The introduction and acceptance of electronic submissions as the preferred submission process has been adopted at varying rates by different jurisdictions within the three ICH regions over the past several years. This move to provide a harmonized format has benefited companies as it is now easier to adapt a submission prepared for one jurisdiction to the requirements of another. The FDA has accepted drug submissions in eCTD format since 2003, and began recommending eCTD format in 2008.
This past December, 2014, the FDA released two final guidance documents providing direction on electronic regulatory submissions and their acceptable format. It is important to highlight that these two guidances do not prescribe to the standard language which identifies them as a recommendations for industry – these guidances have been provided specific authorization by Congress to present and contain only binding provisions that must be followed for a successful submission (unless provided an exemption).
The guidance entitled, Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act, provides information on the types of submissions that must be submitted using electronic format, as well as “exemptions from and criteria for waivers of the electronic submission requirements, and…the timetable and process for implementing the requirements.” As such, the guidance aims to provide insight on how the “FDA interprets and plans to implement the requirements of section 745A(a) of the Food, Drug, & Cosmetic Act (FD&C Act).”
The FDA also states in this guidance document that it will periodically issue guidance documents on electronic format for submission types such as new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs).
The second guidance, Providing Regulatory Submissions in Electronic Format—Standardized Study Data, was issued by the FDA to help companies implement the requirements for submitting standardized clinical and nonclinical study data using electronic format provided under section 745A(a) of the FD&C Act. The purpose of releasing this guidance is so that the study data included in submissions such as INDs, NDAs, ANDAs, and BLAs are in a format that FDA can process, review and archive. According to this guidance document, FDA requires that all the subsequent submissions, including amendments, supplements and reports to: INDs, NDAs, ANDAs, and BLAs be submitted electronically. This second guidance also states that, “submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless exempted from the electronic submission requirements.” Importantly this guidance applies to the submission of data for both clinical and nonclinical studies.
The main purpose of these two documents is to “harmonize and streamline the process for implementing the various required formats for electronic submissions under section 745A(a) of the FD&C Act.” The documents should be viewed in their entirety, and can be found here:
Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act:
Providing Regulatory Submissions in Electronic Format – Standardized Study Data: