Sender-defined Keywords (SDKs) in submissionunit.xml

The eCTD 4.0 submissionunit.xml is a part of the eCTD submission package for health authority regulatory submissions.

The eCTD 4.0 submissionunit.xml contains submission unit information being submitted like application type, cross-referenced documents and submission metadata.

SDKs are included as submission metada in the eCTD 4.0 submissionunit.xml file. They allow the sender to provide the additional information about the submission for tracking, organization and searching.

The updateMode element indicates a name change in SDK .Ennov InSight records these changes providing a user with updated information. It is necessary for managing and tracking the updates for eCTD submissions.

The updateMode is supported for sender-defined keyword values, priority numbers and, leaf titles. When adding the SDKs to an updated sequence assembly, the new values appear in published output.

If a given SDKs value is same as the lifecycled published assembly within an application, the definition and the updateMode sections are not generated in the published output.

For published assemblies with newer sequences, SDKs is updated after the current assembly is published. The next publishing will have an updated value without the definition and the updateMode sections. In this case, the system uses the latest SDK value even if there is a difference between the current value and the last published value within the sequence. The last change of SDK is published within the application.