在當(dāng)前國際制藥技術(shù)出現(xiàn)重大創(chuàng)新和變革、藥品研發(fā)技術(shù)信息化和數(shù)字化程度不斷發(fā)展，以及新型冠狀病毒肺炎（COVID-19）疫情大流行的背景下，歐盟委員會為滿足未竟臨床需求、激勵行業(yè)創(chuàng)新、增強(qiáng)監(jiān)管系統(tǒng)應(yīng)變能力、鞏固歐盟藥品監(jiān)管體系國際地位，于2020年底發(fā)布了《歐洲藥物戰(zhàn)略》（Pharmaceutical Strategy for Europe，PSE）。PSE被視為歐洲未來5年衛(wèi)生政策的“基石”，對歐洲制藥領(lǐng)域發(fā)展和管理具有重要指導(dǎo)意義。通過對PSE制定背景及發(fā)展戰(zhàn)略目標(biāo)、具體舉措等內(nèi)容進(jìn)行梳理分析，并結(jié)合中國COVID-19疫情防控與行業(yè)發(fā)展、藥品科學(xué)監(jiān)管與鼓勵創(chuàng)新等實(shí)際工作提出政策建議。

Under the background of major innovations and changes in international pharmaceutical technology, the continuous development of informatization and digitalization of drug R & D, technology, and the COVID-19 pandemic, the European Commission (EC) issued the pharmaceutical Strategy for Europe (PSE) at the end of 2020 in order to meet the unfinished clinical needs, stimulate industry innovation, enhance the adaptability of the regulatory system, and consolidate the international status of the EC drug regulatory system. PSE is regarded as the "cornerstone" of European health policy in the next five years, which has important guiding significance for the development and management of European pharmaceutical industry. This paper combs and analyzes the background, development strategic objectives and specific measures of PSE, and puts forward policy suggestions in combination with the actual work of China's epidemic prevention and control and industry development, pharmaceutical scientific supervision and encouraging innovation.