自2010年國際上倡導發(fā)展監(jiān)管科學以來的10年間，對監(jiān)管科學這一新學科的發(fā)展及其研究開發(fā)新的工具、標準和方法來評估受監(jiān)管產品的安全性、有效性、質量和性能，為指導藥物創(chuàng)新、評估、質量、安全性和有效性產生了積極作用。從6方面回顧和論述：（1）世界藥品監(jiān)管科學10年發(fā)展概況；（2）國際政府-產業(yè)-科學研究3方面的積極合作，特別是非政府機構推進國家管理部門重視監(jiān)管科學的發(fā)展；（3）結合國情重視中藥研發(fā)的監(jiān)管科學建設；（4）推進生物技術藥物監(jiān)管科學的最新發(fā)展動向；（5）中國藥品監(jiān)管科學行動計劃對提高監(jiān)管水平的新引擎作用；（6）在疫情特殊時期監(jiān)管科學為防控新冠肺炎（COVID-19）所獲得的成績和存在的問題。最后，為推進監(jiān)管科學在我國的發(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.