Trends, lag and characteristics of rare disease drug approval in the USA and China, 1983-2022.

Orphanet J Rare Dis · 2025 · PMC12750715 · PMID 41430297

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a clear trendno p-value reported

Conclusions By analyzing the approval lag for rare disease drugs between the USA and China, this study reveals a clear trend: from 1983 to 2022, a growing number of these drugs have been approved in both countries, with the approval lag in China consistently decreasing.

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