86-10-65907696Glossary
(1) Laws / Regulations (2) Licenses / Certificates / Permits (3) Government Agencies (4) Drug (5) Medical Affair (6) Shipping / Importing (7) Reimbursement, hospital and EDL (8) Others
| (1) Laws / Regulations | |
| China Biological Products Standards | 中国生物制品规程 |
| Drug Administration Law of PRC | 中华人民共和国药品管理法 |
| international commonly-used pharmacopoeia | 国际通用药典 |
| National Drug Standard | 国家药品标准 |
| Patent Law of PRC | 中华人民共和国专利法 |
| Pharmacopoeia of PRC | 中华人民共和国药典 |
| Regulation for the Approval of New Drugs | 新药审批办法 |
| Regulation for the Protection and Technology Transfer of New Drugs |
新药保护和技术转让的规定 |
| Regulation for the Administration of Good Clinical Practice | 药品临床试验管理规范 |
| Regulation of TCM Protection | 中药品种保护条例 |
| State Standard | 国家标准 |
| Temporary Regulation on Drugs Covered by Basic Medical Insurance of Urban and Township Employees | 城镇职工基本医疗保险用药范围管理暂行办法 |
| 返回 | |
| (2) Licenses / Certificates / Permits | |
| a supplementary application | 补充申请 |
| classification protection system | 分类保护制度 |
| Drug Manufacturing License | 药品生产企业许可证 |
| Drug GMP Certificate | 药品GMP证书 |
| Drug Operation License | 药品经营企业许可证 |
| Declaration Form for Import Drug Inspection | 进口药品报验单 |
| Drug Product License | 医药产品注册证 |
| Import Drug License | 进口药品注册证 |
| letter of patent | 药品专利证明文件 |
| New Drug Certificate | 新药证书 |
| 返回 | |
| (3) Government Agencies | |
| Coastal Institutes for Drug Control | 口岸药品检验所 |
| Chinese Medicine Administration Bureau | 中医药局 |
| drug administration bureaus | 药品监督管理局 |
| Institute for the Control of Pharmaceuticals and Biological Products in each Province |
省级药品检验所 |
| Ministry of Labor and Social Security | 劳动保障部 |
| Ministry of Health | 卫生部 |
| Ministry of Finance | 财政部 |
| provincial drug supervision authorities | 省级药品监督管理部门 |
| State Administration of Industry and Commerce or its local bureaus | 中国工商行政管理部门 |
| State Development and Planning Commission | 国家计委 |
| State Economic and Trade Commission | 国家经贸委 |
| State Drug Administration | 国家药品监督局 |
| The National Institute for the Control of Pharmaceuticals and Biological Products ("NICPBP") |
中国药品生物制品检定所 |
| 返回 | |
| (4) Drug | |
| active ingredients | 原料 |
| acceleration stability study test data | 制品加速稳定性试验资料 |
| adverse reactions | 不良反应 |
| a trial period | 试产期 |
| biologics | 生物 |
| batch sample | 批样品 |
| bulk substance (including excipients) | 原材料(包括辅料) |
| bulk active | 原料药 |
| biological products for prevention [vaccines] | 预防性生物制品 |
| chemical drugs | 化学药品 |
| clinical demand | 临床需求 |
| clinical studies | 临床研究 |
| clinical effects | 临床疗效 |
| comparison products | 对照品 |
| drug formulation | 药品处方 |
| drug abstention | 戒毒药品 |
| drug formulation, production process, specification and quality-control method |
药品处方、生产工艺、质量标准及检验方法 |
| dosage form | 剂型 |
| expiration dating | 有效期 |
| excipient | 药用辅料 |
| except capsule | 空心胶囊除外 |
| finish dosage form of TCM | 中成药 |
| GMP requirements | 药品生产质量管理规范的要求 |
| generics | 仿制药品 |
| human bio-equivalence test | 人体生物等效性试验 |
| human bio-availability | 人体生物利用度 |
| insert sheet | 使用说明书 |
| ingredients | 成分 |
| INN name | 药品通用名称 |
| labeling and packaging materials | 标签及包装材料 |
| main ingredients | 主要成分 |
| narcotics | 麻醉药品 |
| prescription | 处方 |
| psychoactive products | 精神药品 |
| production process | 生产工艺 |
| pharmacological and toxicological studies | 药理、毒理 |
