摘要
随着我国药品审评审批制度改革的不断推进,药品监管科学与事业的发展进入了新时代。本文结合改革创新的时代背景,概述我国目前的药品监管模式及其存在的缺陷,分析当前药品监管的形势,对药品监管模式进行探讨,并对欧美国家的药品监管情况作了简要介绍。本文还介绍了生物药新的监管模式的初步实践情况,对药品监管模式的创新探索作了展望。
Along with the comprehensive progress made in the reform of the drug review and approval system in China, the development of the science and undertakings of drug regulation has been entered into a new era. The current regulation mode in China and its imperfections are summarized by combining the era backgrounds of reform and innovation, the current situation of drug regulation in China is analyzed and the advantages and disadvantages of this drug regulation mode are discussed as well as the drug regulation status in European Union and the United States is briefy introduced. Meanwhile, the tentative practice of new regulation mode for biologics in China is introduced, and the innovative explorations of drug regulation mode is also prospected.
出处
《上海医药》
CAS
2018年第3期5-9,13,共6页
Shanghai Medical & Pharmaceutical Journal
