In pharmacovigilance, adverse drug reaction (ADR) report gathering and analysis is critical to the overall protection of the health of the population. Another essential part of this initiative is the Individual Case Safety Report (ICSR) a harmonic framework of storing and reporting the suspected adverse reactions of medicinal products.
Masuu Global focus is to offer a complete ICSR management solution, which means regulatory compliance, data correctness and proactive patient safety.
What is an ICSR?
The Individual Case Safety Report (ICSR) is a comprehensive report, which includes facts on a single patient, a suspected adverse event, drug (or drugs), and on clinical or demographic attributes. These reports are a part of the pharmacovigilance compliance by a firm and are submitted to the regulatory authorities and are required to critical role in:
- Monitoring the benefit-risk profile of a product
- Detecting new safety signals
- Promoting the product labeling and warning change
- Adherence to local, and global regulatory compliance guidelines
Case Validity:
Only valid ICSRs qualify for reporting, All reports of suspected adverse reactions should therefore be validated before reporting them to the competent authorities.
- One or more identifiable reporter
- One single identifiable patient
- One or more suspected substance
- One or more suspected adverse reaction
Sources of ICSRs
ICSRs can originate from multiple sources, including:- The origin of ICSRs can be of various sources such as:
- Unprompted reports made by healthcare professionals, patients or caregivers
- Post marketing research and the clinical trials
- Scientific literature
- Regulatory authority communications
- Social media or other digital platforms (in some jurisdictions)
Each ICSR should be gathered, evaluated, coded (MedDRA), inserted into safety databases, and reported to relevant regulatory authority within specific timeframes.
Regulatory Expectations
ICSRs must be reported using regulatory agencies like European Medicines Agency (EMA), U.S. FDA, Health Canada and MHRA. Submission timelines vary:- 30 days for other serious adverse events and for initiating an investigation;
- In periodical safety reports (e.g., PSURs) of non-expedited cases
- The requirement that the agencies may have is that the transmission must be through electronic systems like EudraVigilance (EU), FAERS (USA) or VigiBase (WHO).
Challenges in ICSR Management
ICSR management needs resources and requires:- Trained pharmacovigilance professionals
- Advanced safety database systems
- Up-to-date regulatory knowledge
- Uniformed MedDRA coding and writing of narratives
- Inventions on time as per international laws
- Inability to comply with these standards may lead to inspection reports, product recalls, or reputational hazard.
How Masuu Global facilitates ICSR Management
- Masuu Global offers end to end ICSR lifecycle support including:
- All-source case intake and triage Case intake and triage
- Seriousness assessments and review by medical matters
- MedDRA coding and causality assessments
- Narrative writing and quality control
- Compliance through E2B-based formats in submission of health authorities
- Reconciliation and tracking continuous compliance
- We apply the validated safety databases, refer to GVP rules and make your ICSR process completely compliant and audit-ready.
A key element of an acceptable and successful pharmacovigilance system would be ICSR management. Harmless management of case reports is not only a regulation, but it is a safety advantage and an attribute when it comes to consumer assurance of your product.
Masuu Global is your pharmacovigilance partner of choice, providing a well-rounded, scalable, expert-led ICSR management solution that leaves you free to be innovative and focus on your business, whilst we look after patient safety.
Contact us now to discuss how to make your pharmacovigilance processes both efficient and effective.
