The Center for Drug Evaluation (CDE) has released its annual drug review report for 2023, highlighting a continued increase in drug regulatory filings. The CDE accepted 18,503 filings of various types, marking a 35.84% year-on-year increase. Within this figure, 3,745 filings required no technical review for direct administrative approval, an increase of 22.11% year-on-year. A total of 13,144 cases necessitated technical review, including 9,813 chemical drug filings (up 39.11%), 2,168 biological product filings (up 19.12%), and 1,163 traditional Chinese medicine filings (up 176.25%).
In terms of categories, 2,997 Investigational New Drug (IND) filings were accepted, an increase of 33.56%, along with 470 New Drug Applications (NDAs), up 40.72%. There were 3,852 filings for same name and same formula drugs and chemical generic drugs, up 66.25%, 1,006 filings for GQCE – generic drug quality efficacy consistency evaluation, up 20.48%, 4,115 supplementary applications, up 36.26%, and 534 re-registration applications for overseas manufactured drugs, up 28.06%.
Throughout the year, 40 varieties of Class 1 innovative drugs received marketing approval. This includes 9 that were approved through the priority review route, 13 that were conditionally approved, and 4 COVID-19 therapeutic drugs approved with special procedures. A total of 45 varieties of rare disease drugs were approved (excluding Category 4 chemical drugs for rare diseases), with 15 receiving priority review status and 21 conditionally approved. Additionally, 92 varieties of children’s medication products were approved, and 20 varieties had their indications expanded to include children. The year also saw the approval of three CAR-T cell therapies, including the conditional first approvals for Fukesu (equecabtagene autoleucel) and Yuanruida (inaticabtagene autoleucel), as well as a new indication for Yescarta (axicabtagene ciloleucel).- Flcube.com
