Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        FDA Data Standards Advisory Board

Individual Case Safety Reports Home
          For Industry
          FDA Data Standards Advisory Board
          Individual Case Safety ReportsFDA Data Standards Advisory Board Individual Case Safety Reports
  	
        Share
    Post
    Linkedin

    Email
    PrintDescription:  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 EventsFood Adverse EventsHuman Drugs Adverse EventsMedical Device Adverse EventsVeterinary Adverse Events**Tobacco Adverse Events**ICSR Guidance Documents, Implementation Guides, Specifications, Schema Files, and Validation ProceduresSchema Files and Validation Procedures Schema FilesHuman Drugs, Biologics and VaccinesDraft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including VaccinesE2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards CompatibilityGuidance for Industry Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed without an Approved ApplicationGuidance for Industry: Providing Regulatory Submissions in Electronic Format — Postmarketing Individual Case Safety ReportsGuidance for Industry: Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and AnswersVaccine Adverse Event Reporting System (VAERS) Electronic SubmissionsMedical DevicesQuestions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA StaffVeterinary Products             Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary MedicineFood 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 DocketsFDA-2008-N-0334 Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission RequirementsFDA-2001-D-0067 Providing Regulatory Submissions in Electronic FormatFDA-1992-S-0039 Public Docket to Provide Information on Submissions the Agency is Prepared to Accept ElectronicallyContact InformationQuestions regarding ICSR submissions should be directed to:Human Drugs: faersesub@fda.hhs.govBiologics and Vaccines: CBERICSRSubmissions@fda.hhs.govVeterinary Products: CVMAESupport@fda.hhs.govMedical Devices: emdr@fda.hhs.gov

                                                                                  Content current as of:
      03/27/2018
                  
                   
Regulated Product(s)
		 Animal & Veterinary
			  			     			  			     Biologics
			     			  			     Drugs
			     			  			     Medical Devices
			     			  			     Dietary Supplements
			     			  						              
			
			
			
						   Medical Food/BeverageIndividual Case Safety Reports
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop