Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that, at least 24 months after the issuance of a final guidance document in which the Agency has specified the electronic format for submitting certain submission types to the Food and Drug Administration (FDA or the Agency), the content of such submissions must be submitted electronically and in the format specified by FDA. This guidance and the technical specification documents it incorporates by reference (see Reference List) describe how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act.
Therefore, 24 months after this guidance document is finalized, where this guidance document specifies the electronic format for content submitted to the Agency, sponsors and applicants must submit the content to the Agency electronically in the format specified in this guidance document. Submissions that are not submitted electronically and electronic submissions that are not in the format specified in this guidance document will not be filed, unless exempted from the electronic submission requirement.
When finalized, this guidance will supersede the guidance for industry titled Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications that was issued in June 2008.