RDPAC术语表.doc

RDPAC术语表RDPAC术语表 2011年09月13日/sh0628126/blog/static/1411741 8720113610472433/ 药品注册管理办法 Provisions for Drug Registration 局令 SFDA Order 总则 General Provisions 中华人民共和国药品管理法 Drug Administration Law of the Peoples Republic of China 药品管理法 Drug Administration Law 中华人民共和国行政许可法 Administrative Permission Law of the Peoples Republic of China 行政许可法 Administrative Permission Law 中华人民共和国药品管理法实施条例 Regulations for Implementation of the Drug Administration Law of the Peoples Republic of China 药品管理法实施条例 Regulations for Implementation of the Drug Administration Law 药物临床试验 drug clinical trial 药品生产 drug production 药品审批 drug approval 药品注册 Drug registration 国家食品药品监督管理局 State Food and Drug Administration 法定程序 official procedures 安全性 safety 有效性 efficacy 质量可控性 quality of the drugs 审批过程 process of review and approval 研究创制新药 the research and development of new drugs 新药 innovative drugs 疑难危重疾病 serious and life-threatening diseases 临床试验 clinical trial 药品生产和进口 production and importation of drugs 公开、公平、公正的原则 the principles of openness, fairness and justice 主审集体负责制 the system of collective responsibility of the chief reviewers 相关人员公示制 the system of publicizing and challenging relevant persons 责任追究制 the system of responsibility tracing 社会监督 social supervision 受理 acceptance 检验 inspection 审评 review 审批 approval 送达 sending 药品监督管理部门 drug regulatory department 向社会公告 make known to the general public 举行听证 hold hearings 涉及公共利益的重大许可 the matters which it deems of vital importance and involving public interests for the granting of permission 行政许可 administrative licensing 申请人 applicant 利害关系人 the interested party 陈述和申辩 statements and argues 听证 hearings 行政机关网站 official websites 注册申请受理场所 official premises for accepting application 时限 timeline 申请书示范文本 model text of the application form 已批准的药品目录 categories of approved drugs 综合信息 general information 相关单位 relevant institutions 技术秘密 technical secrets 实验数据 trial data 药品注册申请人 An applicant for drug registration 承担相应法律责任 assumes corresponding legal liability 境内申请人 domestic applicant 中国境内 within the territory of Peoples Republic of China 独立承担民事责任 independently assumes civil liability 境外申请人 overseas applicant 制药厂商 overseas drug manufacturer 进口药品注册 import drug registration 代理机构 agency 办理药品注册申请事务 handle the application for drug registration 专业知识 professional knowledge 技术要求 technical requirements 新药申请 applications for new drugs 仿制药 generic drugs 进口药品 import drugs 补充申请 supplementary applications 再注册申请 re-registration applications 未曾在中国境内上市销售的药品 drugs that have not been marketed within the territory of Peoples Republic of China 已上市药品 marketed drugs 改变剂型 changing dosage form 给药途径 route of administration 增加新适应症 claiming a new indication 仿制药申请 Application for generic drugs 生物制品 biological products 进口药品申请 application for import drugs 境外生产的药品 drugs manufactured abroad 在中国境内上市销售 marketed within the territory of the Peoples Republic of China 取消 cancellation 药品批准证明文件 drug approval document 充分可靠的研究数据 sufficient and reliable research data 对全部资料的真实性负责 be liable for the authenticity of all the dossiers submitted 引用文献 cited literature 外文资料 foreign literatures 药品行业 pharmaceutical industry 发展规划 development plan 药品的上市价值 market value of drugs 非临床研究 non-clinical studies 现场核 on-site inspection 生产现场检查 production site inspection 省、自治区、直辖市 province, autonomous region, or municipality 样品试制现场 pilot production of drug samples 处方 formula 生产工艺 manufacturing processes 用途 use 专利 patent 