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Technical Brief for Taiwan FDA E2B (R3) (Doc ID 2682930.1)

Last updated on JULY 16, 2024

Applies to:

Oracle Life Sciences Argus Safety - Version 8.1 and later
Oracle Life Sciences Argus Interchange - Version 8.1 and later
Oracle Life Sciences 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 applies 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)
References

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