Adverse Event Seriousness and Reporting Timeline Determiner
Answer a few questions about an adverse event and learn whether it is Serious, whether it is expedited, and the resulting reporting deadline in Kenya. Built for pharmacovigilance and QA teams that need a fast, defensible triage.
Tick any that apply to this case.
Leave all unticked if none of the above apply (non-serious).
Result
Seriousness verdict
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Expedited
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Reporting deadline
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Rationale
Fill in the questions and select Determine to see the guidance.
Unexpected serious reactions are the priority for expedited local reporting. Expectedness and the domestic or foreign status shape what a marketing authorisation holder submits locally.
Disclaimer: This tool determines seriousness and the resulting reporting clock as a guide only. Always follow your pharmacovigilance agreement and the current PPB requirements.
Adverse event seriousness and reporting: FAQ
What makes an adverse event serious?
An adverse event is serious if it meets any one of the standard criteria: it resulted in death, was life-threatening, required or prolonged hospitalisation, caused persistent or significant disability or incapacity, was a congenital anomaly or birth defect, or was another medically important condition. Ticking any single criterion is enough to make the case serious.
What is the reporting timeline for a serious ADR in Kenya?
These are indicative calendar-day timelines aligned with ICH practice. A serious reaction that resulted in death or was life-threatening is reported within 7 calendar days for the initial report, with the full follow-up report within a further 8 calendar days, so 15 in total. Other serious reactions are reported within 15 calendar days. Non-serious reactions are submitted periodically in the aggregate or PSUR cycle rather than on an expedited clock.
What is the difference between expedited and periodic reporting?
Expedited reporting means an individual case is submitted quickly against a fixed calendar-day deadline because it is serious. Periodic reporting means non-serious cases are collected and submitted together in the aggregate safety reporting cycle, such as a Periodic Safety Update Report, rather than one at a time.
How do expectedness and domestic or foreign status affect reporting?
Seriousness drives the expedited clock, but expectedness and where the case occurred shape what a marketing authorisation holder submits locally. Unexpected serious reactions, those not listed in the approved product information, are the priority for expedited local reporting. Confirm the exact local obligations against your pharmacovigilance agreement and the current PPB requirements.
Need your pharmacovigilance case handling audit-ready?
We set up case intake, seriousness assessment, and expedited reporting workflows so your safety reports meet the PPB deadlines and hold up in an inspection.