EMA to Use ISO International Format for Reporting Individual Side Effects

The European Medicines Agency said that it will begin requiring the use of the International Organization for Standardization (ISO)’s individual case safety report (ICSR) format for individual cases of suspected patient side effects.

Starting in June 2022, side effects will need to be submitted to the EudraVigilance safety monitoring system using the ICSR format, which provides a common set of data points for adverse drug reactions, adverse events, infections and incidents that can occur from drug administration.

The new format will generate higher quality, easier-to-analyze data that “will better support regulatory authorities and companies to detect and address safety issues with medicines and therefore protect patients,” the agency said.