Overview
Headline trends (human, CHMP-requested, 2014–2025 without 2018). ICSR / adverse reaction reporting (174 of 740 findings, 23.5%) and the quality management system (154, 20.8%) are the two largest areas; ICSRs ranked first in 7 of the 11 comparable years (2015–2017 and 2019–2022; tied with QMS in 2016). QMS ranks first in 2023 (27 findings), but in 2024 and 2025 it leads only once its training, written-instruction and SOP rows are merged (23 and 26); the reports themselves list adverse reactions first (22 in each year). Critical plus major made up 49% of findings in both 2014–2017 and 2019–2022, then 36% in 2023–2025; the drop coincides with the 2023 category revision, so it reads as a step change between periods rather than a continuing trend. No critical findings in 2019, 2021, 2022, 2024 or 2025 (critical peaks: 7 in 2015, 12 in 2020).
Inspections per year
Inspection profile
Joint inspections
Findings by grade over time
Findings by area
Harmonised categories over the selected years (original report labels under Methods). The per-inspection view leaves out years with no stated inspection count (2018 human).
Area × year heatmap
Focus on one area
Behind the top areas
What the reports say sits behind their leading finding area. Only the 2023–2025 reports give this, and only for one area per scope and year. Numbers are counts stated in the report; ● = sub-topic named without a count; † = the report says “mainly”. Sub-topic labels are ours; the source sentences are quoted under each table.