監(jiān)管科學(xué)是近年發(fā)展形成的前沿學(xué)科，受到世界科學(xué)界和管理界的重視。在醫(yī)藥產(chǎn)品開(kāi)發(fā)和評(píng)價(jià)中，所用的科學(xué)技術(shù)必須進(jìn)行改進(jìn)，目前主要從8 個(gè)主要領(lǐng)域來(lái)發(fā)展監(jiān)管科學(xué)：（1）毒理學(xué)的現(xiàn)代化；（2）推動(dòng)臨床評(píng)價(jià)和個(gè)體化醫(yī)療的創(chuàng)新；（3）創(chuàng)造新的方法以改進(jìn)產(chǎn)品的生產(chǎn)工藝并提高產(chǎn)品質(zhì)量；（4）確保食品藥品監(jiān)管機(jī)構(gòu)已經(jīng)為創(chuàng)新技術(shù)的評(píng)估做好充分準(zhǔn)備；（5）借助信息科學(xué)利用好各種數(shù)據(jù)；（6）推行以預(yù)防為主的食品安全體系；（7）加快制定醫(yī)療對(duì)策以抵御各種威脅；（8）進(jìn)一步發(fā)展社會(huì)和行為科學(xué)以幫助消費(fèi)者在選擇產(chǎn)品時(shí)做出知情決策。從轉(zhuǎn)化研究角度，從監(jiān)管科學(xué)到科學(xué)監(jiān)管的發(fā)展，監(jiān)管科學(xué)面臨的挑戰(zhàn)和機(jī)遇、監(jiān)管科學(xué)與科學(xué)監(jiān)管的關(guān)系等方面進(jìn)行簡(jiǎn)要論述，并對(duì)我國(guó)監(jiān)管科學(xué)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.