兽医药品 meaning in English
veterinary medicament
Examples
- Administration of veterinary biologic and animal drug in the united states of america is belongs to two agency : aphis - cvb and fda - cvm . mostly the legal basis for product licensure include : vst acts , 9cfr , vsm , federal food , drug , and cosmetic act , 21cfr etc . the european medicines evaluation agency for product used in animal is emea - cvmp . the legal basis on three director ( 81 / 851 / eec , 81 / 852 / eec , 2001 / 82 / eec ) and one regulation ( 2309 / 93 / eec )
美国兽用生物制品和兽用药品归两个部门管理,兽用生物制品由美国农业部动植物检疫局( aphis )下属的兽医生物制品中心( cvb )负责,兽用药品由美国健康和人类服务部食品与药物管理局( fda )下属的兽医药品中心( cvm )负责;产品注册的有关法律法规主要包括生物制品的《病毒-血清-毒素法》 ( vstacts ) 、 《联邦法规9 》 ( 9cfr )及一些规章如美国兽医局发布的《美国农业部兽医服务局规章》 ( vsm )等,兽用药品的《联邦食品、药品与化妆品法》和《联邦法规21 》等。 - The requirements of dossier contents for licensing application are different in u . s . a , eu and china . this dissertation explains the dossier detailedly include : the dossier requirements of veterinary domestic , import product and animal drug product in u . s . a . the dossier requirements of immunological medical product , medicine product and unimmunological medical product in eu . and chinese dossier requirement of domestic new veterinary biological and drug product , import eterinary biological and drug product
本文详细介绍了美国兽用生物制品中国内产品和进口产品的注册申报材料及兽用药品的材料要求;介绍了欧盟对免疫用兽医药品和兽医药品、非免疫用兽医药品的书写格式和内容的要求;同时详细说明了中国对申报国内新兽用生物制品和新兽药、进口兽用生物制品和兽药的注册申报材料的项目要求。