Regulatory timelines:
The timeline for submitting an ICSR depends on country-specific regulatory requirements.
The regulatory timeline starts from the Initial receipt date- “Day 0” of the ICSR. Calendar days are considered for calculating the due date for regulatory submission irrespective of weekends and holidays.
The ICSR timelines followed by most of developed country’s health authorities globally are depicted here:
- Serious Unexpected Suspected Adverse Reaction (SUSAR): ICSRs containing the SUSAR events are considered of high importance and are prioritized for submission to regulatory authority before due date.
Based on seriousness criteria, there are two timelines for SUSAR ICSRs
- 7-Day Timeline: Any SUSAR ICSR with either “Death” or “Life Threatening” as seriousness criteria in the case should be submitted to regulatory authority within 7-day timeline period.
- 15-Day Timeline: Any SUSAR ICSR with the other seriousness criteria (other than the death or life-threatening) should be submitted to regulatory authority within 15-day timeline period.
2. Non serious cases: Non serious ICSRs (cases with no serious adverse drug events or reactions) are submitted to regulatory authority within 90-day timeline period.
Regulatory Guidelines
Each national health/regulatory body has their own requirements for handling ICSR data, regulatory timelines etc.,
The most commonly followed regulations are listed here:
2. EMA-GVP-VI