FAERS reporting now goes to AEMS

Safety teams still say FAERS. The database FDA names on its electronic submissions page is the FDA Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). The Federal Register notice of 6 April 2026 uses that same former name. If your procedure, your gateway account, or your training still says only FAERS, put AEMS beside it.

This page is about the name, the ways a report can be sent, and what those FDA pages will and will not tell you. Signal review comes later. The regulatory lines below are tied to the sources at the end of the page.

What AEMS is and why the name changed

FDA says it is implementing AEMS to bring together reporting systems that today sit in different places. The AEMS electronic submissions page lists medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary medicines. The page says the platform is designed to standardize reporting, reduce administrative burden for FDA staff and for outside reporters, and strengthen safety surveillance. It also says AEMS will be a place for consumer complaints, regulatory misconduct reports, and whistleblower submissions across FDA centers.

Read the tense on that page. FDA is describing a system it is implementing, and a wider job the platform will do. The same page says it is there to help industry make certain electronic submissions to the AEMS database for the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. A drug or biologic ICSR is that narrower job. Confirm the live path before you assume a device, food, tobacco, or veterinary report now lands in the same file format.

The notice in 91 FR 17284 is narrower still. It announces an updated data standard for postmarketing individual case safety reports sent to the AEMS database, formerly FAERS. The products named are human drug products, biological products, and combination products led by a drug or a biologic. The path named is the Electronic Submissions Gateway Next Generation (ESG NextGen). The date named is 1 October 2026.

What stays the same for submitters

The 6 April 2026 notice does not announce a new reporting clock. It says FDA postmarketing safety reporting regulations already require persons who must report to submit ICSRs in an electronic format FDA can process, review, and archive. The notice points at those regulations, including 21 CFR 314.80(g)(1) and 21 CFR 600.80(h)(1). The duty to report still sits in the regulations. The notice sets the data standard for files that travel through ESG NextGen.

On the AEMS electronic submissions page, FDA says that beginning 1 October 2026, ICSRs submitted via ESG NextGen must use E2B(R3) data standards in the AEMS database. The page says FDA will continue to accept ICSRs prepared with E2B(R2) through 30 September 2026, for companies that have not yet switched. Once a company has begun submitting in E2B(R3), FDA expects all later ICSR submissions from that company to use E2B(R3). FDA also says the 6 April 2026 announcement extends the previously recommended E2B(R3) implementation period by six months. The page states the extension and the 1 October 2026 date. That sentence does not name the earlier recommended end date.

The practical rename is smaller than a new regulation. Keep saying FAERS where an old account, an old SOP, or a partner contract still uses it. Write AEMS next to it, with the words FDA uses: formerly FAERS. The E2B(R3) deadline guide is the page on this site for the October standard itself.

Submission routes

The AEMS electronic submissions page describes two electronic options for industry ICSRs.

• ESG NextGen. Database to database transmission of an XML file, using E2B standards. From 1 October 2026, postmarketing ICSRs on this path go to AEMS in E2B(R3). FDA posts the regional implementation guide and the core and regional data elements on the AEMS E2B(R3) data standards page.
• Safety Reporting Portal. Applicants, and responsible persons at companies that have reporting duties and do not have E2B capability, may submit premarketing ICSRs, postmarketing ICSRs, and attachments by entering them in a web form. FDA says to email the AEMS electronic submission contact to open an account, and that activation takes about 7 to 10 business days. A company that already submits through ESG NextGen cannot use the portal for those ICSRs and attachments. The AEMS page says that if you submit ICSRs through the portal, no action is required for the 1 October 2026 change. The Federal Register notice limits that data standard to ESG NextGen.

Voluntary reports from the public are a different door. MedWatch is FDA’s program for safety information and adverse event reports from health professionals, patients, and consumers. The page says MedWatch publishes safety alerts when that is appropriate. It also says tobacco, vaccines, and animal products use other portals, and that those reports should go there directly. A patient’s MedWatch report and an applicant’s ICSR to AEMS are different acts. Adverse event reporting on this site separates the event you keep from the report a sponsor sends.

One older form is still named for a narrow set of studies. For bioavailability and bioequivalence studies that are exempt from an IND, the AEMS page says electronic submission of the ICSRs is voluntary, and that you may continue to send those reports on Form FDA 3500A to the premarket safety reports mailbox listed there. That sentence is about those studies. It is not a general paper path for marketed product ICSRs.

What AEMS public data can and cannot tell you

The sources for this page are a submission instruction page, a two page Federal Register notice, and the MedWatch program page. They describe how reports are sent, and when MedWatch publishes an alert. They do not publish a count of reports in AEMS or in FAERS. This article does not add a count.

What those pages support is limited, and the limit matters:

• A file accepted into AEMS, formerly FAERS, is a report in the database FDA describes. The submission pages do not say that the report proves the product caused the event.
• A MedWatch safety alert is FDA deciding to publish. The MedWatch page does not say that every report becomes an alert.
• Nothing on these pages is an incidence rate. Asking AEMS, or the older FAERS name, how often an event happens in patients requires a different source than a gateway instruction.

Spontaneous reports are also incomplete. The notes on underreporting and on why reactions are never reported cite the studies they use. This page does not reuse those figures. A clean submission still cannot repair a report that never arrived.

Getting reports in clean

AEMS stores the submission it receives. On ESG NextGen that submission is an E2B file. On the Safety Reporting Portal it is what a person types into the form. The story has to exist, in fields, before either step.

At a small company the story usually arrives as email, a phone note, or a partner spreadsheet. Someone has to record who reported it, which patient it concerns, which product is suspected, and what happened, plus the date your company first had the information. PV case intake is that step. A reviewer accepts or overrides the draft. If you run Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety, or another safety database, that database remains the system of record for the file aimed at AEMS, formerly FAERS.

AE Connect is the intake workspace for that hour. The AEMS, FAERS, and MedWatch pages cited here do not name it, and they do not name any other vendor as a preferred way to report.