药学英语07 Unit Eight2014课件.ppt

Pharmaceutical Administration Contents Special Terms (I) abbreviated new drug application (ANDA) （仿制药）简化新药申请 abuse 滥用 accelerated review 加速”审批“ accept and register 受理与立案 acceptance 验收，接收 adopted name 药品通用名 Special Terms (II) adulterate/ adulteration 掺假 adverse drug reaction (ADR) 药品不良反应 approval of a new production 新药生产审批 approve and award a certificate 批准与授予证书 biological products 生物制品，生物产品 biologics 生物技术药物 Special Terms (III) biostatistics 生物统计学 blood bank 血库 Bureau 局，处 CDER 医药评价与研究中心 CFSAN 食品安全及应用营养中心 clinical studies/trials 临床试验 Special Terms (IV) compound preparation 复方制剂 contract 合同 Control of Clinical Trial Act 临床试验管理法 cosmetics 化妆品 counterfeit drug 假药 Criminal Law 刑法 Special Terms (V) deputy commissioner 副局长 discipline of pharmaceutical administration 药事管理学科 Division of Poison Control 毒物控制处 drug abuse treatment monitoring 药物滥用治疗监管 drug administration 药品管理 drug approval number 药品批准文号 Special Terms (VI) drug certification 药品认证 drug classification 药品分类 drug distributor 药品经营企业 drug export license 出口药品许可证 drug license 药品注册，药品执照 drug trademark 药品商标 Special Terms (VII) establishment license （药品）营业执照 facility 设施 genuine Chinese crud drug 地道药材 Law on Medical Devices 《医疗器械法》 Law on Product Quality 《产品质量法》 Medicine Act/Law 《药品法》 Special Terms (VIII) name used to indicate past 曾用名 national drug standards 国家药品标准 package insert 药品说明书 packaging materials 包装材料 pharmaceutical administration (science) 药事管理（学） Pharmacopoeia of the People’s Republic of China 《中华人民共和国药典》 Special Terms (IX) Pharmacy Administration Committee 药事管理委员会 quality control (QC) 质量控制 Regulation for Implementation of the Drug Administration Law of the People’s Republic of China 《中华人民共和国药品管理实施条例》 specification 规格 withdrawal syndrome 截断症状 Texts Text A: GMP What is GMP? Paragraph 1 USA/GMP