South Korea MFDS updates

The MFDS E2B(R3) profile has been updated to incorporate the following:

• Updated business rules as of 14-May-2020 and 11-Jun-2020.
• Updated XML file reference as of 7-May-2020 and 20-Jul-2020.

Mappings of the following elements have been updated:

• DRUGADMINISTRATIONROUTETEXT [G.k.4.r.10.1 ] and DRUGPARADMINISTRATIONTEXT [G.k.4.r.11.1]
• DRUGROUTEOFADMINTERMIDVER and DRUGROUTEOFADMINTERMID [G.k.4.r.10.2a/ G.k.4.r.10.2b ]
• DRUGPARROUTEOFADMINTERMIDVER and DRUGPARROUTEOFADMINTERMID [G.k.4.r.11.2a/ G.k.4.r.11.2b ]
• Format change of output in PATIENTMEDICALPRODUCTVERSION [D.8.r.1.KR.1a], PARENTMEDICALPRODUCTVERSION [D.10.8.r.1.KR.1a], DRUGMEDICALPRODUCTVERSION [G.k.2.1.KR.1a], SUBSTANCEVERSION [G.k.2.3.r.1.KR.1a]
• PATIENTBIRTHDATER3 [D.2.1]
• PATIENTONSETAGE [D.2.2a] and PATIENTONSETAGEUNITR3 [D.2.2b]
• GESTATIONPERIOD [D.2.2.1a] and GESTATIONPERIODUNITR3 [D.2.2.1b]
• PATIENTAGEGROUP [D.2.3]
• REACTIONOCCURCOUNTRY [E.i.9]
• STUDYNAME [C.5.2]
• STUDYREGNUMB [C.5.1.r.1]

Validations of the following element has been updated:

• OTHERSTUDIESTYPE [C.5.4.KR.1]
• DRUGMEDICALPRODUCTID [G.k.2.1.KR.1b]
• REACTIONOCCURCOUNTRY [E.i.9]
• PATIENTINVESTIGATIONNUMB [D.1.1.4]
• PATIENTSEXR3 [D.5]

The XML reference file provided by the South Korea MFDS for Individual Case Safety Reports (ICSRs) has been incorporated.

Console changes

To transmit the STUDYNAME [C.5.2] element in the Korean language for E2B(R3) submissions to MFDS, Console > Study Configuration > Study Description has been enhanced to support multi-language data entry. The list of languages is the same as the standard set of languages supported in the case form fields, like Narratives. Data configured in French, German, Italian, or Spanish has been retained as-is in the multi-language data entry window.

For more information, refer to the ArgusInterchange823_E2B (R3) Export Mappings.xlsx.