US FDA
21 CFR 314.81(b)(2) - Annual Reports
Plain-language explanation, inspection context and common violation patterns.
What it says
Holders of an approved application must submit an annual report summarising significant new information from the previous year, including a summary of manufacturing changes reported during the year, distribution data, and a summary of labelling changes, providing FDA with a periodic, consolidated view of the product's status distinct from the immediate, event-driven Field Alert Report obligation.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- The annual report serves a fundamentally different regulatory purpose than the Field Alert Report covered elsewhere in this library, providing a periodic, retrospective summary rather than urgent, event-triggered notification, and both obligations can apply to the same underlying events viewed through different reporting lenses.
- Manufacturing changes reported during the year, even those handled through the lower-tier changes being effected or annual reportable categories under 314.70, must still be consolidated and summarised in this annual filing, connecting the two regulations directly.
- This report provides FDA with a periodic checkpoint on a product's ongoing status without requiring a new application-level review for every minor change, supporting a proportionate oversight approach for lower-risk post-approval changes.
What FDA inspectors look for
- Whether annual reports are filed completely and on schedule, accurately summarising the manufacturing and labelling changes that actually occurred during the reporting period.
- Whether changes reported through lower-tier 314.70 categories during the year are correctly consolidated and reflected in the subsequent annual report.
- This is primarily a periodic regulatory reporting obligation rather than a specific manufacturing practice inspected directly, though its accuracy depends on the underlying change control and documentation systems functioning correctly throughout the year.
Most common violation
Manufacturing changes correctly implemented and internally documented during the year but not accurately or completely captured in the subsequent annual report summary, creating a gap between actual practice and what was reported to FDA.
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