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U.S. Department of Health and Human Services

For Industry

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CBER ICSR Implementation

CBER is implementing the updated International Conference on Harmonisation’s (ICH) E2B(R3) Individual Case Safety Report (ICSR) specification to support electronic reporting of vaccine postmarketing safety reports as specified in the Electronic Safety Reporting Rule published June 10, 2014. Information about ICSR specifications supported by CBER is available at: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm174963.htm.
 

VAERS Electronic Reporting Resources:

  • FDA E2B(R3) Guidance to Industry:

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm275638.pdf
  • Electronic Vaccine Adverse Event Reporting System (eVAERS) Guidance:

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/
Vaccines/ucm405477.htm
  • FDA ICH E2B(R3) Regional Technical Specifications Document for Vaccine Reporting:

http://www.fda.gov/downloads/ForIndustry/ElectronicSubmissionsGateway/UCM395016.pdf
  • Appendix A to the FDA ICH E2B(R3) Technical Specifications Document is provided in PDF and XML format to demonstrate how FDA regional data elements are accommodated in the XML schema:

PDF Format: http://www.fda.gov/downloads/ForIndustry/ElectronicSubmissionsGateway/UCM406293.pdf
XML Format: http://www.fda.gov/downloads/ForIndustry/ElectronicSubmissionsGateway/UCM406308.xml

FDA Industry Meeting: Electronic Postmarket Safety Reporting Updates: