監(jiān)管科學是近年發(fā)展形成的前沿學科，受到世界科學界和管理界的重視。在醫(yī)藥產品開發(fā)和評價中，所用的科學技術必須進行改進，目前主要從8 個主要領域來發(fā)展監(jiān)管科學：（1）毒理學的現(xiàn)代化；（2）推動臨床評價和個體化醫(yī)療的創(chuàng)新；（3）創(chuàng)造新的方法以改進產品的生產工藝并提高產品質量；（4）確保食品藥品監(jiān)管機構已經為創(chuàng)新技術的評估做好充分準備；（5）借助信息科學利用好各種數(shù)據(jù)；（6）推行以預防為主的食品安全體系；（7）加快制定醫(yī)療對策以抵御各種威脅；（8）進一步發(fā)展社會和行為科學以幫助消費者在選擇產品時做出知情決策。從轉化研究角度，從監(jiān)管科學到科學監(jiān)管的發(fā)展，監(jiān)管科學面臨的挑戰(zhàn)和機遇、監(jiān)管科學與科學監(jiān)管的關系等方面進行簡要論述，并對我國監(jiān)管科學的發(fā)展提出建議。

Regulatory science is a cutting-edge science in recent years. The science and management communities attach importance to its development. The modern science and technology used in the development and evaluation of medicinal products conducted a thorough reform, with the current mainly from eight major areas to develop regulatory science: (1) modernize toxicology to enhance product safety, (2) stimulate innovation in clinical evaluation and personalized medicine to improve product development and patient outcomes, (3) support new approaches to improve product manufacturing and quality, (4) ensure food drug administration readiness to evaluate innovative emerging technologies, (5) harness diverse data through information sciences to improve health outcomes, (6) implement a new prevention-focused food safety system to protect public health, (7) facilitate development of medical countermeasures to protect against threats to global health and security, and (8) strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products. In this review on translational research, from a regulatory science to scientific regulation, authors discussed the development of science and regulation, regulatory challenges and opportunities facing the scientific, regulatory relationship between science and the scientific supervision of other aspects briefly discussed, and some suggestions for the development of regulatory science in China.