自2010年國(guó)際上倡導(dǎo)發(fā)展監(jiān)管科學(xué)以來(lái)的10年間，對(duì)監(jiān)管科學(xué)這一新學(xué)科的發(fā)展及其研究開發(fā)新的工具、標(biāo)準(zhǔn)和方法來(lái)評(píng)估受監(jiān)管產(chǎn)品的安全性、有效性、質(zhì)量和性能，為指導(dǎo)藥物創(chuàng)新、評(píng)估、質(zhì)量、安全性和有效性產(chǎn)生了積極作用。從6方面回顧和論述：（1）世界藥品監(jiān)管科學(xué)10年發(fā)展概況；（2）國(guó)際政府-產(chǎn)業(yè)-科學(xué)研究3方面的積極合作，特別是非政府機(jī)構(gòu)推進(jìn)國(guó)家管理部門重視監(jiān)管科學(xué)的發(fā)展；（3）結(jié)合國(guó)情重視中藥研發(fā)的監(jiān)管科學(xué)建設(shè)；（4）推進(jìn)生物技術(shù)藥物監(jiān)管科學(xué)的最新發(fā)展動(dòng)向；（5）中國(guó)藥品監(jiān)管科學(xué)行動(dòng)計(jì)劃對(duì)提高監(jiān)管水平的新引擎作用；（6）在疫情特殊時(shí)期監(jiān)管科學(xué)為防控新冠肺炎（COVID-19）所獲得的成績(jī)和存在的問(wèn)題。最后，為推進(jìn)監(jiān)管科學(xué)在我國(guó)的發(fā)展提出10條建議。

In the 10 years since the international promotion of the development of regulatory science in 2010, the development of the new discipline of regulatory science and its research and development of new tools, standards and methods to evaluate the safety, effectiveness, quality and performance of regulated products have played a positive role in guiding drug innovation, evaluation, quality, safety and effectiveness. This paper reviews and discusses from six aspects:(1) the 10-year development of world drug regulatory science; (2) the international cooperation in government-industry-scientific research, especially in promoting the development of scientific supervision and regulation by national regulatory authorities by non-governmental organizations; (3) Attach importance to the supervision and scientific construction of TCM research and development; (4) To promote recent developments in the science regulation of biotechnology products; (5) The national drug regulatory agency organized the launch and implementation of the scientific action plan for drug supervision and control during one year.; and (6) To monitor the achievements and science problems of in the prevention and control of covid-19 at a special time. Finally, it puts forward ten suggestions for promoting the advancing development of regulatory science in China.