For Industry

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: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm174963.htm.
 

VAERS Electronic Reporting Resources:

  • FDA E2B(R3) Guidance to Industry:

  • Electronic Vaccine Adverse Event Reporting System (eVAERS) Guidance:

Sample ICSR E2B(R3) XML with only value responses:

 

Page Last Updated: 06/16/2016
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