1、药品管理法 -常用词汇列表药品生产企业 drug manufactory药品经营企业 drug distribution医疗机构 medical institution药品包装 drug packaging野生药材 natural crude drugs中药材 Chinese crude drugs药品检验机构 drug testing institution(s)药品生产许可证 Drug manufacturing certificate药品经营许可证 Drug supply certificate医疗机构制剂许可证 Pharmaceutical preparation certificat
2、e for medical institution药品生产质量管理规范 Good manufacturing practice for pharmaceutical products (GMP)国家药品标准 National drug standard药品批发企业 drug wholesaler通用名称 generic name商品名 trade name剂型 dosage form规格 specification批号 batch number;lot number处方 prescription产地 origin冷藏 cold storage冷冻 refrigeration检验仪器 testi
3、ng instruments制剂 (pharmaceutical) preparations标识 marks临床试验 clinical trails中华人民共和国药典 Pharmacopoeia of the PRC药品标准 drug standards药典委员会 pharmacopoeia committee 麻醉药品 narcotic drugs精神药品 psychotropic drugs医疗用毒性药品 medicinal toxic drugs放射性药品 radioactive drugs不良反应 adverse reaction进口药品通关单 Drug Import Note药品管理
4、法实施条例-常用词列表验收 acceptance inspection注射剂 injections放射性药品 radioactive pharmaceuticals生产剂型 dosage forms for production药品生产质量管理规范认证GMP certification / GMP inspection 药品生产质量管理规范认证检查员GMP inspector甲类非处方药 Class A non-prescription drugs乙类非处方药 Class B non-prescription drugs执业药师 licensed pharmacist执业医师 licensed
5、 doctors执业助理医师 licensed assistant doctors药学技术人员 pharmaceutical technicians药品经营许可证许可事项 approved items in the Drug Supply Certificate互联网药品交易服务的管理办法The measures for administration of on-line drug distribution services制剂室 pharmaceutical preparation unit卫生行政部门 Health administrative department医疗机构制剂许可证 Ph
6、armaceutical preparation certificate for medical institution医疗机构执业许可证 Practicing license of medical institution药品购进记录 purchase records购货数量 purchase volume购货日期 date of purchase诊疗范围 scope of diagnoses and treatments药物非临床安全性评价研究机构Institutions for non-clinical safety evaluation and study of drugs药物临床试验机
7、构 institutions for drug clinical trail试制的样品 pilot samples证明文件 supporting documents试行期标准 interim standard出厂检验报告书 certificate of analysis for the release of drugs by the manufactory用于血源筛查的体外诊断试剂 diagnostic reagents in vitro for blood donor screening直接接触药品的包材和容器 Immediate packaging materials and contai
8、ners药品性质 drug properties政府价格主管部门 the competent pricing department of the government中华人民共和国价格法 the pricing low of the PRC价格监测定点单位 drug price monitoring units药品广告批准文号 approval number for drug advertisement检验方法 testing method 检验项目 testing items 药品质量公告 drug quality announcement 检验依据 drug specifications（
9、？）复验 re-testing留样 retaining sample药品检验费用 fees for drug testing药品认证 drug certification 强制性检验 mandatory drug testing 药品注册管理办法-常用词汇列表管理办法 Provisions/regulations中华人民共和国行政许可法 Administrative permission law of the PRC药品进口 drug import审批过程 the process of review and approval创新药 innovative drugs责任追究制 the syste
10、m of responsibility tracing受理 acceptance检验 inspection 审评 review 审批 approval举行听证 hold hearings(on) 行政许可 administrative license利害关系人 the interest party注册申请受理场所 official premise for accepting applications药品注册申请人 applicant for drug registration药品注册申请 drug registration application境外合法制药厂商 legal overseas
11、drug manufacturer进口药品注册 import drug registration仿制药 generic drug进口药品 import drug补充申请 supplementary application再注册申请 re-registration application给药途径 route of administration现场核查 on-site inspection有因核查 causal inspection生产现场检查 production site inspection 进口药品注册证 Import Drug License 医药产品注册证 Pharmaceutical
12、 Product License药物临床前研究 pre-clinical study药物的合成工艺 drug synthetic processes 提取方法 extraction method理化性质 physical and chemical properties 纯度 purity 剂型选择 selection of dosage form 制备工艺 preparing processes检验方法 testing methods质量指标 quality specification稳定性 Stability药理 pharmacology 毒理 toxicology动物药代动力学研究 ani
13、mal pharmacokinetics原药材 the crude drugs 生物制品 biological product生物学特性 biological characteristics遗传稳定性 genetic stability免疫学研究 immunological study菌毒种 bacterial and viral seeds/strains细胞株 cell lines生物组织 bio-tissues 安全性评价研究 the study of safety evaluation 方法学验证 methodological verification生物等效性试验 bioequiva
14、lence study 药物临床试验质量管理规范 Good Clinical Practice治疗作用 therapeutic effectiveness随机盲法对照临床试验 the randomized blind controlled clinical trail药代动力学参数 pharmacokinetic parameter罕见病、特殊病种 rare or special disease 伦理委员会 ethic committee 统计分析报告 statistical analysis report靶向制剂 target delivery preparation缓释制剂 sustain
15、ed release preparation 控释制剂 controlled release preparation 形式审查 preliminary review 受理通知书 acceptance notice 不予受理通知书 non-acceptance notice 注册检验通知 notice for the testing for registration药品注册检验报告 certificate of analysis for drug registration药物临床试验批件 Drug Clinical Trail Approval 审批意见通知件 Disapproval Notic
16、e药品注册申请表 Application form for drug registration生产现场检查通知 notice of production site inspection 核定的药品标准 verified specifications新药监测期 new drug observation period设立监测期 set an observation period上市许可 drug marketing authorization注册检验 testing for registration进口药品分包装 import drug repackaging内包装 inner-package 外
17、包装 outer-package说明书 insert sheets药品补充申请批件 Approval for supplementary drug application 药品补充申请表 Supplementary drug application form药品注册批件 Letter of Approval for Drug Registration药品再注册申请表 Application form for drug re-registration 复方制剂 compound preparation 包装标签 package label补充申请 supplementary applicatio
18、n 核定的生产工艺 verified manufacturing process药品再注册申请受理通知书 Acceptance notice of drug re-registration application不予再注册的通知 Notice of rejection for re-registration 药品检验所 drug testing institute国家计量认证 National metrology accreditation复核意见 verification opinions 药品注册标准 drug registration specifications国家药品标准编写原则 rules for compiling the national drug standards 定值准确性 accuracy of value assignment分装与包装条件 filling and packaging conditions 药品注册时限 timeline for drug registration 核查报告 inspection report补充资料通知 Deficiency Notice药品注册复审申请表 second review 监察机关 supervisory departments
