Which statements best describes what is subject to expedited reporting for adverse drug reactions?

• A. Only fatal or life-threatening ADRs are reportable.
• B. Any ADR must be reported within 7 days.
• C. All ADRs that are serious and unexpected with the source specified and causality assessment required.
• D. Only ADRs that are new safety signals.

Answer: (C)

Expedited reporting targets events that are both serious and unexpected and requires clear documentation of where the information came from and an assessment of whether the drug likely caused the event. This combination ensures timely detection of new or changing safety risks and provides regulators with the details needed to evaluate causality and the reliability of the report.

The best description is that all adverse drug reactions that are serious and unexpected, with the source of the report specified and a causality assessment required, fit the expedited reporting criteria. This captures the essential elements: seriousness, unexpectedness, traceable source, and an assessment of the drug–event relationship.

Why the other statements don’t fit: reporting isn’t limited to fatal or life-threatening events, since serious but non-fatal events are also reportable if unexpected. Expedited reporting isn’t required for every ADR within a universal seven-day window; timelines depend on the event’s seriousness and regulatory rules, and not all ADRs are handled as expedited reports. And it isn’t limited to new safety signals; ongoing or previously known risks can also be reported rapidly if they’re serious and unexpected.