EMA’s Management Board agreed to the mandatory use of a consistent international format, the ISO ICSR format, for reporting individual cases of suspected side effects in patients across the world. The use of the new international standard will become mandatory as of 30 June 2022 for all reporting to EudraVigilance, the European database of suspected side effects with medicines authorised in the European Economic Area (EEA).
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.
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