专论国际药品监管科学发展概况.pdfVIP

Drug Evaluation Research 第40 卷 第8 期 2017 年8 月 • 1029 • 【专 论 】 国际药品监管科学发展概况 刘昌孝1, 2 1. 天津药物研究院新药评价有限公司，天津 300193 2. 天津滨海食品药品监管科学研究中心，天津 300193 摘 要：食品药品监管科学是近十几年发展形成的前沿学科，受到世界科学界和管理界的重视。食品药品监管科学不仅研究 制定医药创新产品的监管政策、监管法规构建方法、产品创新技术策略以及各类创新产品的标准等，而且研发评估医药创新 产品安全性、有效性、质量及性能和制定科学监管法规具有重要意义，特别在医药产品开发和评价和产品研发、生产、流通 监管中具有重要的科学意义和应用价值。分析回顾了国际食品药品监管科学的发展概况，介绍国际药品监管和监管科学发展 的情况，希望对该新兴学科发展研究者和管理者获益。 关键词：监管科学；科学监管，食品；药品；研究者；管理者 中图分类号：R965.1 文献标志码：A 文章编号：1674 - 6376(2017)08 - 1029 - 0 15 DOI: 10.7501/j.issn.1674-6376.2017.08.001 Development of drug regulatory science in the world LIU Chang-xiao1, 2 1. Tianjin Research Center of New Drug Evaluation, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China 2. Tianjin Binhai Center for Food and Drug Regulatory Science Research, Tianjin 300193, China 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 RD 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 articl