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Regulatory Focus™ > News Articles > FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years

FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years

Posted 07 May 2015 | By Alexander Gaffney, RAC

FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years

Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week.


FDA has received electronic submissions from drug companies since at least 2003, when it adopted the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD).

The submission standard is used by many of the world's top regulatory bodies, including the European Union's European Medicines Agency (EMA), Japan's Ministry of Health, Labour and Welfare (MHLW) and Health Canada.

At its core, the standard allows companies to submit an application for a new pharmaceutical or biological product to multiple regulators relatively easily. Prior to the widespread use of the eCTD, a drug sponsor would need to fill out each country's unique drug submission form—a tedious process which resulted in little or no benefit to either sponsors or regulators.

Since 2008, FDA has encouraged drug companies to submit applications—New Drug Applications (NDAs), Biologic License Applications (BLAs), Investigational New Drug Applications (INDs) and others—electronically using the eCTD. The electronic submissions are significantly easier for FDA to store and manage than paper-based submissions, which are often hundreds of thousands of pages long.

"The majority of new electronic submissions are now received in eCTD format," FDA says.

Coming Regulatory Compliance

To date, FDA has not required the submission of drug products using the eCTD. While a 2012 law known as the Food and Drug Administration Safety and Innovation Act (FDASIA) called for electronic submissions to eventually be made mandatory, it left the exact date of compliance up to FDA.

Section 1136 of FDASIA reads:

Beginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act shall be submitted in such electronic format as specified by the Secretary in such guidance.

The draft version of FDA's guidance document on eCTD submissions was released in January 2013. It explained that all products submitted under sections 505(b), 505(i), 505(j), 351(a) and 351(k) of the Federal Food, Drug and Cosmetic Act (FD&C Act) would need to be submitted electronically. In plain terms, that means that all new drugs, generic drugs, biologics, and biosimilar applications would need to be made electronically.

Clinical trial applications (INDs) would also need to be submitted electronically, but starting one year after the mandatory date of compliance for all other submission types.

Guidance Finalized

Now FDA has finalized its guidance document on eCTD submissions, setting into motion a countdown to the date of mandatory compliance.

The final guidance was published in the Federal Register on 5 May 2015, meaning most drug submissions will be required to be submitted electronically by 5 May 2017. Commercial INDs will need to be submitted electronically by 5 May 2018, FDA said. INDs for non-commercial products are not covered by FDA's guidance.

In a shift from the draft guidance document, FDA says it will also require new drug master files (DMFs), new biologic product files (BPFs) and any amendments to a DMF or BPF to be submitted electronically.

"A submission that is not in the electronic format(s) described in this guidance document will not be filed or received, unless it has been exempted from the electronic submission requirements with respect to that submission," FDA explained in the guidance.


Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications; Guidance for Industry (FR)


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