The Silver Tsunami Prescription: A Comprehensive Analysis of Approval Delays and Innovation Assessment in China's Novel Geriatric Drugs (2005–2024)

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Post-reform, the median relative approval lag for geriatric drugs decreased from 53.9 to 29.9 months, but still lagged behind EU and Japan.
Despite a surge in domestic innovative drug approvals, the focus remained on oncology, leaving other high-burden conditions under-addressed.
Expedited approval programs shortened development duration, but China's review times still lagged behind the FDA averages by several months.
Future regulatory efforts should incorporate real-world evidence and optimize trial designs to better meet the unique needs of older adults.

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Cross-sectional analysis reveals reduced approval lag for geriatric drugs in China, highlighting regulatory challenges.

Xu et al. (2025) studied this question.

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