From adverse event intake to electronic regulatory submission — complete Individual Case Safety Report management handled by our trained drug safety team.
Discuss Your Case Processing NeedsAn Individual Case Safety Report (ICSR) is the cornerstone of pharmacovigilance. It is a structured report that captures all relevant information about a single adverse event associated with a medicinal product — including patient demographics, drug details, event description, clinical outcome, and causality assessment.
ICSRs are submitted by Marketing Authorization Holders to national regulators (CDSCO/PvPI in India), and to international regulators such as EMA, FDA and MHRA.
Regulatory Basis (India): NDCT Rules 2019, Rule 37 mandates all MAHs to report serious adverse events (SAEs) within 15 calendar days and all non-serious adverse events within 90 calendar days to CDSCO/PvPI. Fatal or life-threatening SUSARs must be reported within 7 days.
We receive adverse event reports from all sources — spontaneous reports, clinical trials, literature, company-sponsored studies, consumer reports, and health authority-mandated surveillance programmes.
Each case is assessed for seriousness, expectedness and completeness. Duplicate case identification is performed using patient demographics, product and event matching algorithms before data entry.
Our MedDRA-licensed team codes all adverse event terms and indications using the MedDRA dictionary, correctly mapping at LLT, PT, HLT, HLGT and SOC levels as required.
Medical review by experienced safety physicians applying WHO-UMC and Naranjo causality criteria. Labelling assessment against reference documents (SmPC, IB, SPL).
Generation of ICH E2B(R3)-compliant XML files for electronic submission. Direct AS2/gateway transmission to EMA (EudraVigilance), US FDA (MedWatch/FAERS), MHRA and PvPI/CDSCO.
Structured follow-up queries sent to reporters. All follow-up information incorporated, with versioned reports reflecting updates to the case record.
| ICSR Type | India (CDSCO) | EU (EMA) | US (FDA) |
|---|---|---|---|
| Fatal / Life-threatening SUSAR | 7 Cal. Days | 7 Cal. Days | 7 Cal. Days |
| Non-fatal / Non-LT SUSAR | 15 Calendar Days | 15 Calendar Days | 15 Calendar Days |
| Serious AE (post-marketing) | 15 Calendar Days | 15 Calendar Days | 15 Calendar Days |
| Non-serious AE (post-marketing) | 90 Calendar Days | 90 Calendar Days | 90 Calendar Days |
An Adverse Event (AE) is any untoward medical occurrence associated with a medicinal product. A Serious Adverse Event (SAE) meets at least one seriousness criterion: death, life-threatening condition, hospitalisation, persistent/significant disability, congenital anomaly, or a medically important event. SAEs have shorter mandatory reporting timelines.
MedDRA (Medical Dictionary for Regulatory Activities) is the international standard for medical terminology used in regulatory submissions. The IPC PV Guidance V2.0 has replaced ICD coding with MedDRA for all ICSR submissions in India. Correct MedDRA coding ensures accurate signal detection and regulatory compliance.
Yes. Auriga processes both Suspected Unexpected Serious Adverse Reactions (SUSARs) from clinical trials and post-marketing individual case safety reports.
Contact our PV team for a free 30-minute consultation or a live demonstration of the Auriga Safety System.
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