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CBER Vaccine 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: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-biologics/electronic-submission-postmarket-safety-reports.

VAERS Electronic Reporting Resources:

  • Appendix B: Consolidated Business Rules Document - Appendix B has been added to provide more information about eVAERS field lengths and datatypes for FDA regional data elements.
    XLS Format:
    https://www.fda.gov/media/98617/download

ATTENTION: FDA is making revisions to the eVAERS technical specification in order to accommodate the FDA Rule “Postmarketing Safety Reporting for Combination Products”, issued on December 20, 2016.    In addition, FDA has updated the corresponding eVAERS business rule document and sample XML file(s) which provide additional detail and specific requirements for each data field.

 

Proposed updates are provided here: https://www.fda.gov/vaccines-blood-biologics/vaccines/cber-vaccine-icsr-proposed-updates

 

Information about Postmarketing Safety Reporting for Combination Products, including the Rule, associated Draft Guidance for Industry and Staff, and Compliance Policy, is available at: https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products