1 Introduction
MFDS, the South Korean Health Authority, published guidelines for Electronic Transmission of Individual Case Safety Reports E2B(R3) Data Elements and Message Specification [Specification for an Applicant] in January 2019. The final version of this guideline was approved on January 24, 2019.
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![Electronic Transmission of Individual Case Safety Reports E2B(R3) Data Elements and Message Specification [Specification for an Applicant]](img/image002.png "Electronic Transmission of Individual Case Safety Reports E2B(R3) Data Elements and Message Specification [Specification for an Applicant]")
Oracle Argus Safety is enhanced to support out-of-the-box E2B(R3) profile to submit PMSR and CT cases to South Korean Health Authority MFDS (Ministry of Food and Drug Safety). It is mandated that Pharma companies must submit ICSRs in E2B(R3) format starting January 1st, 2021.
There are 14 Regional elements added to those specified in the ICH E2B(R3):
| Element ID | Element Description (English) | Element Description (Korean) |
|---|---|---|
| C.2.r.4.KR.1 | Other Health Professional Type |  |
| C.3.1.KR.1 | Health Professional Type |  |
| C.5.4.KR.1 | Other Studies Type |  |
| D.8.r.1.KR.1a | Medicinal Product Version |  |
| D.8.r.1.KR.1b | Medicinal Product ID |  |
| D.10.8.r.1.KR.1a | Medicinal Product Version | |
| D.10.8.r.1.KR.1b | Medicinal Product ID | |
| G.k.2.1.KR.1a | Medicinal Product Version | |
| G.k.2.1.KR.1b | Medicinal Product ID | |
| G.k.2.3.r.1.KR.1a | Substance ID Version |  |
| G.k.2.3.r.1.KR.1b | Substance ID |  |
| G.k.9.i.2.r.2.KR.1 | MFDS Method of Assessment |  |
| G.k.9.i.2.r.3.KR.1 | WHO-UMC Result of Assessment |  |
| G.k.9.i.2.r.3.KR.2 | KRCT Result of Assessment |  |
This document lists best practices and recommendations for generating MFDS E2B(R3) report from Oracle Argus Safety.