Signal management

EMA: improved signal management after pharmacovigilance reforms

Posted on December 11, 2019 | By Michael Mezher

The European Medicines Agency (EMA) on Wednesday touted the results of a six-year review that show improvements in the handling of signals for medicines within the EU following pharmacovigilance reforms in 2012.

In 2010 and 2012, the EU introduced new directives and regulations modifying its pharmacovigilance requirements, which came into force as part of 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 medicine safety signals,” said the EMA.

According to the review, more than 26,000 potential signals were reviewed by the EU network during the first six-year term of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which resulted in 563 validated signals, of which 465 were confirmed. During this period, the PRAC held nearly 800 initial and follow-up discussions relating to 453 of the confirmed signals, with the remaining 12 taking place within a month of the review deadline.

“The reduction from 26,000 to 563 validated signals is based on well-established signal validation approaches, including whether something is already labeled in the product information,” the review authors wrote.

The EMA notes that more than half of the PRAC recommendations related to the signals it reviewed resulted in changes to the product information for the medicine to which the signal related.

The EMA also said some of the risk minimization measures were “taken in as little as five days after a signal was confirmed”, with a median review time of five months.

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