Technical Brief for Taiwan FDA E2B (R3)
(Doc ID 2682930.1)
Last updated on JANUARY 12, 2022
Applies to:
Oracle Argus Safety - Version 8.1 and laterOracle Argus Interchange - Version 8.1 and later
Oracle Argus Safety Japan - Version 8.1 and later
Information in this document applies to any platform.
Purpose
Taiwan FDA (TFDA) has published guidelines for testing E2B(R3).
Below are some guidelines to help customers to understand expectations of TFDA.
Scope
This article is applicable to Argus version AS 8.1+.
Details
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In this Document
| Purpose |
| Scope |
| Details |
| Taiwan FDA E2B (R3) |
| Creating a R3 Profile using the OOTB ICH E2B (R3) profile |
| Setting up a Reporting Destination for Taiwan FDA |
| Transmission of E2B (R3) file for Taiwan FDA |
| Entering local language data (optional) |