In January 2017, the International Council for Harmonisation (ICH) updated the Step 4, Adoption of an ICH Harmonised Guideline, eCTD v4.0 Implementation Package for Modules 2 through 5. To be in alignment with the ICH updates, the FDA is providing an updated regional FDA eCTD v4.0 Module 1 Implementation Package for planning purposes only. Both the ICH and FDA Implementation Packages are technical instructions on how to implement the eCTD v4.0 specification.
NOTE: FDA will be requesting formal comments on the eCTD v4.0 Module 1 Implementation Package when the associated FDA eCTD v4.0 draft Technical Conformance Guide is posted for public comment through the Federal Register Notice process.
ICH eCTD v4.0 Step 4 – Implementation Package
- The ICH eCTD v4.0 Implementation Package and related files are available for download.
- To download the ICH Step 4 Implementation Package, please access the ICH eCTD v4.0 Step 4 page.
FDA eCTD v4.0 Regional/Module 1 – Implementation Package
To prepare for the FDA implementation of the eCTD v4.0 standard, FDA is making the following documentation available for download and should be used for implementation planning purposes only:
|USFDSA Module 1 Electronic Common Technical Document (eCTD) v4.0 Implementation Package History v1.1||Includes the release notes for each of the documents or files contained in the Implementation package.|
|USFDA Module 1 eCTD v4.0 Implementation Guide v1.1||Includes the instructions for the USFDA M1 submission contents. Note: This IG only contains contents not provided in the ICH IG. Refer to ICH IG for complete instructions.|
|USFDA Regional Controlled Vocabulary Spreadsheet||Includes region-specific vocabulary. Note – these files are intended as the human readable version of the controlled vocabulary content.|
|USFDA Regional Genericode Controlled Vocabulary Files||Includes region-specific vocabulary. Note – these files are intended for implementers to use as a computable version of the controlled vocabulary content.|
|USFDA Module 1 Regional XML Samples||Includes samples of common M1 content. Note – these samples do not include content in M2 – 5.|