药品监管科学发展十年(2010—2020)回顾

A review of development of drug regulatory science in past 10 years(2010-2020)

自2010年国际上倡导发展监管科学以来的10年间,对监管科学这一新学科的发展及其研究开发新的工具、标准和方法来评估受监管产品的安全性、有效性、质量和性能,为指导药物创新、评估、质量、安全性和有效性产生了积极作用。从6方面回顾和论述:(1)世界药品监管科学10年发展概况;(2)国际政府-产业-科学研究3方面的积极合作,特别是非政府机构推进国家管理部门重视监管科学的发展;(3)结合国情重视中药研发的监管科学建设;(4)推进生物技术药物监管科学的最新发展动向;(5)中国药品监管科学行动计划对提高监管水平的新引擎作用;(6)在疫情特殊时期监管科学为防控新冠肺炎(COVID-19)所获得的成绩和存在的问题。最后,为推进监管科学在我国的发展提出10条建议。

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.