EN ISO 27953-2:2011
(Main)Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011)
General Information
- Abstract
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.
- Status
- Published
- Publication Date
- 30-Nov-2011
- Withdrawal Date
- 29-Jun-2012
- Technical Committee
- CEN/TC 251 - Medical informatics
- Drafting Committee
- CEN/TC 251/WG 1 - Information models
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 01-Dec-2011
- Completion Date
- 01-Dec-2011
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EN ISO 27953-2:2012 - PAZI: ISO na CD-romu! SIST standard je v PDF-obliki sestavljen samo iz CEN dokumenta in 3 strani ISO dokumenta. ISO/HL7 27953-2:2011 je v elektronski obliki, zip-file (html-oblika). ISO dokument je potrebno dodati na CD-romu. Število strani velja za celoten (skupaj z CEN-3 strani in ISO dokumentom-585 strani)
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.
Relations
- Refers
ISO/HL7 21731:2006 - Health informatics — HL7 version 3 — Reference information model — Release 1 - Effective Date
- 03-Jun-2026
- Effective Date
- 03-Jun-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 12-Feb-2026
Buy Documents
EN ISO 27953-2:2012 - PAZI: ISO na CD-romu! SIST standard je v PDF-obliki sestavljen samo iz CEN dokumenta in 3 strani ISO dokumenta. ISO/HL7 27953-2:2011 je v elektronski obliki, zip-file (html-oblika). ISO dokument je potrebno dodati na CD-romu. Število strani velja za celoten (skupaj z CEN-3 strani in ISO dokumentom-585 strani)
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Frequently Asked Questions
EN ISO 27953-2:2011 is a standard published by the European Committee for Standardization (CEN). Its full title is "Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011)". This standard covers: 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.
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.
EN ISO 27953-2:2011 is classified under the following ICS (International Classification for Standards) categories: 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 27953-2:2011 has the following relationships with other standards: It is inter standard links to ISO/HL7 21731:2006, ISO 21090:2011, ISO/TS 22224:2009, EN 1538:2010/FprA1, EN 16580:2015, EN ISO 18104:2014, ISO/HL7 27953-2:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 27953-2:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2012
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Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2:
Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011)
Medizinische Informatik - Pharmakovigilanz - Einzelfallbericht für unerwünschte
Arzneimittelwirkungen - Teil 2: Anforderungen für die Einzelfallberichte (ISO 27953-
2:2011)
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Ta slovenski standard je istoveten z: EN ISO 27953-2:2011
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 27953-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2011
ICS 35.240.80
English Version
Health informatics - Individual case safety reports (ICSRs) in
pharmacovigilance - Part 2: Human pharmaceutical reporting
requirements for ICSR (ISO 27953-2:2011)
Informatique de santé - Rapports de sécurité de cas Medizinische Informatik - Pharmakovigilanz -
individuel (ICSRs) en pharmacovigilance - Partie 2: Einzelfallbericht für unerwünschte Arzneimittelwirkungen -
Exigences pharmaceutiques humaines à rapporter pour un Teil 2: Anforderungen für die Einzelfallberichte (ISO 27953-
rapport de sécurité de cas individuel (ICSR) (ISO 27953- 2:2011)
2:2011)
This European Standard was approved by CEN on 12 November 2011.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
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© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 27953-2:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (
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