eCTD 4.0

eCTD 4.0 focuses on easing the process and review of regulated product information. eCTD 4.0 is the new standard in pharmaceutical industry that contains new requirements and improvements based on implementation and usage of eCTD v3.2.2.

The following are the eCTD 4.0 capabilities:

Single Submission Unit message

The Single Submission Unit message includes submissionunit.xml and submission content and contains information necessary for a sequence.

Context of Use

The Context of Use is used to add documents under a CTD heading and related keywords.

Keywords

Keywords define the submission information under an eCTD section. Keywords replace the eCTD 3.2.2 attributes and valid values.

A single keyword for each keyword type must be included in the context of use.

Context Groups and Life Cycle

A context group combines context of use and keywords and places a document under an eCTD section.

Document Reuse

The eCTD v4.0 message can include references to documents previously submitted in separate applications by referencing the unique identifier of a document.

Ennov InSight Publisher 7.3: eCTD 4.0

Ennov InSight Publisher eCTD 4.0