Asian Journal Of Social Pharmacy

Objective To study the development of regulatory science in the USA and draw some useful experience, so as to provide suggestions for the development of regulatory science in China. Methods The policy documents of the Food and Drug Administration of USA and the literature and data of relevant USA academic institutions were searched, the development history and latest progress of regulatory science in the USA were elaborated. Compared to the current status of regulatory science in China, some suggestions to promote its development were put forward. Results and Conclusion Currently, regulatory science has become increasingly important for food, drug and medical devices testing and regulatory control. The Food and Drug Administration of USA attaches great importance to the development of regulatory science, releasing several regulatory science strategic plans, funding the Centers of Excellence in Regulatory Science and Innovation, cooperating with universities and enterprises to promote the construction of regulatory science disciplines and targeted training of talents. The development of regulatory science in China started relatively late and it still has a certain gap with the USA. Therefore, the top-level design of regulatory science should be strengthened and the strategic goals of regulatory science should be clarified. In addition, more attention should be paid to cooperation with universities and research institutes, some relevant disciplines should be set up, and the high-quality regulatory science personnel should be cultivated.

regulatory science, construction of discipline, the Food and Drug Administration, personnel training