1) new drug approval
新药审评
1.
This article reviews rectification and protection of Chinese patent medicines,establishment and improvement of the new drug approval,and historical evolution of the pharmacopoeia of the People s Republic of China.
通过回顾我国传统中成药品种的整顿工作,中成药品种的保护工作,新药审评方法的建立和不断完善以及中国药典的历史沿革和发展,对我国中成药质量标准化建设的现状进行了分析;剖析了在新的历史时期我国中成药质量标准化建设所面临的问题和挑战;并提出了使中成药走向世界、与国际接轨的策略和中医药工作者今后的努力方向。
3) new drug evaluation
新药评价
1.
Probe into teaching reform of new drug evaluation for biotechnological major;
生物技术专业新药评价课程教学改革的探索
2.
Application of medical ethical education in new drug evaluation teaching;
寓医学科研道德教育于新药评价教学中
3.
Practice and exploration of summer school for graduates in new drug evaluation
新药评价研究生暑期学校的实践与探索
4) innovation appraisal
创新性评审
5) drug utilization review
药物利用评审
6) EMEA
欧盟药品审评局
1.
According to USA FDA,and EU EC,EMEA,and FVO related regulations,this paper introduced the basic registration requirements of Chinese Traditional Medicine to apply marketing authorization in USA and EU.
参阅美国食品药品监督管理局(FDA,Food and Drug Administration);欧盟委员会(EC,European Commis-sion);欧盟药品审评局(EMEA,The European Agency for the Evaluation of Medicinal Products)及欧盟食品兽医办公室(FVO,Food and Veterinary Office)有关法律法规文件,就中药在欧美国家申请上市注册的基本要求做简要介绍。