USA – eCTD Technical Conformance Guide

This eCTD Technical Conformance Guide (Guide) provides specifications,
recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The Guide supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (eCTD Guidance).

The eCTD Guidance implements the electronic submission requirements of section
745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to
electronic submissions for certain investigational new drug applications (INDs); new
drug applications (NDAs); abbreviated new drug applications (ANDAs); certain
biologics license applications (BLAs); and master files submitted to CDER or CBER.
These submissions may apply to combination products with CDER or CBER as the lead
center…