Drug regulatory science is a cutting-edge task in the field of drug regulation that has received much attention from the international community in recent years. Currently, different countries and regions have different foundations for drug regulatory industries, are in different stages of development, and face different prominent issues. Therefore, the focus of drug regulatory science and the problems that need to be solved are also different. The origin of drug regulatory science suggests that we should deeply consider the emergence and development of drug regulatory science from the perspective of the arrival of a new era and the emergence of new forces. The definition and characteristics of drug regulatory science suggest that it is a practical science that solves prominent problems and directly serves regulatory decision-making, and future studies should focus on drug regulation rules, develop new regulatory tools, standards and methods, and cultivate new theories, regulations and mechanism.