EMA: Signal Management Improved After Pharmacovigilance Reforms

Regulatory NewsRegulatory News | 11 December 2019 |  By 

The European Medicines Agency (EMA) on Wednesday touted the results of a six-year review that show improvements to signal management for medicines within the EU following pharmacovigilance reforms in 2012.
In 2010 and 2012, the EU introduced new directives and regulations amending its pharmacovigilance requirements, which came into force under the new pharmacovigilance legislation.
“In the first six years since the implementation of the 2012 EU pharmacovigilance legislation, the EU network has demonstrated its ability to reliably detect, assess and manage safety signals for medicines,” EMA said.
According to the review, more than 26,000 potential signals were reviewed by the EU network during the first six-year mandate of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), resulting in 563 validated signals, of which 465 were confirmed. During that time, the PRAC held nearly 800 initial and follow-up discussions related to 453 of the confirmed signals, with the remaining 12 held in the month after the cutoff for the review.
“The reduction from 26,000 to 563 validated signals is based on the well-established signal validation approaches, including whether something is already labeled in the product information,” the authors of the review wrote.
EMA notes that more than half of PRAC’s recommendations related to the signals it reviewed led to changes in product information for the drug the signal pertained to.
EMA also said that some of the risk minimization measures were “made in as few as five days of a signal being confirmed,” with a median review time of five months.
EMA, Review


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