Drug regulatory science is a frontier interdisciplinary subject formed internationally in recent decades, centering on developing new tools, new standards and new methods to support drug regulatory decision-making; as for China, the construction of laws, regulations and systems with Chinese characteristics also falls in the scope of research. Drug regulatory science is an important basis for promoting the transformation of innovative drugs and therapies, ensuring drug safety, and safeguarding people’s life and health.

In 2016, the CPC Central Committee and the State Council released the Outline of the “Healthy China 2030” Plan (the Outline), which is the first national medium- and long-term strategic plan in the field of health since the founding of the People’s Republic of China, designed to comprehensively address major and long-term health issues at the national strategic level, make all-out efforts to build a healthy China, and improve the health of the people. The Outline clearly sets out to achieve the goal of becoming a powerful pharmaceutical country by 2030. In doing so, regulation shall go first. Guided by the goal of “making China a powerful pharmaceutical country by 2030”, the National Medical Products Administration has formulated a strategic roadmap for regulatory science in China, and officially launched the China Drug Regulatory Science Action Plan in April 2019. Based on the discipline development in the new century, the construction of a world-class university and the major strategic needs of the state, Tsinghua University gives full play to its experience and resource advantages in the fields of education and scientific research, and established the Institute of Drug Regulatory Science, Tsinghua University in November 2019 for development in drug regulatory science as a discipline.

The research team of drug regulatory scientific at the School of Pharmaceutical Sciences practices the university’s strategic planning for development: based on China’s reality, pay attention to realistic theoretical and practical issues, focus on the future regulatory challenges, and carry out systematic and forward-looking research around three themes: “regulatory science innovation tools, standards and methods”, “regulatory policies and regulations”, and “regulatory model innovation and regulatory capacity improvement”; cultivate professional interdisciplinary talents in regulatory science with an international perspective; and build an authoritative national think tank with international influence to provide scientific suggestions for decision making that meet China’s national conditions and development needs, contributing the wisdom of Tsinghua University for the realization of the goal of “making China a powerful pharmaceutical country by 2030” and the implementation of China Drug Regulatory Science Action Plan.

Academic Leader of Drug Regulatory Science at School of Pharmaceutical Sciences, Tsinghua University:

Yang Yue

Yang Yue is the first doctor of pharmacy in the field of pharmacy administration (Master and Doctoral Supervisor: Professor Su Huaide) in China. She previously served as a professor and doctoral supervisor at Shenyang Pharmaceutical University, and joined the School of Pharmaceutical Sciences at Tsinghua University in 2020 as a research fellow and doctoral supervisor.