国家食品药品监督管理总局及内设机构英文译名与药品注册英语术语

一、国家食品药品监督管理总局
China Food and Drug Administration,缩写:CFDA

二、内设机构

  1. 办公厅
    General Office
  2. 综合司(政策研究室)
    Comprehensive Department(Office of Policy Research)
  3. 法制司
    Department of Legal Affairs
  4. 食品安全监管一司
    Department of Food Safety Supervision I
  5. 食品安全监管二司
    Department of Food Safety Supervision II
  6. 食品安全监管三司
    Department of Food Safety Supervision III
  7. 药品化妆品注册管理司(中药民族药监管司)
    Department of Drug and Cosmetics Registration (Department of TCMs and Ethno- Medicines Supervision)
  8. 医疗器械注册管理司
    Department of Medical Device Registration
  9. 药品化妆品监管司
    Department of Drug and Cosmetics Supervision
  10. 医疗器械监管司
    Department of Medical Device Supervision
  11. 稽查局
    Bureau of Investigation and Enforcement
  12. 应急管理司
    Department of Emergency Management
  13. 科技和标准司
    Department of Science,Technology and Standards
  14. 新闻宣传司
    Department of Media andPublicity
  15. 人事司
    Department of Human Resources
  16. 规划财务司
    Department of Planning and Finance
  17. 国际合作司(港澳台办公室)
    Department of International Cooperation (Office of Hong Kong, Macao and Taiwan Affairs)

三、药品注册英语术语(Glossary)

  • Regulatory Affairs (RA):药政事务
    drugauthority:药政当局
    investigation and research before project approval:立项前的调研
    Market Authorization (MA):上市许可
    post-approval commitment study:上市后的承诺研究
  • post-approval variation application:补充申请
    lifecycle:生命周期
    Chemistry, Manufacturing, and Controls (CMC):药品的化学、生产和控制
    cross-functional teams:公司内部各部门
    look at the big picture:从大局考虑
  • think strategically:进行战略性思考
    risks and benefits:风险和获益
    Food and Drug Administration (FDA):美国食品药品监督管理局
    European Medicines Agency (EMA):欧洲药品管理局
    International Multi-center Clinical Trial (IMCT):国际多中心临床试验
    Bioequivalence study (BE study):生物等效性试验
  • genericdrug:仿制药
    Center for Drug Evaluation (CDE):SFDA下属的药品审评中心
    Quality by Design (QbD):质量源于设计
    CMC Pilot Program:FDA在业内开展的关于QbD的试点研究
    early launch:早日上市
  • design space:设计空间
    Business Development (BD):业务发展部门
    Imported Drug License (IDL):进口药品注册证
    Manufacturing License (ML):生产许可证
    Clinical Trial Permission (CTP):临床试验批件
  • Active Pharmaceutical Ingredient (API):原料药
    Orange Book:橙皮书
    business value:商业价值
    the Pharmacopoeia of the People's Republic of China(ChP):中国药典
    the United States Pharmacopoeia (USP):美国药典
    the European Pharmacopoeia (Ph. Eur.或EP):欧洲药典
  • List of Essential Drugs (EDL):基本药物目录
    Reimbursement Drug List (RDL):医保目录)
    typing error:打印错误
    slip of the pen:笔误
    Drug Master File (DMF):药物主文件
  • Certificate of Analysis (CoA):检验报告
    Marketing(MKT):市场部
    market share:市场占有率
    sales volume:销量
    investigator brochure (IB):研究者手册
  • protocol:临床试验方案
    priority:优先度
    package insert (PI):说明书
    labeling:包装标签
    Patient Information Leaflet (PIL):患者使用的说明书
    Summary of Product Characteristics (SmPC,SPC):产品特性摘要
    foil:铝箔
  • carton:装药品的小盒
    shipping label:运输包装标签
    Medical:医学部
    provincial drug administration (PDA):省级药监局,包括省、自治区和直辖市药品监督管理部门
    Institute for Food and Drug Control:药检所
  • National Institute for the Control of Pharmaceutical and Biological Products (NICPBP):中国药品生物制品检定所,简称“中检所”
    supplementary dossier:补充资料
    approval letter:注册批件
    out of specification (OOS):超出标准、不合格
  • adverse effect (AE):不良事件
    trial waiver:减免临床试验
    Clinical:临床部门
    Commercial:商业部门
    new chemical entity (NCE):新化学实体
  • off-labeluse:标签外使用
    patient pool:患者库
    deadline:最后期限
    global trial:全球性的临床试验,即国际多中心临床试验
    regional trial:区域性的临床试验