eCTD Preparation for FDA Submissions: Technical Files & Guidelines

The FDA uses a particular type of document format when receiving food and drug regulatory information. The format is instantiated in their electronic common technical documents (eCTDs). Help with eCTD preparation is available on the FDA website.

eCTD

• FDA electronic common technical documents (eCTDs), or simply "technical files," are document formats used for submitting regulatory information to the FDA. Such formats are in place to make the submission of food and drug regulatory information easier to compile and analyze.

Preparation

• The FDA recommends a series of steps be taken in preparation for the submission of a technical file. Generally, the administration recommends viewing recent eCTD presentations by FDA staff and continually referring to the guiding documents for technical file submission that are available on the FDA website.

Guiding Documents

• Technical file guiding documents include the Published Guidance and Specifications document, the Comprehensive Table of Contents Headings and Hierarchy document, and the Study Data Specifications document.