In May 2026, the Drug Evaluation Center of the National Medical Products Administration (CDE) officially released the "2025 Annual Drug Evaluation Report".

In 2025, the number of drug registration application submissions continued to increase. The Drug Evaluation Center received 20,149 various registration applications (a year-on-year increase of 3.00%, based on the application number, the same below), including 18,448 registration applications for drug formulations (a year-on-year increase of 5.56%), and 1,701 registration applications for chemical raw materials. Among the 18,448 drug formulation registration applications, there were 16,130 technical review-based registration applications (a year-on-year increase of 5.30%) and 2,318 direct administrative approval-based registration applications (including supplementary applications and one-time imports). 

In 2025, 16,130 technical review-based drug registration applications were processed. According to the type of drugs, there were 2,723 applications for traditional Chinese medicine, 10,587 applications for chemical drugs, and 2,820 applications for biological products.

According to the statistics by registration application category, 3,756 clinical trial applications were accepted, 663 new drug marketing authorization applications (the above-mentioned registration application category is hereinafter referred to as "NDA") were submitted, 4,591 applications for marketing authorization of identical-name and identical-form drugs and chemical generic drugs (the above-mentioned registration application category is hereinafter referred to as "ANDA") were filed, 430 registration applications for consistency evaluation of generic drugs (the above-mentioned registration application category is hereinafter referred to as "consistency evaluation applications") were submitted, 6,293 supplementary applications were received, and 397 re-registration applications for imported drugs were submitted.

In 2025, 2,820 registration applications for biological products were accepted, including 191 registration applications for preventive biological products, 2,620 registration applications for therapeutic biological products, and 9 registration applications for in vitro diagnostic reagents. 

According to the classification of registration applications, there were 1,429 clinical trial applications, 299 NDA applications, 1,037 supplementary applications, and 55 re-registration applications for imported pharmaceuticals.

According to the registration classification statistics, there were 102 applications for clinical trials of preventive biological products, including 61 applications for clinical trials of innovative vaccines (covering 43 varieties), 15 applications for clinical trials of modified vaccines (covering 11 varieties), and 26 applications for clinical trials of domestic or foreign marketed vaccines (covering 16 varieties); 21 applications for NDA of preventive biological products included 4 innovative vaccine NDA (3 varieties), 3 modified vaccine NDA (2 varieties), and 14 domestic or foreign marketed vaccine NDA (10 varieties).

According to the registration classification statistics, there were 1,327 clinical trial applications for therapeutic biological products. Among them, 1,073 were applications for innovative therapeutic biological products (covering 674 varieties), 192 were applications for modified therapeutic biological products (covering 85 varieties), and 62 were applications for therapeutic biological products that were already on the market domestically or abroad (covering 47 varieties). 

272 applications for new drug approvals for therapeutic biological products include 50 innovative therapeutic biological product applications (covering 35 varieties), 89 modified therapeutic biological product applications (covering 36 varieties), and 133 domestic or foreign marketed therapeutic biological product applications (covering 60 varieties).

In 2025, 2,318 direct administrative approval registration applications were processed, including 1,927 supplementary applications that did not require technical review and 391 temporary import registration applications.

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