When working with South Korea (KR) regulatory submissions, Submissions Publishing allows you to generate KR eCTD v1.0 DTD compliant XMLs for submission to the Ministry of Food and Drug Safety (MFDS).

About Validation

Vault supports validation in accordance with the KR v1.0 Validation Criteria Version, with some exceptions detailed below.

As of the 23R3 release, the below validation criteria are not clearly defined by the Health Authority, and therefore are not supported. Upon updated guidance from the Health Authority, these Validation Criteria will be added:

  • M0020
  • M0022
  • M0023
  • M0024
  • M0025
  • M0026

About Node Extensions & Study Tagging Files

Though the KR eCTD specification does not explicitly state that Study Tagging Files (STFs) are supported, RIM Submissions Publishing supports both STFs and node extensions in the same submission.

If your submission contains both node extensions and STFs, they must exist in separate content plan sections. If your submission contains an STF XML, Vault creates STFs instead of node extensions.

Copying a Content Plan for KR Submissions

When copying a content plan from another submission, Vault removes all country-specific data with the exception of the STF Content Plan Item record to support other regions that accept STFs. In order for the publishing process to work correctly for copied submissions, you must set the Continuous Publishing and Continuous Validation fields to Yes on all Content Plan Items.

Viewing & Managing Submission Administrative Information

Vault supports viewing and managing Submission Administrative Information for KR 1.0 DTD. See Managing Submission Administrative Information for details.