Electronic submission of IND safety reports to FDA

FDA is announced the availability of a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format:  IND Safety Reports.” 

This guidance describes the electronic format, sponsors will be required to use when they electronically submit to the FDA, IND safety reports for serious and unexpected suspected adverse reactions that are required under 21 CFR 312.32(c)(1)(i). FDA is establishing the electronic format requirements described in this guidance under section 745A(a) of the FD&C Act.

When the requirements of this guidance are in effect, this guidance will supersede the effective version of the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (eCTD guidance) as applicable to the electronic submission of IND safety reports required under 21 CFR 312.32(c)(1)(i) that are within the scope of this guidance.

This guidance

– will not replace any requirements in the eCTD guidance other than those relating to the electronic submission of IND safety reports required under 21 CFR 312.32(c)(1)(i) that are within the scope of this guidance.
– also references several technical specification documents that provide additional details about the format for electronic submission of IND safety reports to the FDA Adverse Event Reporting System (FAERS).

This guidance:
• implements the electronic submission requirements of section 745A(a) of the FD&C Act for the electronic format of the content submitted for IND safety reports that are required under 21 CFR 312.32(c)(1)(i) for serious and unexpected suspected adverse reactions.
• applies to IND safety reports that are submitted to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
• changes the electronic submission requirements for this category of IND safety reports by requiring sponsors to submit the IND safety reports to FAERS in accordance with this guidance. This requirement will be effective 24 months after the publication of the notice of availability of this guidance in the Federal Register (April 1, 2026). Until the requirements in this guidance become effective, the most recent effective version of the eCTD guidance will continue to apply to sponsors electronically submitting IND safety reports for serious and unexpected suspected adverse reactions. Before the effective date of the requirements outlined in this guidance, FDA will accept IND safety reports to FAERS as part of a voluntary submission program. During the voluntary submission program, if sponsors choose to submit IND safety reports to FAERS, they should no longer submit those IND safety reports in eCTD format. Please see the FAERS Electronic Submissions web page for more information on the voluntary submission process.

Reference – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-ind-safety-reports-guidance-industry