FDA sets October deadline for new safety reporting format

The US Food and Drug Administration (FDA) has announced that starting on 1 October 2026, manufacturers must submit adverse event individual case safety reports (ICSRs) for drugs, biologics, and combination products using the data standards specified in the International Council for Harmonisation’s (ICH) E2B(R3) guideline.

In a notice, FDA announced that it will no longer accept postmarketing ICSRs using ICH E2B(R2) data standards after 30 September 2026.

This update covers ICSRs submitted to FDA’s Adverse Event Monitoring System (AEMS) database, previously known as the FDA Adverse Event Reporting System (FAERS), that are submitted through the Electronic Submissions Gateway Next Generation (ESG NextGen) portal.

FDA said manufacturers should follow the ICH E2B(R3) implementation guidance issued in April 2022 for more information on the format.

The implementation guidance states that the ICSR “is made up of a large number of data elements, allowing precise reporting of medical content to most business partners, including regulatory authorities. For example, the data elements and their format are suitable to describe several types of case reports including those without adverse events or adverse drug reactions, such as medicinal product administration during pregnancy, overdose, medication error, or potential lack of efficacy.”

In the notice, the agency clarified the differences between the former ICH E2B(R2) standard and the ICH E2B(R3) standard. For example, there are new, modified, and expanded data elements; the assessment of seriousness is conducted at the event level instead of the case level; and attachments are embedded within the Individual Case Safety Report (ICSR) rather than provided separately.

FDA said it began accepting electronic submissions of post-marketing ICSRs in January 2024 on a voluntary basis. Submitters had the option to continue using the E2B(R2) standards for two more years.

This notice is the latest update on the mandatory adoption of the new format for reporting safety information.

FDA announced in March 2024 that starting on 1 April 2026, all investigational new drug applications (INDs) must be submitted using the E2B(R3) format instead of the electronic Common Technical Document (eCTD) format. (RELATED: FDA shifts IND safety reporting over to FAERS in finalized guidance, Regulatory Focus 29 March 2024)

Additionally, the agency in April 2024 finalized guidance stating that generic drug manufacturers must submit ICSRs in the new format for serious adverse events from bioavailability (BA) and bioequivalence (BE) studies that are exempt from IND requirements. (RELATED: FDA finalizes guidance on submission of BA/BE adverse event reports to FAERS, Regulatory Focus 1 April 2024)

In August 2024, FDA issued a regional implementation guidance for submitting ICSRs for drugs and biologics products. However, this only covered regional data elements that are not addressed in the ICH’s E2B(R3) implementation guideline.

FDA said in a notice that both the implementation guidance and the regional guidance were issued “to improve the quality of data in ICSR submissions and to enable improved handling and analyses of ICSRs.”

Notice