Analysis proves EU safety system robust

The European Medicines Agency (EMA) has produced a report into its incident management plan (EU-IMP) showing it has functioned effectively in the ten years since its creation.

EU-IMP allows for reporting of issues with medicines to the Incident Review Network (IRN), a group of EMA experts, committee members, and national representatives. EMA said:

“During the first ten years of operation of the EU-IMP, a total of 78 incidents were managed through the IRN…

“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.”

Read the full report for more information on EMA’s safety mechanisms.

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Published on 24. September 2020 in News, News EU, Press Release