The European Medicines Agency’s (EMA) management board has agreed to make the International Organisation for Standardisation’s (ISO) individual case safety report (ICSR) format mandatory for suspected adverse drug reaction (ADR) reporting to EudraVigilance.
The ISO format is based on the International Council of Harmonisation’s (ICH) E2B (R3) modalities for the reporting of suspected ADRs in ICSRs. This format will improve the quality of data collected, as well as the ability to search and evaluate this data. This should support regulatory authorities in detecting and addressing safety issues. This format will also offer more robust data protection for patients.
Currently, ICSRs in the previous ICH E2B (R2) format are accepted in EudraVigilance, but must be converted to the newer format when received. The problem with this is that critical information found in case narratives may not be populated into the dedicated data fields, limiting the data analysis by regulators.