Research on the Current Status of Registration and Clinical Trials for Class 3 Chemical Drugs in China and Its Implications

OBJECTIVE To analyze the current status of registration and clinical trial initiation for class 3 chemical drugs in China from 2016 to 2024, summarize the patterns in clinical trial requirements for their marketing approval, and provide policy recommendations.

METHODS Based on common industry classification practices, descriptive statistical analysis was used to examine the registration and clinical trial implementation status of class 3 chemical drugs in China from 2016 to 2024.

RESULTS A total of 2000 products were approved for marketing. Among them, 76.7% of “true class 3 chemical drugs” underwent confirmatory clinical trials, while the majority of “semi-true class 3 chemical drugs”(90.7%) and “domestic marketed class 3 chemical drugs”(97.8%) approved for marketing did not undergo such trials. However, among the products approved for clinical trials, a significant proportion of “true class 3 chemical drugs”(42.8%) and “semi-true class 3 chemical drugs”(47.1%) were also observed.

CONCLUSION  “True class 3 chemical drugs” and “semi-true class 3 chemical drugs” with different indications generally require implementing confirmatory clinical trials. For other circumstances of “semi-true class 3 chemical drugs”, necessary clinical trials shall be conducted based on actual conditions. “Domestic marketed class 3 chemical drugs” generally do not require implementing confirmatory clinical trials. It is recommended to refine the drug registration classification and improve clinical trial requirements for different subcategories of class 3 chemical drugs.