ISO/HL7 27953-2:2011

Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR

ISO 27593-2:2011 seeks to create a standardized framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that can occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination.

Informatique de santé — Rapports de sécurité de cas individuel (ICSRs) en pharmacovigilance — Partie 2: Exigences pharmaceutiques humaines à rapporter pour un rapport de sécurité de cas individuel (ICSR)

L'ISO 27953-2:2011 vise à établir un cadre de travail international pour les déclarations réglementaires internationales et le partage d'informations en fournissant un ensemble commun d'éléments de données et un format de messagerie pour la transmission des ICSR relatifs aux effets indésirables des médicaments (EIM), aux effets indésirables (EI), aux infections et incidents qui peuvent se produire lors de l'administration d'un ou de plusieurs produits pharmaceutiques à usage humain à un patient, indépendamment de la source et de la destination de ces informations.

General Information

• Status: Published
• Publication Date: 20-Nov-2011
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 6 - Pharmacy and medicines business
• Current Stage: 9093 - International Standard confirmed
• Start Date: 19-Jul-2022
• Completion Date: 30-Oct-2025

Relations

• Consolidates: ISO 17115:2007 - Health informatics - Vocabulary of compositional terminological systems
• Effective Date: 06-Jun-2022

Overview

ISO/HL7 27953-2:2011 establishes a harmonized framework for electronic Individual Case Safety Reports (ICSRs) in pharmacovigilance for human pharmaceutical reporting. Developed jointly by ISO and HL7, Part 2 of the 27953 series defines a common set of data elements and a messaging format to support international regulatory reporting and secure information sharing of adverse drug reactions (ADR), adverse events (AE), infections and other incidents related to the administration of one or more human medicinal products.

This standard facilitates consistent capture and transmission of safety case information regardless of source or destination, improving interoperability between healthcare providers, manufacturers, national competent authorities and global safety databases.

Key Topics and Requirements

• Common data model: A standardized set of ICSR data elements to represent cases consistently across organizations and jurisdictions.
• Messaging format: Definitions for electronic transmission of ICSRs to enable automated exchange between systems.
• Coverage: Reporting requirements applicable to ADRs, AEs, infections and related incidents involving human pharmaceutical products.
• Interoperability focus: Alignment with health informatics practices to support integration with clinical systems, safety databases and regulatory workflows.
• Regulatory reporting orientation: Enables submission-ready ICSR content to meet national and international pharmacovigilance obligations.

Note: ISO/HL7 27953-2 specifies the structure and content scope for ICSR exchanges rather than prescribing a particular software implementation.

Practical Applications and Users

Who uses ISO/HL7 27953-2:

• Pharmacovigilance teams in pharmaceutical companies for preparing and transmitting standardized ICSRs.
• Regulatory authorities and public health agencies for intake, review and cross-jurisdictional exchange of safety reports.
• Health IT vendors and EHR/EPR system integrators implementing electronic ADR/AE reporting modules.
• Hospitals, clinics and clinical trial sponsors that need to report safety events in a compliant, machine-readable format.

Practical benefits:

• Reduces ambiguity and manual rework in safety reporting.
• Streamlines automated ingestion of case reports into signal detection and case management systems.
• Improves timeliness and quality of data exchanged between manufacturers, regulators and care providers.

Related Standards

• Other parts of the ISO/HL7 27953 series (ICSR architecture and related guidance).
• HL7-related implementation frameworks and clinical data exchange standards used in safety-reporting workflows.

Keywords: ISO/HL7 27953-2, ICSR, pharmacovigilance standard, adverse drug reaction reporting, electronic safety report, ADR reporting, human pharmaceutical reporting.

Standards Content (Sample)

INTERNATIONAL ISO/HL7
STANDARD 27953-2
First edition
2011-12-01
Corrected version
2012-10-15
Health informatics — Individual case
safety reports (ICSRs) in
pharmacovigilance —
Part 2:
Human pharmaceutical reporting
requirements for ICSR
Informatique de santé — Rapports de sécurité de cas individuel
(ICSRs) en pharmacovigilance —
Partie 2: Exigences pharmaceutiques humaines à rapporter pour un
rapport de sécurité de cas individuel (ICSR)

Reference number
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NORME ISO/HL7
INTERNATIONALE 27953-2
Première édition
2011-12-01
Informatique de santé — Rapports de
sécurité de cas individuel (ICSRs) en
pharmacovigilance —
Partie 2:
Exigences pharmaceutiques humaines à
rapporter pour un rapport de sécurité de
cas individuel (ICSR)
Health informatics — Individual case safety reports (ICSRs) in
pharmacovigilance —
Part 2: Human pharmaceutical reporting requirements for ICSR

Numéro de référence
©
ISO/HL7 2011
Le présent CD-ROM contient la publication ISO/HL7 27953-2:2011 au format HTML.

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© ISO et Health Level Seven International 2011.
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Tel. + 41 22 749 01 11 Tel. [phone]
Fax + 41 22 749 09 47 Fax [phone]
E-mail [e-mail] E-mail [e-mail]
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