中国3类化药注册与开展临床试验现状研究及启示

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

关键词:  化学药品注册分类  3类化药  临床试验要求  验证性临床试验

Key words:  Registration Classification of Chemical Drugs  Class 3 Chemical Drugs  Requirements for drug clinical trials  Confirmatory clinical trials

摘要:

目的 本文通过分析2016年至2024年中国3类化药注册与开展临床试验现状，总结中国3类化药上市所需开展临床试验要求的规律，并提出政策建议。方法 结合产业界实践中的通行分类方法，采用描述性统计分析法分析中国2016至2024年3类化药注册与开展临床试验现状。结果 共上市2000个产品，其中“真3类化药”有76.7%开展验证性临床试验；多数批准上市的“半真3类化药”（90.7%）与“境内已有上市型3类化药”（97.8%）未开展验证性临床试验；但同时批准临床试验的产品中，亦有较大比例的“真3类化药”（42.8%）和“半真3类化药”（47.1%）。结论 “真3类化药”与适应症不同的“半真3类化药”通常需开展验证性临床试验；其他情形的“半真3类化药”需结合实际情况分析开展必要的临床试验；“境内已有上市型3类化药”通常无需开展验证性临床试验。建议针对3类化药的不同细分情形细化药品注册分类并完善临床试验要求。

Abstract:

ABSTRACT: OBJECTIVE This study analyzes the current status of registration and clinical trial initiation for Class 3 Chemical Drugs in China from 2016 to 2024, summarizes the patterns in clinical trial requirements for their marketing approval, and provides 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 2,000 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 semi-real Class 3 Drugs under other circumstances, 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.