Learn how to configure your Vault to generate and submit individual case safety reports in the NMPA E2B(R3) format.
About the Feature
With the 25R1 release, Vault Safety supports generating and submitting NMPA E2B(R3) reports to Chinese localizations. This early adopter feature includes all regional data elements to ensure compliance with National Medical Products Administration (NMPA) requirements.
After configuring this feature, see E2B Generation: NMPA E2B(R3) Mapping and Standard Agency ICSR Submissions for more information.
Update the Localized Case Assessment Result Layout
Add the Localized Assessment Source field to all applicable Localized Case Assessment Result object layouts.
Update the Study Product Layout
Add the CTA Approval Numbers field to all applicable Study Product object layouts.