About eCTD Buddy

The site is maintained independently by professionals working in pharmaceutical regulatory submissions. It is not affiliated with, endorsed by, or acting for any regulator, industry association, or commercial organisation.

It is a static information index: no paid data services, no paid listings, and no commercial content of any kind.

It indexes official eCTD 3.2.2 and eCTD v4.0 documents, version status and implementation timelines by country and region. Every entry links directly to the regulator's own publication — we do not republish or rewrite official documents, only organise and annotate them.

Inclusion threshold: a new regional page is created only after at least one piece of official evidence exists — an eCTD specification, implementation guide or validation criteria published by the authority, an official timetable announcement, the ICH regional implementation table, or a format-conversion notice. Markets without official evidence appear only as rows in the global overview, never as standalone pages.

Upkeep rules: date precision is stated honestly (month-only when month is all that is known); mandatory dates are confirmed against the authority's own text; where this site and an official website disagree, the official source prevails and the discrepancy is noted alongside the entry; all entries are periodically re-verified, with the last-verified date shown on every page.

Content is provided for reference only and is not compliance advice; always verify against the regulator's latest official documents before making submission decisions.

For corrections, inclusion suggestions or anything else, please reach us via the Contact page or the email listed in the footer.