FDA Relaxes eCTD Format to Give More Flexibility to Applicants

In a new guidance released this week FDA revised the CTD and eCTD formats of market approval applications for drugs and biologics (NDA, ANDA and BLA) with the intent to simplify the documents and provide higher flexibility for organizing content. FDA also withdrew two previous guidance documents that described detailed granularity instructions giving excruciating details of what should be included in the applications. Unlike the previous rigid structure, in the new guidance all sections of the CTD have been given three color codes: Yellow for main folders, purple for sections where all information should be located in one file, and green with sections where the applicant has flexibility to submit as many or as few files they want to include based on their judgment of what would be easier to understand by the reviewers. The guidance eliminates most table-of-content sections of the CTD for the eCTD format, and requires that electronic documents be formatted for ease of printing, if needed. This is likely due to several FDA reviewers still preferring to review off printed documents rather than read on the computer screen. The other differences are primarily in providing flexibility to the applicant in decisions regarding the need for splitting reports and files into smaller components versus providing all information in one file. The applicants can now decide to not split smaller reports and submit one file containing the full document. These changes appear intended to help more applicants transition from paper to electronic by making the electronic format closer to the paper format. However, companies that already were comfortable with the highly granular format, may keep using it. The guidance also answers many other questions about format of the documents that previously were scattered across multiple guidance documents, which should be welcomed by all applicants, big and small.