The Center for Drug Evaluation (CDE) has released its comprehensive 2022 annual drug review report, shedding light on the regulatory activities and statistics from the past year. This report provides a detailed account of the drug approval process amidst the ongoing COVID-19 pandemic and beyond.
Pandemic-Related Drug Approvals and Clinical-Value Oriented Innovations
In response to the COVID-19 pandemic, the CDE approved a recombinant COVID-19 protein vaccine (CHO cells) and granted marketing approval for 4 COVID-19 therapies. Additionally, 38 antipyretic and antitussive drugs for symptomatic treatment of COVID-19 were conditionally approved. The CDE also focused on clinical-value oriented drug innovation, with the approval of 21 novel drugs, including 3 first-in-class products. A record 1024 new drug marketing review reports were disclosed, along with 66 pediatric drugs and 10 new traditional Chinese medicines (TCMs). The CDE also released a total of 61 sets of guidelines, encouraging drug development in the Yangtze River Delta and Greater Bay Area. In the 2022 evaluation of the National Regulatory System (NRA) for Vaccines by the World Health Organization, China’s drug registration and marketing licensing sector received a full score of 100 and a maximum rating of 4.
Market Filings and Technical Reviews
In 2022, the CDE accepted a total of 12,368 market filings, marking a 6.09% increase year-on-year (YOY). Notably, 3,067 were directly approved under the national bureau’s name without technical review, a 26.58% YOY increase. A total of 9,301 cases required technical review, including 7,054 chemical drug filings (+3.92%), 1,820 biological product filings (-8.95%), and 421 TCM filings (-5.18%). The CDE also processed 6 filings for drug and device combination products.
Filing Category Analysis
The CDE accepted 2,244 new drug clinical filings, a 6.97% YOY increase; 334 filings for new drug marketing licenses, up 14.14% YOY; 2,317 filings for drugs with the same name and formula, as well as chemical generic drugs, marking a 29.37% increase; 835 filings for generic quality and efficacy consistency evaluation (-8.04%); and 3,020 supplementary filings (-8.01%).
Pandemic’s Impact on Drug Review and Approval
The pandemic’s impact led to a lag in drug review and approval work. In 2022, 11,365 cases were closed, a 5.94% YOY decrease, while 2,064 INDs were passed, down 2.09% YOY; 269 NDAs were recommended for approval, a 16.72% YOY decrease.-Fineline Info & Tech
