How incidents with medicines are managed in the EU – a ten-year analysis
EMA, in collaboration with the Heads of Medicines Agencies (HMA) and the European Commission, established the EU-IMP in 2009 to enable rapid and effective actions across the EU in case of an event or new information on medicines authorised in the EU with a potential serious impact on public health. Such incidents can affect the safety, quality, efficacy or availability of a medicinal product and causes may include the product’s safety profile, manufacturing compliance or supply chain issues.
When an incident is suspected, a group of experts from EMA and its scientific committees, the European Commission and the national competent authorities, called the Incident Review Network (IRN), convenes within the shortest possible time to assess the potential public health impact and recommend the appropriate regulatory pathway and the most appropriate communications.
During the first ten years of operation of the EU-IMP, a total of 78 incidents were managed through the IRN. Of these, 70% were triggered by information that came to EMA from national competent authorities, followed by information from marketing authorisation holders (17%).
During the observation period, more than half of the issues addressed concerned the safety of medicines, while quality and non-compliance with good manufacturing practices accounted for over one third of issues.
Regarding the final outcomes of the incidents managed through the IRN, almost half resulted in a variation to the marketing authorisation and/or risk minimisation measures of the concerned medicine. 22% led to no change to the marketing authorisation, 10% led to the suspension and 9% to the revocation of a medicine’s marketing authorisation.
The analysis also highlights that the implementation of the revised pharmacovigilance legislation in 2012 has offered robust regulatory instruments and has established clear roles and responsibilities to directly manage most safety issues without the need to go through the IRN mechanism.
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