EMA Pilot To Help Companies ‘Ease In’ To New EudraVigilance System
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.
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The pilot was launched to support a phased implementation of new EU requirements relating to monitoring and reporting drug safety information.
EU marketing authorization holders are unknowingly duplicating individual case safety reports in the revamped EudraVigilance database, a senior regulator warns.
The European Medicines Agency is revising its signal management guideline to clarify several terminologies and offer flexibility to help companies comply with their legal obligation to monitor the revamped EudraVigilance database. The biggest relief for the industry is that the new procedures in the guideline will be initially tested on a small number of products.