EMA starts reporting adverse events

Published: 15-Oct-2013
Regulatory

Some could potentially be caused by a medicine, says the Agency


The European Medicines Agency (EMA) has released the first of regular documents highlighting potential safety concerns related to licensed medicines. These will note so-called ‘safety signals’ discussed at meetings of EMA’s pharmacovigilance risk assessment committee (PRAC). Such signals, said EMA, are 'information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation'.

EMA stressed that these may not prove that a medicine is to blame – problems could be caused by another illness or additional medicine. But they do need to be investigated to check a potential 'causal relationship between the medicine and the reported adverse event', said the Agency.

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