摘要
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。
According to USA FDA, and EU EC, EMEA, and FV0 related regulations, this paper introduced the basic registra- tion requirements of Chinese Traditional Medicine to apply marketing authorization in USA and EU.
出处
《天津药学》
2007年第2期44-45,71,共3页
Tianjin Pharmacy
