In recent years,the drug regulatory authorities of China have been proactive in implementing various measures aimed at expediting the marketing approval of domestically developed innovative drugs and imported drugs already marketed overseas.This is done to address the urgent medical needs of the vast majority of patients.Through the implementation of conditional approval procedures,breakthrough treatment drug identification,priority review and approval and other accelerated drug review and approval paths,it provides a strong guarantee for the accelerated innovation of domestic anti-tumor drugs,and effectively promotes the research and development process of anti-tumor drugs.Concurrently,the ongoing advancement of drug regulatory science has offered solid technical backing for drug research and development.The gradual establishment and refinement of China's anti-tumor drug evaluation system have provided more scientific and standardized guidance for drug evaluation and development.This paper presents a retrospective review of the evolution and innovation of evaluation standards in China over the past decade.The drug regulatory authorities will persist in promoting the regulation of anti-tumor drug innovation,paying particular attention to rare tumors and pediatric tumors in the realm of drug research and development in future.This will be achieved by refining the review,examination,and approval system and enhancing the efficiency of evaluation reviews,striving to ensure that tumor patients can access more high-quality,safe,and effective treatment options.
关键词
药品监管/抗肿瘤药/审评审批/技术标准
Key words
drug regulatory/anti-tumor drugs/review and approval/technical standards
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