FDA Is Changing How IND Safety Reports Are Submitted — Here’s How to Prepare Before April 1, 2026

For many small and emerging pharma and biotech companies, IND safety reporting has followed a familiar path: expedited safety reports submitted to FDA as narrative PDFs in eCTD.

The Key FDA Guidances Driving This Change

This shift is driven primarily by two FDA documents that sponsors should review closely:

• 🔗 Providing Regulatory Submissions in Electronic Format: IND Safety Reports

• 🔗 Electronic Submission of IND Safety Reports – Technical Conformance Guide

Together, these guidances explain which IND safety reports must be submitted as ICSRs, how they must be structured, and where they must be submitted.

That’s about to change.

What’s Changing: From eCTD Safety Reports to IND ICSRs

Under the new framework, certain IND safety reports required under 21 CFR 312.32, must be submitted as IND ICSRs using ICH E2B(R3) Standards, rather than as narrative documents in eCTD.

These reports are submitted directly to FAERS, aligning investigational safety reporting more closely with postmarketing safety systems. Importantly, not all IND safety reports move to FAERS.

Reports based on:

• Overall findings from studies

• Animal or in vitro data

• Increased rates of serious suspected adverse reactions

will continue to be submitted in eCTD as narrative reports.

For sponsors, this creates a split reporting model that requires both safety-system readiness and continued regulatory operations expertise.

Why This Matters for Small and Start-Up Sponsors

For emerging companies, this is not just a technical update — it’s an operational shift.

Submitting IND ICSRs requires:

• Structured, validated safety data (not just narratives)

• Alignment with E2B(R3) standards

• FAERS-compatible submission pathways

• Clear coordination between safety, clinical, and regulatory teams

Without preparation, sponsors may face:

• Missed 7- or 15-day reporting timelines

• Rejected or incomplete submissions

• Confusion around where reports should be sent

• Costly, reactive system changes close to the deadline

6 Steps Companies Should Be Taking Now

1. Map Your Current IND Safety Reporting Workflow

Document how safety reports are handled today:

• How reportable events are identified

• How narratives are developed

• How and where reports are submitted

This baseline helps identify what will change — and what won’t — under the new requirements.

2. Clearly Distinguish Which Reports Become IND ICSRs

Not every safety report goes to FAERS.

Sponsors should ensure internal teams understand:

• Single-case reports and certain aggregate analyses → FAERS as IND ICSRs

• Overall findings and increased rate analyses → eCTD narrative submissions

This distinction is critical to staying compliant.

3. Assess Readiness to Support E2B(R3) ICSR Submissions

Even if your organization does not create ICSRs internally, you’ll need to ensure your safety partners or vendors can:

• Generate E2B(R3)-compliant ICSRs

• Manage follow-ups correctly

• Provide validated outputs suitable for FAERS submission

Now is the time to confirm those capabilities — not in 2026.

4. Plan for FAERS and ESG Submission Access

IND ICSRs must be submitted via:

• FDA’s Electronic Submissions Gateway (ESG), or

• The Safety Reporting Portal (SRP)

Sponsors should:

• Establish accounts early

• Confirm technical access

• Decide on single vs. batched submissions

Whether you’re submitting internally or having a vendor submit on your behalf, you’ll have to go through the testing process with FAERS to be approved to submit.

These steps often take longer than expected, especially for lean teams, so don’t leave this to the last minute. Starting the process early ensure plenty of time to untangle any snags and get prepped for the requirements to go live by April.

5. Update SOPs and Team Responsibilities

This transition affects more than one function. Sponsors should:

• Update SOPs to reflect the split reporting model

• Define clear handoffs between safety and regulatory operations

• Ensure staff are trained well ahead of the April 1, 2026 deadline

6. Consider Voluntary Early Adoption — Strategically

FDA is currently allowing voluntary submission of IND ICSRs to FAERS before the requirement becomes mandatory.

This may help some sponsors de-risk the transition, but FDA recommends that, once a sponsor begins submitting IND ICSRs to FAERS, they do not switch back to eCTD-based submissions.

This decision should be made thoughtfully, with input from both safety and regulatory teams.

How The Sugar Water Operations Team Can Help

The upcoming IND safety reporting changes highlight just how closely safety and regulatory operations must work together.

The Sugar Water Operations Team supports sponsors by:

• Submitting IND safety reports in eCTD where required

• Managing IND ICSR submissions to FAERS via the Electronic Submissions Gateway (ESG)

• Helping sponsors design practical, inspection-ready workflows for the new split reporting model

• Supporting INDs through submission, maintenance, and regulatory change management

While we do not create ICSRs, we work seamlessly with sponsors’ safety teams and vendors to ensure IND ICSRs are submitted correctly, on time, and in the right system.

If you’re unsure how these changes will impact your IND — or want help preparing well before April 1, 2026 — we’re happy to help you think it through. Contact Us — or connect with us on LinkedIn and sign up for our Newsletter to stay up to date.