With the 26R1 release, to support organizations when reporting cases for products with multiple Marketing Authorization Holders (MAHs) to the Pharmaceuticals and Medical Device Agency (PMDA), Veeva Safety automates the population of Japan Case Product Registrations for each MAH based on Registration Holder/Applicant values on Product Registrations. For each MAH, Vault maps all investigational and one postmarketing Product Registration to domestic Cases and Localized Cases for Japan. This update supports generating distinct submissions based on the configured reporting rules for each MAH. Previously, Vault mapped Product Registrations for only a single MAH.
This feature is Auto-on; however, some components require additional configuration. After you have configured this feature, see Complete Intake and Process Cases for the PMDA and PMDA Case Field Reference for more information.
Update the Local Reporting Details Layout
Add the Registration Holder/Applicant field to the Details section of the Local Reporting Details Detail Page Layout of the Local Reporting Details object.