted by national competent authorities, marketing authorization holders and sponsors of clinical trials.
New EudraVigilance system benefits
With the update of the European law on pharmacovigilance, the EMA will launch in November new features in its EudraVigilance system:
– Superior detection and analysis tools enabling rapid action to protect public health ;
– Improved quality and completeness of ICSR data; better searchability and data analysis ;
– Enhanced scalability of the EudraVigilance system; the system will also collect reports of non-serious cases ;
– Simplified reporting of ICSRs to EudraVigilance and the rerouting of ICSRs to Member States ;
– Enhanced collaboration between EMA and WHO; EMA will provide data to WHO directly through EudraVigilance.
