FDA Releases Guidance on Electronic Regulatory Submissions

FDA has released two guidance documents on providing regulatory submissions to the agency in electronic format. The first guidance, Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act, describes how FDA interprets and plans to implement the requirements of section 745A(a) of the Food, Drug, & Cosmetic Act (FD&C Act). The guidance details submission types that must be submitted electronically, exemptions from and criteria for waivers of the electronic submission requirements, and the timetable and process for implementing the requirements.

According to the guidance, FDA will periodically issue guidance documents that specify the electronic format for types of submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).  The goal of these guidance 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.

Because FDA believes that one guidance document will not be enough to address all the submissions covered by section 745(a) of the FD&C Act, individual guidance documents (e.g., Providing Regulatory Submissions in Electronic Format-Standardized Study Data and Providing Regulatory and Submissions in Electronic Format-Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications) will be developed to specify the formats for specific submissions and corresponding timetables for implementation.

The second guidance, Providing Regulatory Submissions in Electronic Format-Standardized Study Data, implements the electronic submission requirements of section 745A(a) of the FD&C Act for study data contained in NDAs, ANDAs, BLAs, and INDs to CDER or CBER by specifying the format for electronic submissions.

The guidance describes requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act. Study data contained in INDs, NDAs, ANDAs, and BLAs must be submitted electronically in a format that FDA can process, review, and archive. All subsequent submissions, amendments, supplements, and reports to these types of submissions must also be done electronically. The guidance 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.”