ALL 医学术语1.doc

Drugadverse reactions 不良反应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dosage form 剂型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Government AgenciesCoastal 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 andBiological 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 andBiological Products (NICPBP) 中国药品生物制品检定所(1) Laws / RegulationsChina 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 Transferof 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 Licenses / Certificates / Permitsa 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MLSSavailability 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 Enterprise 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u