Pharmaceutical companies often donate their products to those in dire need, but it hasn’t been especially clear how adverse events for donated products should be handled. In light of recent public health programs to fight neglected tropical diseases, the World Health Organization (WHO) asked the European Medicines Agency (EMA) to clarify the marketing authorization holder’s (MAH) obligation to report adverse events on medicines that are donated to areas outside of the European Union (EU).
According to EMA’s clarification, MAHs in the EU are, in fact, required to report serious adverse events via individual case safety reports (ICSRs) in EudraVigilance, and non-serious adverse events via summary tabulations and discussions in periodic safety update reports (PSURs).
