Brazil

Regulator　ANVISA (Brazilian Health Regulatory Agency)　Official site ↗

Content updated 2026-10-06Source verified 2026-10-06No official datespecs 1links 1

eCTD v4.0

Draft / transition

The ICH regional implementation table lists ANVISA's migration timeline: a technical pilot planned for Q4 2026, voluntary acceptance from 2027, and a mandatory date still to be determined. ANVISA has not yet published a regional eCTD v4.0 implementation guide.

Technical pilot2026 Q4

Voluntary2027

MandatoryTBD

Pilot and mandatory dates may still change before ANVISA's own announcements; verify against ANVISA's official publications — this page follows the ICH table.

Official documents

ICH eCTD v4.0 regional implementation information (incl. ANVISA row) ich.org

Notices & updates

No notices recorded for this region yet.

FAQ

When does Brazil start the eCTD v4.0 technical pilot?

According to the ICH regional implementation table, ANVISA's technical pilot is planned for Q4 2026. This is the ICH-table baseline and may still change before ANVISA's own announcement.

When will eCTD v4.0 become mandatory in Brazil?

There is no official mandatory date yet: the ICH table lists ANVISA's mandatory date as TBD. Defer to ANVISA's official announcements.

What is the source of the information on this page?

The timeline on this page comes from the ICH eCTD v4.0 regional implementation table (updated August 2026); refer to ANVISA's website and the ICH page for official documents and follow-up announcements.