The number of links between drugs and adverse events identified by the European Medicines Agency fell by 17% in 2014. However, the EMA does not believe that the drop is a sign of an inherent increase in drugs safety.
In 2014, EudraVigilance accounted for almost 87% of potential AE signals identified by EMA — down from 91% the year before. The 2,030 signals identified in EudraVigilance last year is the second smallest total in its five-year history.
EMA is unconcerned about the dip, believing that it reflects increased familiarity with EudraVigilance and technical improvements to the system, “notably the inclusion of hyperlinks to line listings in the EudraVigilance Data Analysis System.”
EMA’s Pharmacovigilance Inspectors Working Group also gave an update on some of the documents it has been working on. These include a checklist of key questions to guide pharmacovigilance inspections of manufacturers of pandemic flu vaccines.
EMA also gave some additional detail concerning what happens when concerns are raised during the evaluation of pharmacovigilance data. If the concerns are serious enough to consider suspending or revoking a marketing authorization, an urgent union procedure is initiated.
EMA has updated a question and answer document about this process with details of what companies can expect and how they can contribute to the review. The regulator also updated its Q&A covering Article 31 referrals, the process initiated when concerns raised are less severe.
Read more [here].
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