Evidence / Definitions
Definitions used in the evidence
The definitions and reference figures the evidence uses, such as the world population and the rare disease threshold, each with its source.
3 figures, last read 6 Nov 2026. Each row opens the figure with its source and its own words.
Definitions (3)
EU definition of a rare disease: prevalence threshold for orphan medicinal product designationnot more than five in 10 thousand personsRegulation (EC) No 141/2000 on orphan medicinal products, Article 3(1)(a) · checkedWorld population8 billionUnited Nations, Global Issues: Population · checkedUS definition of a rare disease or condition under the Orphan Drug Actless than 200,000 persons in the United StatesFDA, Orphan Drug Act relevant excerpts (Section 526 of the FD&C Act) · checked