EU Makes ISO Format Mandatory For Side-Effect Reporting From June 2022

New Standard Offers Improved Quality Of Data Collected

16 Jan 2020

Based on the operational experience gained using the new international standard for reporting suspected adverse reactions in EudraVigilance, the EU has decided to set a date for its mandatory use.

Side effects — Mandatory Use Of ISO ICSR standard will improve patient safety • Source: Shutterstock

The European Medicines Agency is making it mandatory for drug companies to use a new consistent international standard – the International Organization for Standardization’s individual case safety report (ICSR) format – for reporting individual cases of suspected side-effects in patients as of 30 June 2022.

The use of the ISO ICSR format will become mandatory for all reporting to EudraVigilance, the European database of suspected...