FDA Draft Guidance on Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

In July 2014, FDA issued a revised draft guidance for industry titled “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The draft guidance closed for comments on September 23.

Twenty-four months after this guidance document is finalized, the content of certain submission types must be submitted electronically via the Electronic Submissions Gateway (ESG) and formatted according to the eCTD specifications outlined in this guidance.

These requirements apply to all submissions under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which include submissions under section 505(b) (new drug), 505(i) (clinical trial), or 505(j) (generic drug) of the FD&C Act, and under section 351(a) (biologic) or 351(k) (biosimilar) of the Public Health Service Act (PHS Act). These include:

• Certain INDs;
• NDAs;
• ANDAs; and
• Certain BLAs. 

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. FDA will exempt the following types of submissions:

• All submissions regarding devices that are regulated by CBER as biological products under section 351 of the PHS Act;
• Noncommercial INDs; and
• Existing master files previously submitted in non-electronic format.

This draft guidance is a revision of the draft guidance previously issued in January 2013. When finalized, it will supersede the guidance issued in June 2008 titled “Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.”

Contact RPI for assistance in meeting FDA’s new electronic submission requirements.