What is an Individual Case Safety Report (ICSR)?
Drug safety after approval is an important issue in the pharmaceutical industry. Individual Case Safety Reports (ICSRs) are documents which report adverse events in patients and can be used to identify risks and comply with regulations. As a core element of pharmacovigilance, ICSRs support global health decisions. Masuu Global provides end-to-end ICSR to assist businesses to meet the safety standards and global regulatory requirements.
Learning the Core Purpose of ICSRs in Pharmacovigilance.
ICSR is not a standard report per se, it is an essential element of safety information that pharmaceutical companies and governmental agencies use to determine whether a medication is safe or not.
Regardless of the source of derivation (e.g., patient reports, physician feedback), clinical trials, literature, or social media, every ICSR adds to:
- Signal detection (early identification of potential risks)
- Aggregate safety analysis (for Periodic Safety Update Reports and Risk Management Plans)
- Label change and legal intervention (e.g. warning or restriction)
FDA (US), EMA (EU), PMDA (Japan), and TGA (Australia) are regulatory agencies relying on ICSR data to make product safety decisions and ensure that people remain healthy.
Minimum Criteria for a Valid ICSR: What Makes a Report Complete
To be considered a valid ICSR, the report must contain the following four minimum criteria, as defined by ICH E2D/E2B(R3) guidelines:
- An Identifiable Patient – Information such as age, gender, or initials (without revealing identity).
- An Identifiable Reporter – A healthcare professional, consumer, or other individual who can be contacted for follow-up.
- A Suspect Drug or Product – Name, dosage, route, therapy dates, or at least partial product details.
- An Adverse Event or Reaction – A statement of the side effect, its severity and any clinical consequences.
Any case lacking at least one of these factors is said to be incomplete and may fail to pass regulations.
ICSR Reporting Timelines and Global Regulatory Requirements
Reporting of ICSR on time and correctly is a regulatory requirement of pharmacovigilance. Depending on the severity, anticipatability and cause of the adverse event, health authorities across the globe enforce effective reporting deadlines.
Regulations vary in the world, although the majority of them follow the ICH E2B(R3) standard. As an example, unexpected and serious adverse reactions typically necessitate expedited reporting, whereas non-serious adverse reactions can be incorporated within periodic safety updates.
All the regulatory agencies have their own deadline and filing formats:
- EMA (Europe) requires electronic reporting through
- FDA (USA) requires submissions through the FAERS system using Electronic Submissions Gateway (ESG).
- PMDA (Japan) has domestic and foreign case requirements.
- Health Canada, TGA (Australia) and others adopt ICH-like structures.
- Monitoring of these regional differences is key towards ensuring compliance.
Masuu Global provides end-to-end ICSR submission, which includes configuration of the gateway, timeline tracking in real-time and regional-based strategies on compliance. Masuu provides timely reporting in global markets with automation, centralized systems, and expert supervision, reducing regulatory risk and increasing inspection preparedness.