| presentation | 包装规格 |
| preparation form | 剂型 |
| provisional quality standard | 标准试行期 |
| radioactive drugs | 放射性药品 |
| stability studies | 稳定性研究 |
| specification | 质量标准 |
| strength | 规格 |
| shelf life | 药品有效期 |
| semi-finished preparations | 制剂半成品 |
| standard products | 标准品 |
| trial production, submission and sampling | 试制、申报资料、提供样品 |
| therapeutically | 临床 |
| trade name | 商品名 |
| the protection period | 保护期 |
| validity period | 有效期 |
| validity date | 有效期 |
| 返回 | |
| (5)Medical Affair | |
| Active-Control Studies | 阳性对照试验 |
| Adverse Drug Reaction (ADR) | 药品不良反应 |
| Adverse Event (AE) | 不良事件 |
| audit | 稽查 |
| batch / lot number | 批号 |
| blinding / masking | 设盲 |
| Bridging Data Package | 搭桥资料集/衔接性试验数据 |
| bridging study | 搭桥研究 / 衔接性试验 |
| broken procedures | 破盲规程 |
| Case Report Form (CRF) | 病例报告表 |
| causality assessment | 因果关系评价 |
| Clinical Data Package (CDP) | 临床资料集 |
| comparator products | 对照药 |
| compliance | 依从性 |
| Compounds Insensitive to Ethic Factors | 种族因素不敏感性药物 |
| Compounds Sensitive to Ethic Factors | 种族因素敏感性药物 |
| concomitant medication | 合并用药 |
| confirmatory trial | 验证性试验 |
| Contract Research Organization (CRO) | 合同研究组织 |
| coordinate committee | 协调委员会 |
| coordinate investigator | 协调研究者 |
| cross-over designs | 交叉设计 |
| direct access to source data | 直接查阅原始数据 |
| dose- response | 量效关系 |
| double blind trial | 双盲试验 |
| drop out | 出组 / 脱落 |
| dropouts or missing data | 脱落或缺失数据 |
| escape treatment | 出路治疗 |
| Ethics Committee | 伦理委员会 |
| expedited report | 快速报告 |
| exploratory trial | 探索性试验 |
| extrapolation of foreign clinical data | 国外临床资料的延用 |
| extrinsic ethic factors | 外在种族因素 |
| Final Report | 总结报告 |
| Good Clinical Practice (GCP) | 临床试验管理规范 |
| impartial witness | 公正见证人 |
| Independent Data Monitoring Committee (IDMC) | 独立数据监查委员会 |
| Independent Ethics Committee (IEC) | 独立伦理委员会 |
| Informed Consent Form | 知情同意书 |
| inspection | 视察 |
| Institutional Review Board (IRB) | 机构审查委员会 |
| interim clinical trial / study report | 临床试验/研究中期报告 |
| international birth day (IBD) | 国际首次上市日 |
| International Ethical Guidelines for Biomedical Research Involving Human Subjects |
人体生物医学研究国际道德指南 |
| International Non-Proprietary Name (INN) | 国际通用名 |
| intrinsic ethic factors | 内在种族因素 |
| investigational products | 临床试验用药品 |
| Investigator's Brochure (IB) | 研究者手册 |
| legally acceptable representative | 合法代表 |
| master randomization lists | 总随机表 |
| monitor | 监查员 |
| monitoring report | 监查报告 |
| original medical record | 原始医疗记录 |
| parallel group design | 平行组设计 |
| periodic safety update reports (PSURs) | 定期安全性更新报告 |
| pilot trial of limited size | 小样本预试验 |
| premature termination or suspension | 试验终止或暂停 |
| pretrial monitoring report | 试验前监查报告 |
| Primary Efficacy Variable(s) | 主要疗效变量 |
| protocol | 试验方案 |
| (protocol) amendment | （方案）修订/修改 |
| protocol deviations | 方案偏离 |
| Quality Control (QC) | 质量控制 |
| randomization | 随机化 |
| response variables | 效应变量 |
| retrospective data | 回顾性资料 |
| safeting report | 安全性报告 |
| safety and tolerability | 安全性和耐受性 |
| Serious Adverse Event | 严重不良事件 |
| source data / documents | 原始数据/文件 |
| sponsor | 申办者 |
| spontaneous report / notification | 自发性报告 / 通报 |
| Standard Operation Procedure (SOP) | 标准操作规程 |
| subinvestigator | 协作研究者 |
| subject compensation | 受试者赔偿 |
| subject exclusion criteria | 受试者排除标准 |
