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Product safetyFDAUnited StatesImports

Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 3.2.2 and Version 4.0

16 October 2026

In plain English

FDA's CDER and CBER set the date they will begin rejecting electronic submissions that fail new high-severity validation checks under eCTD Version 3.2.2 and Version 4.0.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
16 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing the date FDA will begin rejecting electronic submissions that fail new Electronic Common Technical Document (eCTD) Version 3.22 (v3.22) and Version 4.0 (v4.0) based validations. The new eCTD v3.2.2 validations are 2024 and 2025, which are high-severity validation errors as described in the Specifications for eCTD Validation Criteria. The ne
The full text is at the source

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