中國台灣
主管機關 衛生福利部食品藥物管理署（TFDA） 官方網站 ↗
eCTD v3.2.2 · TW M1
現行Taiwan's eCTD platform went live on 1 January 2022, opening voluntary eCTD filing for new drug and biologics applications; from 2 August 2023 post-approval changes may also be filed in eCTD without a full baseline (locking the licence to eCTD once opted in). Technical requirements are set by the Guidance for eCTD Filings: edition R1 (Dec 2020) became R2 on 28 April 2025 and R2.1 on 30 June 2025 (R2 repealed the same day; R2.1 effective 1 July 2026), with the Validation Guidance updated to V-R2.1 in step. The guidance follows ICH eCTD v3.2.2 for Modules 2–5 and defines a Taiwan-specific Module 1. The rollout has two steps: from 1 January 2026, eight new-drug registration categories must file online (eCTD or eSubmission; paper is withdrawn with refund); from 1 July 2027, NDAs for new chemical entities and biologics are accepted in eCTD only.
Watch both hard dates: after 1 Jan 2026 paper filings are withdrawn with fee refund (eSubmission still rescues them); after 1 Jul 2027 eSubmission stops working too — NCE and biologics applicants should structure dossiers to eCTD-R2.1 from their first filing cycle.
公告與動態
常見問題
When does Taiwan mandate eCTD?
In two steps. From 1 January 2026, registration applications for new chemical entities, biologics, new routes, new indications, new combinations, new dosage forms, new strengths and new unit contents must be filed online — eCTD or eSubmission — and paper filings are withdrawn with fee refund. From 1 July 2027, NDAs for new chemical entities and biologics are accepted in eCTD only; paper or eSubmission filings will be withdrawn and must be resubmitted in eCTD.
How are subsequent filings handled for licences with an eCTD Baseline?
Since 20 January 2026 the ExPRESS platform accepts "eCTD Baseline" filings: once a licence has established its eCTD Baseline, all subsequent variations and renewals must continue to be filed in eCTD. Earlier, since 2 August 2023, any licence may opt in to filing post-approval changes in eCTD without a full baseline — but once opted in, subsequent variations for that licence are locked to eCTD.
Which specification version is Taiwan eCTD based on?
The Guidance for eCTD Filings of Drug Registration (edition eCTD-R2.1, effective 1 July 2026) follows ICH eCTD Specification V3.2.2 for Modules 2–5 and defines a Taiwan-specific Module 1, with the technical package (tw-regional.dtd / tw-regional.xsl / tw-envelope.mod, etc.) published alongside. The companion Validation Guidance is edition eCTD-V-R2.1. There is no official v4.0 information yet.