Individual Case Safety Reports

Description:  The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products. 

ICSR Release 2 was completed December 2011 as an SDO Joint Initiative Project between the International Standards Organization (ISO), the European Committee for Standardization (CEN) and HL7.  Information about the SDO Joint Initiative can be found at: http://www.jointinitiativecouncil.org/. The ICSR specification, ISO/HL7 27953 is a multi-part standard created to consolidate work efforts in ISO and HL7 as follows:

1. ISO new work item proposal N545: Health informatics - Pharmacovigilance - Structure and data elements of individual case safety report (reclassified as ISO 27953);

2. Health Level Seven (HL7) Individual Case Safety Report (ICSR) Release 1, Normative Standard;

3. HL7 ICSR Release 2, Draft Standard for Trial Use (DSTU)ISO/HL7 27953-1 (Part 1) is designed to address areas of overlap across the work items and form a messaging framework reference. This framework can be applied to support data exchange requirements described in the many different use cases presented as storyboards in this International Standard. This framework allows for future development work to be carried out so that additional use cases that are not currently addressed in this edition can be added in the future as new parts to this International Standard.

ISO/HL7 27953-2 (Part 2) is designed at a conformance profile for Part 1 for use by the International Conference on Harmonisation (ICH) revised guideline E2B(R3): Data Elements for Transmission of Individual Case Safety Reports. The ICH requirements have been further extended to take into account additional international requirements. Use of ISO 27953-2 is dependent upon the related ISO vocabulary harmonization work Identification of Medicinal Products (IDMP), which is a suite of related standards used to uniquely identify regulated products through the product lifecycle (premarket to postmarket). 

Individual Case Safety Report Resources: FDA implementation of the Individual Case Safety Report (ICSR) Standard varies by product type. Implementers should contact the receiving program (e.g., FAERS, VAERS, eMDR, CVM) prior to submission of ICSRs to the Agency. Links to applicable ICSR guidance documents are provided as a resource to clarify ICSR content and format requirements for electronic ICSR submissions to FDA.

• Biologics and Vaccines Adverse Events
• Food Adverse Events
• Human Drugs Adverse Events
• Medical Device Adverse Events
• Veterinary Adverse Events
• Tobacco Adverse Events 

 

ICSR Guidance Documents, Implementation Guides, Specifications, Schema Files, and Validation Procedures  

• Schema Files and Validation Procedures
  • Schema Files 

• Human Drugs, Biologics and Vaccines
  • Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
  • E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility       
  • Guidance for Industry Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed without an Approved Application              
  • Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Postmarketing Individual Case Safety Reports              
  • Guidance for Industry: Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers              
  • Vaccine Adverse Event Reporting System (VAERS) Electronic Submissions  

• Medical Devices
  • Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff 

• Veterinary Products             
  • Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine 

• Food and Cosmetics              
  • Currently the Foods program is not collecting adverse event reports using the ICSR format. Please refer to the Safety Reporting Portal for further information. 

• Tobacvo Products              
  • Currently the Tobacco program is not collecting adverse event reports using the ICSR format. Please refer to the Safety Reporting Portal for further information.  

ICSR Dockets

• FDA-2008-N-0334 Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
• FDA-2001-D-0067 Providing Regulatory Submissions in Electronic Format
• FDA-1992-S-0039 Public Docket to Provide Information on Submissions the Agency is Prepared to Accept Electronically 

Contact Information 

 

Questions regarding ICSR submissions should be directed to:

• Human Drugs: faersesub@fda.hhs.gov
• Biologics and Vaccines: CBERICSRSubmissions@fda.hhs.gov
• Veterinary Products: CVMAESupport@fda.hhs.gov 
• Medical Devices: emdr@fda.hhs.gov