The impact of China’s drug regulatory reform on access to orphan drugs: a cross-sectional study of diseases listed in the rare disease catalog
Yipeng Lan, Xiaofeng Lin, Zhe Huang, Wang Zan · 2026
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Description
Yipeng Lan and co-authors analyse access to rare disease drugs in China in a 2026 cross-sectional study. China listed 207 rare diseases across catalogues issued in 2018 and 2023. The study asks whether regulatory reform since then has improved drug supply for those conditions.
By late 2025, fewer than half of the listed diseases had any approved drug in China. For many diseases a single company supplied the only option. Review times shortened after the catalogue appeared, and the lag behind United States launches shrank. Insurance coverage also arrived faster, yet most listed diseases still lack treatment, which the authors say needs joint regulatory and insurance action.
Catalog record
| CREATOR | Yipeng Lan, Xiaofeng Lin, Zhe Huang, Wang Zan |
|---|---|
| YEAR | 2026 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 40 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |