National Medical Products Administration: 2024 Annual Drug Review Report

In 2024, the number of drug registration applications continued to grow. The Drug Evaluation Center accepted 19,563 registration applications of various types (an increase of 5.73% year-on-year, calculated by acceptance number, the same below), including 17,476 drug preparation registration applications (an increase of 3.42% year-on-year) and 2,087 chemical raw material registration applications (an increase of 30.03% year-on-year). The 17,476 drug preparation registration applications included 15,318 technical review applications (an increase of 16.46% year-on-year) and 2,158 direct administrative approval applications (including supplementary applications and one-time imports).

Among the 15,318 technical review drug registration applications accepted in 2024, by drug type, there were 2,407 registration applications for traditional Chinese medicine, 10,464 registration applications for chemical drugs, and 2,447 registration applications for biological products.

According to statistics by registration application category, 3,073 applications for new drug clinical trials (this registration application category is hereinafter referred to as "IND"), 247 applications for confirmatory clinical trials, 549 applications for new drug marketing authorization (this registration application category is hereinafter referred to as "NDA"), 4,770 applications for marketing authorization for drugs with the same name and formula and chemical generic drugs (this registration application category is hereinafter referred to as "ANDA"), 659 registration applications for consistency evaluation of quality and efficacy of generic drugs (this registration application category is hereinafter referred to as "consistency evaluation application"), 5,600 supplementary applications, and 420 re-registration applications for drugs produced overseas.

In 2024, 2,407 applications for registration of traditional Chinese medicine were accepted. According to the categories of registration applications, there were 100 INDs, 40 NDAs, 2,262 supplementary applications, 2 ANDAs, and 3 re-registration applications for drugs produced overseas.

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