Mar 08 2018

Deadline to Begin Submitting Commercial INDs in eCTD Format is May 5, 2018

By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist

Beginning on May 5, 2018, all commercial Investigational New Drug Applications (INDs) and master files must be submitted in the electronic common technical document (eCTD) format.

Section 745A(a) of the Food, Drug, and Cosmetic Act (FD&C Act) authorizes the United States Food and Drug Administration (FDA) to require that, no sooner than 24 months after issuance of a final guidance document in which the FDA has specified the electronic format for submitting submission types to FDA, such content must be submitted electronically and in the format specified by FDA. On May 5, 2015, FDA published a guidance titled Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 4 published in April 2017) that established timelines of 24 months for electronic submissions of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), certain Biologics License Applications (BLAs), and master files (May 5, 2017); and of 36 months for electronic submissions of commercial INDs (May, 5 2018).  After internal review and receiving comments from industry, FDA later determined that master files would instead follow the 36-month timeline as well (May 5, 2018).

The first deadline, applicable to marketing applications to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), arrived last year. Only marketing applications for drugs or combination products submitted under Section 505(b), (i), or (j) of the FD&C Act and marketing applications for biologics and combination products submitted under Section 351(a) or 351(k) of the Public Health Service Act were impacted.

However, the upcoming deadline of May 5, 2018, applicable to commercial INDs and master files, will affect companies at all stages of drug development. It is important to note, however, that the electronic submission requirements do not apply to submissions for blood and blood components and submissions for devices regulated by CBER, but electronic submissions of these types are still accepted.


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Common Questions
Common questions regarding electronic submission requirements and corresponding text from Revision 4 of Electronic Submission Requirements Guidance are presented below.

What types of submissions are exempt from electronic submission requirements?

“FDA has exempted all submissions regarding noncommercial INDs from the requirements under section 745A(a). For purposes of this guidance, the term noncommercial products refers to products that are not intended to be distributed commercially and includes investigator-sponsored INDs and expanded access INDs (e.g., emergency use INDs and treatment INDs).”

What format should be used for future submissions if the original application was submitted prior to the electronic requirement deadline?

“[Y]ou must electronically submit any amendments, supplements, and reports, even if the original submission was submitted to FDA prior to implementation of the electronic submission requirements.”

Why is FDA mandating that master files be submitted in electronic format, and what types of master files are affected?

“FDA considers master files to be submissions to an NDA, ANDA, BLA, or IND, and therefore to fall within the scope of requirements set forth in section 745A(a). These include new drug master files (DMFs) (21 CFR 314.420), new biological product files (BPFs) (21 CFR 601.51), and any amendments to or annual reports on previously submitted DMFs or BPFs.”

What is the penalty for noncompliance with electronic submission requirements?

“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.”