This Friday (13 Septmeber, 2024) the USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released final guidance "Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry" that describes how sponsors and applicants can organize the content they submit electronically to the Agency under section 745A(a) of the FD&C Act for all submission types.
This guidance also references several technical specification documents and the electronic common technical document (eCTD) Technical Conformance Guide, which provide additional details regarding the organization of content for electronic submissions.
Submissions for INDs, NDAs, ANDAs, Biologics License Applications (BLAs), and certain amendments must follow eCTD format. This is essential for initial applications, reports, supplements, and other submission types, making the review process faster and reducing administrative burdens.
The guidance sets specific timelines for mandatory electronic submissions. It is crucial for sponsors to comply with these timelines to avoid delays in their application reviews. Non-compliance with eCTD submission requirements can result in a "refuse to file" action by the FDA.
Certain submission types, such as Drug Master Files (DMFs) other than Type II DMFs, may be exempt from the eCTD requirement. These exemptions are described to ensure applicants understand the scenarios in which paper or alternative formats might still be acceptable.
Submissions related to positron emission tomography (PET) drugs and Type II DMFs may qualify for waivers from eCTD requirements. Sponsors of these types of submissions should follow the outlined process to request waivers.
1. PET Drug Submissions: PET drugs, due to their unique characteristics, may have different submission requirements.
2. Type II DMF Submissions: Certain submissions classified as Type II DMFs may be eligible for eCTD waivers.
Waiver requests should be sent to the FDA, and the response times for these requests are clearly defined. In certain cases, short-term waivers may be granted for submissions that would otherwise need to be in eCTD format. The guidance provides specific instructions on how to apply for these waivers, including the content of the requests and the submission channels.
The guidance refers to various technical specification documents that applicants must adhere to when preparing their submissions. These specifications cover file formats, folder structures, granularity of submission content, and the overall submission life cycle.
For more information, refer to:
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