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

New Standard Offers Improved Quality Of Data Collected

 
• By Vibha Sharma

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 side-effects of medicines authorized in the European Economic Area. In...

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