| subject identification code | 受试者识别代码 |
| subject inclusion criteria | 受试者入选标准 |
| subject screening log | 受试者筛选表 |
| subject withdrawal criteria | 受试者退出标准 |
| superiority trial | 优效性试验 |
| the personal integrity and welfare of the trial subjects | 受试者的个人权益 |
| therapeutic confirmatory | 治疗验证 |
| therapeutic exploratory | 治疗探索研究 |
| trial initiation monitoring report | 试验启动监查报告 |
| unblinding | 破盲 |
| unexpected adverse drug reaction | 非预期的药品不良反应 |
| vulnerable subjects | 易受影响的受试者 |
| withdraw patient | 剔除病例 |
| placebo concurrent control | 安慰剂平行对照 |
| active treatment concurrent control | 活性治疗平行对照 |
| does comparison concurrent control | 剂量比较平行对照 |
| historical concurrent control | 回顾性平行对照 |
| 返回 | |
| (6) Shipping / Importing | |
| Certificate of Origin | 产地证明 |
| duly unseal the goods, and permit allocation, marketing, and use |
及时启封，允许调拨、销售和使用 |
| designated port | 规定口岸 |
| packing list, invoice, bill of lading | 装箱单、运单、货运发票 |
| unqualified goods | 不合格药品 |
| 返回 | |
| (7) Reimbursement, hospital and EDL | |
| availability of drugs for basic medical care | 保障基本医疗用药 |
| A List | 甲类目录 |
| basic medical insurance | 基本医疗保险 |
| B List | 乙类目录 |
| Business License | 营业执照 |
| customary drugs | 用药习惯 |
| Community health stations | 社区卫生服务机构 |
| Drug List for Basic Medical Insurance | 基本医疗保险药品目录 |
| Designated Retail Drugstores | 定点零售药店 |
| Designated Medical Institution | 定点医疗机构 |
| Drug Operation License | 药品经营许可证 |
| economic disparity | 经济差异 |
| Hospitals of minority medicines | 民族医门诊部 |
| insured | 参保人员 |
| Labor Security Bureaus at various levels | 各级劳动保障行政部门 |
| Local labor and social security administrative departments | 地方劳动和社会保障部门 |
| Ministry of Labor and Social Security | 劳动保障部 |
| necessary for clinical use, safe, reasonably priced, convenient for use and have a sufficient supply in the market | 临床必需、安全有效、价格合理、使用方便、市场能够保证供应 |
| Operating License for Medical Institution | 医疗机构执业许可证 |
| percentage of self-payment | 个人自付的具体比例 |
| respective provinces, autonomous regions and directly governed cities | 省、自治区、直辖市 |
| standardize the administration of drugs covered by basic medical insurance | 规范基本医疗保险用药范围管理 |
| Social insurance agencies | 社会保险机构 |
| Specialize hospitals | 专科医院 |
| Temporary Regulation for the Administration of Designated Retail Drugstores for Urban Employees and Township Employees with Basic Medical Insurance. | 城镇职工基本医疗保险定点零售药店管理暂行办法 |
| The Temporary Regulation for the Administration of Designated Medical Institutes for Urban and Township Employees with Basic Medical Insurance | 城镇职工基本医疗保险定点医疗机构管理暂行办法 |
| The Certification for Drug-operation Enterprises | 药品经营企业许可证 |
| The overall local social insurance agency | 统筹地区劳动保障行政部门 |
| 返回 | |
| (8)Others | |
| documents shall be coded | 资料按编号 |
| duplicate copy | 副本 |
| epidemic | 疫情 |
| forged or a counterfeit | 伪造或假冒 |
| formulating | 规定 |
| filed with | 报___备案 |
| holder of original certificate | 证书拥有者 |
| invention | 创制 |
| innovation and technology upgrading | 创新和技术进步 |
| licensor | 转让单位 |
| notarization | 公正 |
| promulgate | 制定 |
| photocopy | 复印 |
| review fee | 审批费 |
| relevant | 有关 |
| route | 途径 |
| shall be effective from | 自___ 起执行 |
| standard format | 统一格式 |
| seal | 盖公章 |
| technical arbitration | 技术仲裁 |
| types of drugs | 药品的品种 |
| uniform number | 统一的批准文号 |
| untrue evidence or fake evidence | 弄虚作假，出具伪证 |