不构成侵权的声明 statement of non-infringement 专利权纠纷 patent dispute 专利期 expiry date of the patent 药品批准文号 drug approval number 进口药品注册证 Import Drug License 医药产品注册证 Pharmaceutical Product License 未披露的试验数据和其他数据 undisclosed drug experimental and other data 申请药品注册而进行的药物临床前研究 Pre-clinical drug study for drug registration application 药物的合成工艺 drug synthetic processes 提取方法 extraction methods 理化性质 physical and chemical properties 剂型选择 selection of dosage form 处方筛选 screening of formula 制备工艺 preparing processes 检验方法 testing methods 质量指标 quality specifications 稳定性 stability 药理 pharmacology 毒理 toxicology 动物药代动力学研究 animal pharmacokinetics 中药制剂 traditional Chinese medicine preparations 原药材 crude drugs 加工及炮制 pre-treatment and processing 细胞株 cell lines 生物组织 bio-tissues, 生物学特征 biological characteristics 保存条件 storage conditions 免疫学的研究 immunological study 药物临床前研究 pre-clinical drug study 药物非临床研究质量管理规范 Good Laboratory Practice for Non-Clinical Laboratory Studies 药物研究机构 drug research institution 试验数据 experimental data 实验动物 experimental animal 试剂 reagents 原材料 raw materials 单项试验 individual experiment 药物制剂 pharmaceutical preparations 原料药 drug substance 研究用原料药 drug substance used for the study 境外药物研究机构 overseas drug research institution 药品检验所 drug testing institute 方法学验证 methodological verification 药物研究 drug study 技术指导原则 technical guidelines 科学性 scientific feasibility 监督检查 supervise and inspect 药物的临床试验 Drug Clinical Trials 生物等效性试验 bioequivalence study 药物临床试验质量管理规范 Good Clinical Practice I期临床试验 Phase I Clinical Trial 临床药理学 clinical pharmacology 耐受程度 tolerability 药代动力学 pharmacokinetics 给药方案 administration regimen II期临床试验 Phase II Clinical Trial 治疗作用 therapeutic effectiveness 初步评价 preliminary evaluation 给药剂量方案 administrative dose regimen 随机盲法对照临床试验 randomized blind controlled clinical trial III期临床试验 Phase III Clinical Trial 足够样本量 adequate sample size IV期临床试验 Phase IV Clinical Trial 不良反应 adverse reaction 利益与风险关系 benefit-risk relationships 特殊人群 specific groups 统计学的要求 statistical requirements 最低临床试验病例数 minimum number of subjects 罕见病、特殊病种 rare or special diseases 疫苗 vaccine 菌毒种选种 bacterial or viral strain screening 动物模型 animal model 受试者 trial subjects 药品生产质量管理规范 Good Manufacturing Practice for Pharmaceutical Products 血液制品 blood products 抽查检验 sampling and testing 伦理委员会审核同意书 ethic committee approval letter 知情同意书 informed consent form 样本 template 临床试验方案 clinical trial protocol 临床试验总结报告 clinical trial final report 统计分析报告 statistical analysis report 原批准证明文件 original approval documents 严重不良事件 serious adverse event 伦理委员会 ethic committee 紧急控制措施 emergency control measures 国际多中心药物临床试验申请 international multi-center clinical trial application 预防用疫苗 preventive vaccine 非预期不良反应 unexpected adverse reaction 完整的临床试验报告 complete clinical trial report 特殊审批 special review and approval 有效成份 active ingredients 矿物 minerals 化学原料药 chemical drug substances 艾滋病 AIDS 恶性肿瘤 malignant tumors 罕见病 rare diseases 国家食品药品监督管理局药品审评中心 Center for Drug Evaluation of the State Food and Drug Administration 明显的临床应用优势 significant clinical advantage 靶向制剂 targeting delivery preparations 缓释 sustained release 控释制剂 controlled release preparations 注册分类 registration classification 药品注册申报资料 dossier for drug registration application 新药监测期 new drug observation period 临床前研究 pre-clinical study 药品注册申请表 Application Form for Drug Registration 药品注册申请受理通知书 acceptance notice of drug registration application 不予受理通知书 non-acceptance notice 原始资料 raw data 初步审查 preliminary review 生产批号 production batches 注册检验通知 notice for the testing for registration 审查意见 review opinions 核查报告 inspection reports 规定的时限 specified timeline 技术审评 technical review 补充资料 supplementary materials 技术审评意见 technical review opinions 药物临床试验批件 Drug Clinical Trial Approval 中国药品生物制品检定所 National Institute for the Control of Pharmaceutical and Biological Products. 