Module 1 2021

25/06/2021

• The eCTD is a specification for an electronic submission created by the ICH • The concept of a common global electronic submission format was an early topic for the ICH ─ Unfortunately, there was no global submission format, so the electronic submission topic had to wait for the CTD to be developed • The intention is to give a common format for the electronic version of the CTD dossier ─ This means it has to accommodate all of the “features” of the CTD • The common dossier structure provided by the CTD AND • The regional content requirements ─ ICH have defined the “common” part, but each region/country must also define their pieces as well The eCTD

The Organisation for Professionals in Regulatory Affairs

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eCTD Lifecycle Management

• One of the key features of the eCTD is “Lifecycle Management” • This is providing information about the relationship of one document to another ─ Represented by the “operation” attribute • “new”, “replace”, “delete” and “append” ─ And the “modified file” attribute • And also providing information about the relationship of one submission to another ─ Represented by “related sequence” attribute in the envelope

The Organisation for Professionals in Regulatory Affairs

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