The Canadian Module 1 eCTD backbone file includes document information for each Module 1 document. This information is provided within an XML leaf element as defined by the ICH. Detailed information ...

From Health Canada. Current status: Closed. Opened on June 26, 2019 and will close to new input on August 26, 2019. This is a technical document that provides instruction on how to implement the ...

Refer to the Module 1 specification (see table above) for details on the Module 1 envelope. After completing this, browse to or copy-paste the path to the sequence directory (e.g. C:\eCTD\sample\0000) ...

Octagon’s eCTD Viewer, v.2.6.0; Octagon’s eCTD Validator, v.2.6.0; A key feature of the new releases includes support across all three products for eCTD EU Module 1 Specification, version 1.4. The new ...