Overview
EN ISO 27953-2:2011 - "Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR" - defines a standardized framework for international regulatory reporting and information sharing of individual case safety reports. Developed jointly under ISO/HL7 and adopted by CEN, this part specifies a common set of data elements and a messaging format for electronic transmission of ICSRs covering adverse drug reactions (ADRs), adverse events (AEs), infections and other incidents linked to human pharmaceutical products.
Key topics and requirements
- Common data elements: establishes the scope and purpose of a harmonized set of information fields required for ICSRs (patient, suspect product, reaction/event, outcome, reporter context).
- Messaging format: prescribes a standardized approach for packaging and transmitting ICSR data between stakeholders to support interoperability and regulatory exchange.
- Pharmacovigilance reporting rules: focuses on reporting requirements specific to human pharmaceutical products, ensuring consistent content for adverse event notifications.
- International regulatory alignment: supports cross-border exchange of safety information by using a consistent data model and transmission approach.
- Health informatics integration: intended to integrate with healthcare IT systems, electronic health records (EHRs) and national pharmacovigilance databases.
(ISO/HL7 and CEN adoption details indicate the standard’s role in pan‑European and international implementations.)
Practical applications
- Enables automated electronic reporting of ICSRs from pharmaceutical companies, healthcare providers and contract research organizations to national regulators and global safety databases.
- Improves data quality and consistency for signal detection, safety surveillance and regulatory decision-making.
- Facilitates interoperability between EHR systems, safety databases and pharmacovigilance tools, reducing manual data entry and reconciliation.
- Provides a foundation for building compliant pharmacovigilance workflows and automated case processing in safety management systems.
Who should use this standard
- Regulatory agencies and national pharmacovigilance centres
- Pharmaceutical manufacturers and pharmacovigilance departments
- Health informatics teams, EHR and safety system vendors
- Contract research organizations (CROs) and clinical trial safety teams
- IT implementers working on electronic ICSR transmission and interoperability
Related standards
- Other parts of the ISO/HL7 27953 series (related ICSR specifications and profiles)
- Health informatics and messaging standards (e.g., HL7 implementations) that enable electronic exchange of clinical and safety data
EN ISO 27953-2:2011 is essential for organizations seeking standardized, interoperable approaches to ICSR content and electronic reporting in pharmacovigilance, improving regulatory compliance and patient-safety information flow.
