完善中国3类化药临床试验要求的质性研究

A Qualitative Study on Refining Clinical Trial Requirements for Class 3 Chemical Drugs in China

关键词:  化学药品注册分类  3类化药  临床试验要求  种族敏感性  桥接研究

Key words:  Registration  Classification of  Chemical Drugs, Class 3 Chemical  Drugs, Requirements  for drug  clinical trials, Sensitivity  to Ethnic  Factors, Bridging  Study

摘要:

目的 本文通过质性研究法，结合案例分析提出完善中国3类化药上市所需开展临床试验要求的建议。方法 结合产业界实践中的通行分类方法，将3类化药分为“真3类化药”“半真3类化药”“境内已有上市型3类化药”，使用质性研究法分析各细分情形3类化药上市所需开展的临床试验要求。结果 “真3类化药”与适应症不同的“半真3类化药”一般需开展验证性临床试验；结构不同、剂型不同与复方“半真3类化药”需考虑桥接路径；处方不同、规格不同的“半真3类化药”与“境内已有上市型3类化药”一般无需开展验证性临床试验。结论 支持3类化药上市所需开展的临床试验与境内已掌握的临床安全性与有效性数据基础相匹配。建议针对3类化药的不同细分情形完善技术要求。

Abstract:

ABSTRACT: OBJECTIVE This study employs qualitative research methods and 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 are 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 require 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 domestic marketed Class 3 Chemical Drugs, generally do not require implementing confirmatory clinical trials. CONCLUSION The clinical trial requirements for marketing Class 3 Chemical Drugs align with the existing domestic clinical safety and efficacy data. It is recommended to refine technical guideline for different subcategories of Class 3 Chemical Drugs.