OBJECTIVE To employ qualitative research methods combined with case analysis to propose recommendations for refining the clinical trial requirements for the marketing approval of class 3 chemical drugs in China.

METHODS Based on common industry classification practices, class 3 chemical drugs were categorized into “true class 3 chemical drugs” “semi-true class 3 chemical drugs” and “domestically marketed class 3 chemical drugs”. Qualitative research methods were used to analyze the clinical trial requirements for marketing approval across these subtypes of class 3 chemical drugs.

RESULTS “True class 3 chemical drugs” and “semi-true class 3 chemical drugs” with different indications generally required implementing confirmatory clinical trials. “Semi-true class 3 chemical drugs” with structural differences, different dosage forms, or combination formulations should consider bridging pathways. “Semi-true class 3 chemical drugs” with different formulations or strengths, as well as “domestically marketed class 3 chemical drugs”, generally did not require implementing confirmatory clinical trials.

CONCLUSION The clinical trials required for the marketing of class 3 chemical drugs shall be consistent with the available domestic clinical safety and efficacy data of such drugs in China. It is recommended to improve the technical requirements for different subcategories of class 3 chemical drugs.