Postmarketing Reporting of Adverse Experiences (Biological Products)
The US regulation requiring holders of a biologics license to report postmarketing adverse experiences to FDA — serious and unexpected cases as expedited 15-day Alert reports, plus periodic reports — the biologics twin of 21 CFR 314.80 for drugs. Licensees must review adverse-experience information from any source, foreign or domestic, including scientific literature and postmarketing studies, and submit electronically to FAERS.
What this does not cover
stated in the document's own scope- Applies to licensed biological products under a BLA; adverse-experience reporting for drugs approved under NDAs and ANDAs is 21 CFR 314.80.
- Covers postmarketing reporting; safety reporting during clinical investigations is governed by the IND regulations in 21 CFR 312.32.
- Addresses adverse-experience reporting; the CGMP requirements for blood and blood components, including their own reporting duties for fatalities, sit in 21 CFR Part 606.
- Vaccine adverse events also flow through specific programmes such as VAERS under separate statutory authority; 600.80 remains the license holder's reporting rule.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR 600.80 is the FDA regulation for postmarketing adverse-experience reporting on licensed biological products — the biologics counterpart of 21 CFR 314.80 for drugs. A biologics license holder must promptly review adverse-experience information about its product from any source, foreign or domestic: commercial marketing experience, postmarketing clinical investigations, postmarketing epidemiological or surveillance studies, reports in the scientific literature, and unpublished scientific papers. Each adverse experience that is both serious and unexpected must reach FDA as a 15-day Alert report, no later than 15 calendar days from initial receipt, with follow-up investigation reported on the same clock; all other adverse experiences flow into periodic reports. Submissions are made electronically and populate the FDA Adverse Event Reporting System (FAERS).
Scope & applicability
Holders of an approved biologics license application (BLA) for marketed biological products, including vaccines and blood derivatives. The parallel rule for drugs approved under NDAs/ANDAs is 21 CFR 314.80.
Legal basis & how it acquires force
A regulation in Subpart D of 21 CFR Part 600 (Biological Products: General), issued under the Public Health Service Act's biologics-licensing authority (42 U.S.C. 262) and the Federal Food, Drug, and Cosmetic Act. Compliance is an obligation of holding a biologics license. The 2014 final rule on postmarketing safety reports for human drug and biological products amended it to require electronic submission.
Document structure
| Part | Covers |
|---|---|
| Definitions | The postmarketing meanings of adverse experience, serious, unexpected, and related terms for biologics |
| Review of adverse experiences | The obligation to promptly review safety information from any source, foreign or domestic |
| Reporting requirements | 15-day Alert reports for serious, unexpected adverse experiences, follow-up investigation, and periodic reporting for all other cases |
| Scientific literature and postmarketing studies | When published reports and study-derived adverse experiences trigger 15-day reporting |
| Electronic submission and records | The required electronic format for reports and the recordkeeping supporting them |
Key requirements
- Promptly review adverse-experience information from any source, foreign or domestic
- Submit adverse experiences that are both serious and unexpected as 15-day Alert reports
- Submit periodic adverse-experience reports on the required schedule
- Investigate and submit follow-up information for 15-day reports
- Submit reports in electronic format
Implementation tips
- Run biologics and drug safety reporting on one process where possible — 600.80 and 314.80 are structured as twins, so a single global SOP with product-type branching avoids divergence
Revision notes
Amended by the 2014 final rule on electronic submission of postmarketing safety reports, which made electronic format mandatory.
International alignment
600.80 mirrors 21 CFR 314.80, so a marketing authorisation holder with both drugs and biologics runs one surveillance process with two regulatory homes. Internationally it is the US regulatory implementation of the ICH post-approval safety framework: definitions and case-management practice from ICH E2D(R1), electronic transmission via the E2B(R3) ICSR standard into FAERS. Its EU counterpart is the pharmacovigilance regime of Regulation (EC) No 726/2004, Directive 2001/83/EC, and Implementing Regulation (EU) No 520/2012.
21 CFR 600.80: frequently asked questions
Quick answers to common questions about 21 CFR 600.80.
What must be reported under 21 CFR 600.80 within 15 days?
Each adverse experience that is both serious and unexpected, whether foreign or domestic, must be submitted as a 15-day Alert report no later than 15 calendar days from the license holder's initial receipt of the information, followed by prompt investigation and follow-up reporting on the same clock.
How does 600.80 relate to 21 CFR 314.80?
They are structural twins: 314.80 governs postmarketing adverse-experience reporting for drugs under NDAs/ANDAs, 600.80 for biological products under BLAs. The definitions, the 15-day expedited pathway, and the periodic-reporting scheme run in parallel, which is why many firms operate a single global process across both.
Must 600.80 reports be submitted electronically?
Yes. The 2014 final rule on postmarketing safety reports made electronic submission mandatory, and reports feed the FDA Adverse Event Reporting System (FAERS).
Does 600.80 cover adverse events in clinical trials of a licensed biologic?
Postmarketing clinical investigations are among the sources a license holder must review, and serious, unexpected adverse experiences from them are reportable. Trials conducted under an IND, however, follow the IND safety-reporting rule at 21 CFR 312.32 for that investigational use.