Eurasian Economic Union (EAEU)
Regulator Eurasian Economic Commission (EEC), Technical Regulation and Accreditation Department Official site ↗
EAEU Electronic Format
In forceThe EAEU requires its own electronic submission format (Board Decision No. 79, adopted 30 June 2017, in force 3 August 2017): the dossier follows the CTD structure (Modules 2–5 ICH-aligned, regional Module 1 per the Union's rules) plus the Union's own XML metadata — R.017 (application and product information) and R.022 (document list and lifecycle). Electronic submission has been mandatory for new marketing authorisation applications since 1 January 2021 and for follow-up submissions since 31 December 2025. This is not a regional implementation of ICH eCTD: v3.2.2 and v4.0 do not apply, and the EAEU is not listed in the ICH v4.0 regional implementation table.
Much submission software labels this format 'EAEU eCTD', but it is not a regional implementation of ICH eCTD — do not apply v3.2.2 / v4.0 tooling to EAEU submissions directly; follow the XML structure requirements of Board Decision No. 79.
Rules No. 78 (as amended)
In forceThe Rules for Registration and Examination of Medicines (Council Decision No. 78, adopted 3 November 2016, in force 6 May 2017) established the Union's unified registration procedure and the CTD dossier structure, with a variation framework aligned with the EU classification. Latest amendment: Council Decision No. 93 (adopted 26 November 2025, in force 26 December 2025) — introduces a 'confidential data' concept, revises variation classification and dossier-composition requirements, and clarifies expert evaluation procedures.
Notices & updates
FAQ
Does the EAEU use ICH eCTD?
No. The Union has its own electronic submission format (Board Decision No. 79, 2017): the dossier follows the CTD structure combined with the Union's own XML metadata (R.017 and R.022). It is not the same standard as ICH eCTD 3.2.2 / v4.0; what vendors call 'EAEU eCTD' refers to this own format.
When is electronic submission mandatory in the EAEU?
New marketing authorisation applications must be submitted electronically since 1 January 2021; follow-up submissions (variations, etc.) since 31 December 2025. Submissions go through the Union's integrated information system, with format requirements set by Board Decision No. 79.
What did Council Decision No. 93 (2025) change?
The decision (adopted 26 November 2025, in force 26 December 2025) amends the Rules for Registration and Examination: it introduces a 'confidential data' concept to protect applicants' commercial information, revises the variation classification, and clarifies dossier composition and evaluation procedures. Defer to the official text on the Union's legal portal.