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.<\/p>\n\n\n\n
Pandemic-Related Drug Approvals and Clinical-Value Oriented Innovations<\/strong>
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.<\/p>\n\n\n\n