FDA updates set the stage for broader use of harmonized standards for safety reporting


Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. This week, the FDA announced it is finally ready to start accepting adverse event submissions in ICH E2B(R3) format and that the countdown to mandatory compliance with these requirements has begun. The agency also issued three updated guidances to help sponsors prepare.

The International Council for Harmonization’s (ICH) E2 guidelines were created to facilitate the timely and standardized exchange of information from sponsors to regulators on serious and urgent safety issues arising from the use of biopharmaceutical products.

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