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Clinical Pharmacology in China: Seven Decades of Progress in Discipline Development and Education
Guo-Xiang Hao1, Yue Zhou1, Bo-Hao Tang2
1Department of Clinical Pharmacy, Institute of Clinical Pharmacology, Key Laboratory of Chemical Biology (Ministry of Education), State Key Laboratory of Discovery and Utilization of Functional Components in Traditional Chinese Medicine, School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China.
Abstract:
Clinical pharmacology serves as the central discipline supporting rational clinical medication, innovative drug research, and full-lifecycle pharmaceutical supervision. Domestic clinical pharmacology research began in the 1950s, and the field entered a period of rapid development after 1979 across three phases. This study sorts domestic disciplinary milestones and analyzes three key datasets: among the 1949 registered drug clinical trial institutions nationwide, nearly 50% are located in East China; investigational new drug applications surged from 446 (2012) to 3516 (2025); and the Center for Drug Evaluation issued 631 technical guidelines. The National Natural Science Foundation set up an independent clinical pharmacology discipline classification in 2015. The multi-tiered educational system is further elaborated: the transitional 5-year pharmacy (clinical pharmacology direction) track, standardized 5-year clinical pharmacy undergraduate programs, and clinical pharmacology-oriented postgraduate research sub-disciplines under pharmacy-related majors. Although the field has built a complete framework covering basic research, clinical practice and regulatory evaluation, critical bottlenecks persist. Clinical pharmacology is not listed as an independent major in national undergraduate and postgraduate catalogues, resulting in uneven educational standards, insufficient industry-academia integration, and striking regional gaps in disciplinary resources between eastern and inland areas. China's transitional undergraduate training model and phased regulatory improvements provide practical references for pharmaceutical regulators and educators worldwide. Targeted optimization strategies are proposed to construct unified tiered educational systems, deepen cross-stakeholder collaborative innovation, and balance regional disciplinary layouts. The sound and balanced development of clinical pharmacology will continuously advance standardized clinical medication, accelerate domestic new drug innovations, and strengthen national public health protection.
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