The short version
What teams need to understand
- ICSRs must be reported to regulatory authorities within defined timelines.
- Cases must be classified correctly to determine reporting requirements.
- Serious unexpected cases must be reported within expedited timelines.
- Reporting timelines must be calculated from day zero.
- Submissions must be accurate, complete, and compliant with regulatory formats.
- Inspection-ready evidence should demonstrate timely and correct reporting of ICSRs.
Regulatory expectation
What regulators expect
Each expectation should be supported by controlled documentation, traceable records, clear ownership, and evidence that the process works in practice.
- ICSRs must be reported within regulatory timelines.
- Day zero must be used to calculate reporting deadlines.
- Case classification must determine reporting requirements.
- Submission must follow regulatory formats and requirements.
- Late submissions must be documented and investigated.
Why it matters
What this means in practice
Inspectors assess whether pharmacovigilance systems report ICSRs within required timelines and according to regulatory requirements. They typically review case classification, reporting decisions, submission records, and evidence of compliance with 7-day and 15-day timelines.
Questions this page answers
Inspection evidence
Evidence teams should be able to show
ICSR Submission Records
- E2B submission records
- CIOMS or MedWatch forms
- Submission timestamps
- Acknowledgements from regulatory systems
Reporting Timeline Tracking
- Calculation of day zero
- Due date tracking for each case
- Documentation of reporting timelines
- Evidence of on-time submission
Case Classification Documentation
- Serious vs non-serious classification
- Expected vs unexpected assessment
- Determination of expedited reporting requirement
- Documentation supporting classification decisions
Regulatory Submission Systems
- Safety database submission logs (e.g. Argus)
- EudraVigilance submissions
- FDA ESG submissions
- Local authority reporting confirmations
Regulatory Basis (Primary Sources)
- GVP Module VI - requirements for ICSR reporting timelines
- ICH E2D - expedited reporting requirements
- ICH E2A - clinical trial safety reporting timelines
- MHRA GPvP guidance - reporting obligations
- FDA 21 CFR 314.80 and 600.80 - postmarketing reporting timelines
Typical Inspection Questions (What Inspectors Ask)
- How do you determine reporting timelines?
- Show me submission records for this case.
- How do you calculate day zero?
- What happens if a case is submitted late?
- How do you ensure compliance with 7-day and 15-day reporting?
Common failure patterns
What good looks like
- Accurate classification of cases for reporting.
- Correct calculation of reporting timelines.
- Timely submission of all ICSRs.
- Complete and traceable submission records.
- Documented investigation of any late cases.
How teams operationalise it
- Define reporting timelines within PV SOPs.
- Ensure day zero is consistently applied.
- Implement systems to track submission deadlines.
- Validate case classification before reporting.
- Monitor compliance with reporting timelines.
- Investigate and document any late submissions.
From expectation to working control
Find the documentation that supports this work
Review the related toolkit to understand its purpose, included files, and how it supports this regulatory expectation.
Frequently asked questions
What are the 7-day and 15-day reporting rules?
Serious unexpected cases must typically be reported within 15 days, while fatal or life-threatening cases may require reporting within 7 days.
What determines whether an ICSR must be reported within 7 days or 15 days?
Fatal or life-threatening serious unexpected cases must typically be reported within 7 days, while other serious unexpected cases are reported within 15 days. The classification depends on seriousness, expectedness, and regulatory requirements, with timelines calculated from day zero.
What is day zero in reporting timelines?
Day zero is the date when a valid ICSR is first received and triggers regulatory reporting timelines.
What is expedited reporting?
Expedited reporting refers to the rapid submission of serious and unexpected adverse events within defined timelines.
Do inspectors review submission timelines?
Yes. Inspectors frequently review submission records to confirm compliance with reporting timelines.
What happens if reporting is late?
Late reporting may result in inspection findings and requires investigation and CAPA.
How do regulators receive ICSRs?
ICSRs are typically submitted electronically via E2B format through systems such as EudraVigilance or FDA ESG.
Source boundary
Regulatory sources
These primary sources inform this structured interpretation. Always confirm current requirements against the original source and the requirements applicable to your organisation, product, and jurisdiction.
European Medicines Agency (EMA)
Guideline on good pharmacovigilance practices (GVP) - Module VI
View source
FDA
Postmarketing Safety Reporting
View source
ICH
Clinical Safety Data Management (E2A)
View sourcePost-Approval Safety Data Management (E2D)
View source
MHRA
Good Pharmacovigilance Practice (GPvP)
View source