Beijing Fast-Tracks Novel Drugs as Medical Approvals Surge
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China’s regulatory approvals for new pharmaceuticals surged to a five-year high in 2025, as government efforts to fast-track novel treatments sparked a record number of green lights for first-in-class innovative drugs.
The National Medical Products Administration’s Center for Drug Evaluation said in its annual report released May 13 that it accepted 20,149 drug-registration applications last year, a 3% increase over the previous year. The agency completed reviews for 19,375 applications, representing an increase of 6.11%.
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- 2024：
- China approved 48 Class 1 innovative drugs; new drug applications were 549; pediatric drug approvals were 106.
- 2025：
- China approved 76 Class 1 innovative drugs (a 58.3% increase from 2024); new drug applications climbed 20.8% to 663; pediatric drug approvals reached 138, up from 106 in 2024; 48 medications for rare diseases were cleared; 80 'new drugs' previously marketed overseas were admitted; by end of 2025, China had eight CAR-T cell therapies; agency cleared 396 drug-shortage evaluations over the five years ending in 2025.
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