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Changes in E2B Bilingual Codelist v2.9 - Steps to Perform in Argus Safety (Doc ID 2432367.1)

Last updated on AUGUST 07, 2018

Applies to:

Oracle Argus Safety - Version 8.1.1 and later
Oracle Argus Safety Japan - Version 8.1.1 and later
Information in this document applies to any platform.

Goal

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a new version of the E2B Bilingual Code Lists v2.9 as part of the E2B (R3) IG Complete Package v1_06 in November 2017.  The Pharmaceuticals and Medical Devices Agency (PMDA) R3 has published the same E2B Bilingual Code Lists v2.9 as revised guidance on 2-July-2018.

Below are the changes identified in E2B Bilingual Code Lists v2.9:

In the Patient age group codelist, below are the changes identified (file updated - E2B CL9 ich - patient-age-group.gc.xml):

  1. Correct the Japanese description for "2:infant" to "NYUYOJI" 乳幼児
  2. Correct the Japanese description for "3:Child" to "SHONI" 小児
  3. Version has been changed 2.0 > 2.1

In the Route of administration codelist, below are the changes identified (file updated - E2B CL14 ich - r2-route-of-administration.gc.xml):

  1. "046:Occlusive dressing technique" > deactivated (current flag: y > n)
  2. "057:Sunconjunctival" > English description has been changed to "Subconjunctival"
  3. Version has been changed 2.1 > 2.2

For PMDA, the transition period during which both v2.8 and v2.9 of the code lists will be accepted is from Jul 2nd, 2018 to Sep 28th, 2018.  Note that only the new version (v2.9) will be accepted once the transition period has ended.  Hence all customers are recommended to update their Argus Safety system for the updates in E2B Bilingual Code Lists v2.9.

This document provides a solution to apply the changes in the E2B Bilingual Code Lists v2.9 in Argus until it is provided as a part of the standard Argus product offering; this is logged as enhancement request Enh 28291094 - PMDA R3/ICH R3/EMA R3/eVAERS guidance updates – Codelists

Solution

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