Module 12 2019

ICH eCTD 4.0 FDA – Status

• Implementation Guide v1.1, February 2017

• Document reuse: reusing & referencing documents across submissions/electronic dossiers/different products/agencies

• Harmonized submission unit

• Context of Use life cycle: meta data lifecycle, “append” operation removed

• Function of document groups: replacing the STFs

• 2-way communication Applicant ↔ Agency: will be implemented from the beginning in FDA, a posteriori in EU

• Controlled vocabularies

The Organisation for Professionals in Regulatory Affairs