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.