Pharma's Well-Intentioned 'Improvements' To ICSRs Causing Problems In EudraVigilance
EU marketing authorization holders are unknowingly duplicating individual case safety reports in the revamped EudraVigilance database, a senior regulator warns.
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Following the launch of the revamped EudraVigilance database last November, a senior EU regulator believes these are exciting times to be involved in the pharmacovigilance arena. Companies, however, are struggling with the additional burden introduced by the new system and have suggested several improvements.
After months of preparations, the European Medicines Agency’s improved pharmacovigilance database has gone live on schedule.
The European Medicines Agency will use a phased approach to help companies comply with their obligation to monitor the revamped EU pharmacovigilance database and to report validated signals. Under a pilot to be launched on Feb. 22, 2018, companies will only have to monitor and report signals on drugs under additional monitoring.