FDA Asks for Input on Post-Market Drug Safety Reporting
Published Date: 5/13/2026
Notice
Summary
The FDA wants your thoughts on how drug companies report problems after their products hit the market. This affects drug makers and healthcare folks who keep track of side effects. They’re asking for comments by July 13, 2026, to help improve the process without adding extra costs or paperwork.
Analyzed Economic Effects
6 provisions identified: 1 benefits, 5 costs, 0 mixed.
Mandatory ICH E2B(R3) Data Standard
If you submit postmarketing individual case safety reports (ICSRs) via FDA's Electronic Submissions Gateway Next Generation (ESG NextGen), those ICSRs must use the ICH E2B(R3) data standards beginning October 1, 2026. FDA began accepting E2B(R3) voluntarily in January 2024 and is now requiring the R3 standard on that date.
10- and 6-Year Recordkeeping Rules
Applicants and manufacturers must keep adverse drug experience records for 10 years under 21 CFR 314.80(j) and 310.305(g). For nonprescription human drug products under section 760(e), responsible persons must retain nonprescription adverse event records for 6 years.
Enhanced Pharmacovigilance Requests by FDA
FDA's January 2024 'Best Practices' may lead to enhanced pharmacovigilance activities for specific products; FDA may request use of targeted data collection tools, expedited submission of adverse experiences beyond minimum reporting, and summarization/assessment at FDA-defined frequencies. FDA has included burden estimates for these enhanced activities in its tables.
Periodic Report Timing Requirement
For approved drug applications, periodic postmarketing safety reports must be submitted quarterly for the first 3 years after U.S. approval and annually thereafter, per 21 CFR 314.80(c)(2) and 600.80(c)(2). These reports must include narratives, summaries, analyses, and indexes of adverse experiences.
5-Day Combination-Product Notification Rule
If a combination product event involves a drug and a constituent applicant receives information about a death, serious injury, or adverse event, that information must be provided to other constituent part applicants no later than 5 calendar days after receipt under 21 CFR 4.103. Rules for submission and recordkeeping for combination products are in 21 CFR 4.104 and 4.105.
Electronic Submission Waivers for Good Cause
All reports and followup reports generally must be submitted electronically, but FDA may grant temporary waivers of the electronic submission requirements for good cause. Waiver requests can be submitted under the cited regulations.
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