Republic of Korea

MFDS's eCTD v4.0 submission service has been running on nedrug.mfds.go.kr since 15 October 2026 (launch date per media reports of the MFDS announcement; the official page confirms the current state of parallel v3.2.2/v4.0 operation with v4.0 recommended for new filings). The service supports document reuse (citing previously submitted documents instead of re-uploading), one-to-many / many-to-one replacements and CTD catalog changes; it is accompanied by a v4.0 preparation handbook, user guides (authoring manual / technical specification), the ICH and regional controlled-vocabulary set and submission-file check rules, with a dedicated v4.0 FAQ category in the eCTD information centre. v3.2.2 and v4.0 run in parallel with a phased transition: existing approved items keep the current tool, while new item licence applications are 'recommended' to use v4.0 (권장, not mandatory); the mandatory date is not yet announced (TBD), consistent with the ICH regional implementation table (Aug 2026).

The mandatory date is not yet set, and neither is the end of parallel operation. New item licence applications can evaluate v4.0 under the official 'recommended' stance; dossiers already started in v3.2.2 remain valid and need no conversion. Regional differences concentrate in Module 1 and the Korea-controlled vocabulary (following the ICH vocabulary set); Modules 2–5 follow the ICH specification.

Korea's currently operating eCTD version. MFDS requires eCTD for drug-product licence (change) applications of CTD-scope products — new drugs, products subject to safety/efficacy review, herbal (oriental-medicine) preparations, biological products and advanced biologics; products outside that scope may also be submitted in eCTD voluntarily. MFDS provides the complete v3.2.2 submission tool (applicant authoring tool) with a companion authoring manual, DTD, submission-file check rules and submission guide. Existing approvals keep using the current (v3.2.2) tool; for new filings MFDS recommends moving to v4.0.

Mandatory current baseline for CTD-scope products (voluntary for others). Until v4.0 becomes fully mandatory, v3.2.2 sequences (including supplements and variations) stay valid — do not hold back ongoing-lifecycle sequences waiting for v4.0. New projects and new filings can prioritise evaluating the v4.0 path.