The Center for Drug Evaluation (CDE), under China's National Medical Products Administration (NMPA) , set new records in 2025 for both the number of drug registration applications it received and the number of reviews it completed, highlighting renewed vitality in the country's pharmaceutical research and development.
In 2025, CDE received a total of 20,149 drug registration applications, hitting a record high and recording a year-on-year increase of 3 percent, according to a report it released on Wednesday.
These applications include new drug clinical trial applications, marketing authorization applications for new drugs and generic drugs, and other supplementary applications.
Notably, among the registered drugs, applications for new drug marketing and new drug clinical trials saw significant growth.
"In 2025, the number of marketing authorization applications for new drugs increased by more than 20 percent year-on-year, and new drug clinical trial applications rose by over 13 percent. This shows that China's pharmaceutical industry is brimming with innovation, vitality and strong momentum. In the years ahead, we can expect more innovative drugs under development to move from research outcomes to clinical application," said Yuan Lijia, deputy director of the business management division of CDE.
In addition, the report reveals that in 2025, China completed the review of 19,375 drug registration applications, an increase of 6.11 percent year-on-year, also an all-time high.
"The volume of completed reviews for new drug applications in 2025 reached another record high, and more high-quality, novel drugs were approved for the market. This is strong evidence of the rapid development of China's biopharmaceutical industry. It not only brings more and better clinical treatment options to patients in China but also marks a solid foothold for the country in the global biopharmaceutical landscape, offering more 'Made in China' solutions to patients around the world," said Yang Zhimin, deputy director of the center.
China's drug applications, reviews hit record highs in 2025
