[關(guān)鍵詞]
[摘要]
食品藥品監(jiān)管科學是近十幾年發(fā)展形成的前沿學科,受到世界科學界和管理界的重視。食品藥品監(jiān)管科學不僅研究制定醫(yī)藥創(chuàng)新產(chǎn)品的監(jiān)管政策、監(jiān)管法規(guī)構(gòu)建方法、產(chǎn)品創(chuàng)新技術(shù)策略以及各類創(chuàng)新產(chǎn)品的標準等,而且研發(fā)評估醫(yī)藥創(chuàng)新產(chǎn)品安全性、有效性、質(zhì)量及性能和制定科學監(jiān)管法規(guī)具有重要意義,特別在醫(yī)藥產(chǎn)品開發(fā)和評價和產(chǎn)品研發(fā)、生產(chǎn)、流通監(jiān)管中具有重要的科學意義和應(yīng)用價值。分析回顧了國際食品藥品監(jiān)管科學的發(fā)展概況,介紹國際藥品監(jiān)管和監(jiān)管科學發(fā)展的情況,希望對該新興學科發(fā)展研究者和管理者獲益。
[Key word]
[Abstract]
Regulatory science of food and drug is a cutting-edge science in recent years. The development of regulatory science and management communities attach importance. The regulatory science is not only research and control the development of pharmaceutical innovation products,but also is useful for regulatory policies, regulatory laws and regulations to build methods, product innovation and technical strategies and various innovative product standards, and R&D assessment of pharmaceutical innovation product safety, effectiveness, quality and performance and scientific regulation are great significance. Especially in the pharmaceutical product development and evaluation and product development, production, circulation supervision has important scientific significance and application value. This paper analyzes the development of international food and drug regulatory science. This article describes the development of the international drug regulatory and regulatory science, and it hopes to benefit researchers and managers from emerging disciplines.
[中圖分類號]
[基金項目]