Posted by Michael Wonder on 23 Sep 2020
How incidents with medicines are managed in the EU – a ten year analysis
23 September 2020 - The EU medicines network is supported by a robust regulatory framework with defined processes and clear responsibilities in place to handle public health incidents, according to a 10 year analysis of the European Union incident management plan (EU-IMP) published in the journal Pharmacoepidemiology and Drug Safety.
EMA, in collaboration with the Heads of Medicines Agencies 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.
