ICSR Reporting
Ensuring patient safety is the most important component of a pharmacovigilance (PV) system. Therefore, all pharmaceutical and biotechnology companies are required to identify, collect, and process Individual Case Safety Reports (ICSRs) in a systematic and robust manner, and report to regulatory authorities in accordance with strict requirements and timelines.
ProPharma recognizes the critical nature of accurate and on-time submissions to regulatory authorities, Institutional Review Boards (IRBs), Ethics Committees (ECs), and investigator sites.
We perform ICSR submissions including MedWatch, CIOMS I, E2B(R2), and E2B(R3) reports for various product types including approved and non-approved drugs, biologics, devices, vaccines, dietary supplements, cosmetics, homeopathic products, and natural health products.
ProPharma's ICSR Workflow
ICSRs are exchanged with clients and Sponsors for review and comment before the final submission, if requested. Clients and Sponsors also maintain oversight of case processing and reporting activities ahead of submission via Case Explorer, a read-only application that allows for real-time database queries and review of information within individual cases.
Clients and Sponsors who wish to maintain oversight of case processing within the safety database itself may also do so via read-only access as part of individual user implementation and security procedures.
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ICSR Compliance
Each month, compliance metrics are generated from submission records in the safety database for all pharmacovigilance and clinical safety programs and shared with all interested clients.
ProPharma is proud to post a greater than 99% compliance rate, successfully submitting over 2,000 ICSRs per month to regulatory authorities and business partners on behalf of post-marketing pharmacovigilance clients and clinical safety Sponsors.
Frequently Asked Questions about ICSRs
What is an Individual Case Safety Report (ICSR)?
An Individual Case Safety Report (ICSR) is a document that captures information needed to report one or more suspected adverse reactions to a medical product that occur in a single patient at a specific point in time. ICSRs are used to support the monitoring and evaluation of the safety and effectiveness of medical products, such as drugs, biologics, vaccines, devices, and tobacco products. ICSRs are also used to identify potential signals of new or emerging safety issues, or changes in the known safety profile of a product.
What are the FDA requirements for an ICSR?
The FDA requirements for an ICSR are as follows:
- An ICSR should include the following information:
- Patient information, such as patient identification code and age at the time of adverse drug experience.
- Adverse event information, such as outcome attributed to adverse drug event.
- Suspect medical product information, such as name.
- Initial reporter information, such as name, address, and telephone number.
- Applicant information, as defined in section 760 (b) of the FD&C Act.
- Submitted electronically using the ISO ICSR/ ICH E2B (R2/R3) format and related ISO standard terminology for pharmaceutical form and route of administration.
- Clinical trial Suspected Unexpected Serious Adverse Reactions (SUSARs) are submitted within 7 days for fatal/life threatening reports and 15 days for all other serious reports.
- Post marketed serious ICRS are submitted within 15 days and within 90 days for non-serious EU ICSRs, according to the regulatory reporting guidelines.
- Submitted to the FDA Adverse Event Reporting System (FAERS) or to the appropriate FDA center, depending on the product type and submission method.
- An ICSR should follow the guidance documents, implementation guides, specifications, schema files, and validation procedures published by the FDA for electronic submission of ICSRs
What are the MHRA/EMA requirements for an ICSR?
The EMA requirements for an ICSR are as follows:
- Per the GVP module VI requirements this must include an identifiable reporter, an identifiable patient, adverse reaction information, and a suspect medicinal product.
- Should be submitted electronically using the ISO ICSR/ICH E2B (R3) format and related ISO standard terminology for pharmaceutical form and route of administration.
- Clinical trial Suspected Unexpected Serious Adverse Reactions (SUSARs) are submitted within 7 days for fatal/life threatening reports and 15 days for all other serious reports.
- Post marketed serious ICRS are submitted within 15 days and within 90 days for non-serious ICSRs, according to the regulatory reporting guidelines.
- Submitted to the applicable regulatory authority (e.g. EudraVigilance database or MHRA ICSR portal)where the suspected adverse reaction occurred, depending on the marketing authorization procedure and the origin of the ICSR.
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