研究资料 research information 药品标准 drug specifications 复核意见 verification opinions 不予批准的决定 disapproval decision 样品批量生产 large-scale samples production 生产现场检查报告 production site inspection report 生产车间 workshop 核定的药品标准 verified specifications 抄送 copy to 综合意见 general opinion 样品检验结果 sample testing results 新药证书 New Drug Certificate 药品生产许可证 Drug Manufacturing Certificate 特殊剂型 special dosage forms 公众健康 public health 监测期 observation period 疗效 therapeutic effect 严重质量问题 critical quality problem 申报与审批程序 review and approval procedures 境内药品生产企业 domestic manufacturers 同品种注册申请 registration applications for the same drug 仿制药申请人 applicant applying for registration of a generic drug 生产范围 production scope 中药品种保护 protection of traditional Chinese medicine preparations 行政决定 administrative decision 暂停 suspend 审批意见通知件 Disapproval Notice 样品检验 sample testing 临床试验资料 clinical trial data 上市许可 marketing authorization 药品注册检验报告 certificate of analysis for drug registration 进口药品标准 verified import specifications 中国香港、澳门和台湾地区 Hong Kong, Macao or Taiwan 证明文件 approved documents 直接接触药品的包装材料 immediate packaging materials 容器 containers 合法来源 lawful source 辅料 excipient 进口药品分包装 import drug repackaging 外包装 outer-package 标签 label 内包装 innerpackaging 片剂 tablets 胶囊 capsules 进口裸片 import unpackaged tablets 药品补充申请表 Drug Supplementary Application Form 报送的资料 submitted documents 药品补充申请批件 Approval for Supplementary Drug Application 进口分包装的药品 repackaged import drugs 进口药品注册标准 registration specifications for import drugs 药品生产企业的名称 name of drug manufacturer 境外大包装制剂 overseas pharmaceutical preparation in large package 非处方药 non-prescription drug 附加申请事项 additional application items 适应症 indications 功能主治 functions 新的复方制剂 new fixed dose combination 药品说明书 insert sheet 包装标签 package label 填写 fill in 有效期 shelf-life 生产场地 production site 产地 place of production 外观 appearance 药品生产技术转让 drug manufacturing technology transfer 药品注册批件 Letter of Approval for Drug Registration 有效期 valid term 系统评价 systematic assessment 产品质量的均一性 product quality consistency 药品再注册申请表 Application Form for Drug Re-registration 人体健康 human health 生产条件 production conditions 监测期责任 obligation of observation period 不予再注册的通知 notice of rejection for re-registration 品注册检验 testing for drug registration 药品标准复核 verification of specifications 实验室检验和审核 laboratory testing and review 放射性药品 radioactive pharmaceuticals 标准复核 specification verification 实验室质量管理规范 Good Laboratory Practice 国家计量认证 national metrology accreditation 质量保证体系 quality assurance system 委托 entrustment 国家药品标准 National drug standards 中华人民共和国药典 Pharmacopoeia of the Peoples Republic of China 药品注册标准 drug registration specifications, 特定药品 specified specifications 中国药典 Chinese Pharmacopoeia 药品标准物质 Drug reference standards 物理和化学测试及生物方法试验 physical, chemical or biological testing 校准设备 equipment calibration 评价测量方法 method validation 标准品 reference standards, 对照品 reference substances 对照药材 reference crude drugs 参考品 reference reagents 国家药品标准物质 national reference standards 药品研究机构 drug research institutions 全面技术审核 overall technical evaluation 原材料选择 source material selec