Revised guidance on ICSRs in the context of COVID-19

The European Medicines Agency (EMA) have updated their guidance on the validity and coding of Incident Case Safety Reports (ICSR) in the context of COVID-19 related terms.

The detailed guidance acknowledges that COVID-19 terms are available in the updated MedDRA version 23.0 onwards. It also notifies the release of COVID-19 standardised MedDRA queries (SMQ) with version 23.1

It provides recommendations relevant to the processing and submission of ICSRs associated with medicinal products used for the treatment or prevention of COVID-19. Organisations are reminded to comply with their legal obligations to report suspect adverse drug reactions in line with legislation Articles 107 and 107a of Directive 2001/83/EC and to adhere to the guidelines in GVP Module VI3, ICH E2B Guidelines4 and the current version of MedDRA term selection.

The guidance on coding outlines requirements for coding reactions/events, indications for use, relevant medical history, laboratory tests and investigations.

For more information click here.