FDA和EDQM术语.docx

本文格式为Word版，下载可任意编辑FDA和EDQM术语 FDA和EDQM术语: ACCELERATED APPROVAL：加速批准 INVESTIGATOR：研究人员；调研人员 PREPARING AND SUBMITTING：起草和申报 RISK（S）：受害 DRUG SUBSTANCE：原料药 GENERIC NAME：非专利名称 PROPRIETARY NAME：专著名称； INN（INTERNATIONAL NONPROPRIETARY NAME）：国际非专著名称 ARCHIVAL COPY：存档用副本 REVIEW COPY：审查用副本 OFFICIAL COMPENDIUM：法定药典（主要指USP、 NF）．OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的 AGENCY：审理部门（指FDA） STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量） REGULATORY SPECIFICATION：质量管理规格标准（NDA供给） REGULATORY METHODOLOGY：质量管理方法 REGULATORY METHODS VALIDATION：管理用分析方法的验证 ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议 ICH文件分为质量、安好性、有效性和综合学科4类。

质量技术要求文件以Q开头,再以a,b,c,d代表小项: Q1:药品的稳定性 Q2:方法学 Q3:杂质 Q4:药典 Q5:生物技术产品质量 Q6:标准规格 Q7:GMP Q7a:（原料药的优良制造模范指南）药物活性成分的GMP. GMP英语 PIC/S的全称为：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作筹划（PIC/S） PIC的权威翻译：药品生产检查相互供认公约 PANEL：专家小组 Air Lock 气闸 Authorized Person 授权人 Batch Numbering System 批次编码系统； Consignmecnt（Delivery）托销药品 TREATMENT IND：研究中的新药用于治疗 ABBREVIATED（NEW）DRUG：简化申请的新药 CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规 POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监视 INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意采纳治疗或试验） GMP文件常见缩写 ABPI Association of the British Pharmaceutical Industry AE Adverse Event AIM Active Ingredient Manufacturer ANOVA Analysis of Variance ASM: Active Substance Manufacturer ATC Anatomical Therapeutic Chemical ATX Animal Test Exemption Certificate BAN British Approved Name BIRA British Institute of Regulatory Affairs CENTRE FOR DRUG EVALUATION (CDE) Centre for Pharmaceutical Administration (CPA) CMS Concerned Member State CPMP Committee for Proprietary Medicinal Products CRA Clinical Research Associate CRF Case Report Form CRO Contract Research Organisation CTA Clinical Trial Application CTC Clinical Trial Certificate CTD Common Technical Document CTX Clinical Trials Exemption DDD Defined Daily Dose DGC Daily Global Comparison DIA Drug Information Association Drug Registration Branch (DR, Product Evaluation & Registration Division, CPA EEA 欧洲经济地区 EGMA European Generics Medicine Association ELA Established Licence Application EMEA European Medicines Evaluation Agency EMEA （European Agency for the Evaluation of Medicinal Products） 欧洲联盟药品评价机构 EPAR European Public Assessment Reports ESRA European Society of Regulatory Affairs FDA final evaluation report (FER) free sale certificates (FSCs) Health Sciences Authority (HSA) HSA’s Medicines Advisory Committee (MAC) IB Investigators Brochure ICH International Conference for Harmonisation IDMC Independent Data-Monitoring Committee IEC Independent Ethics Committee International Conference on Harmonisation (ICH) IPC In Process Control IRB Institutional Review Board MA Marketing Authorisation MAA Marketing Authorisation Application 上市申请 MCA Medicines Control Agency MAH Marketing Authorisation Holder MAH 销售许可持有者 MHW Ministry of Health and Welfare (Japan) MR Mutual Recognition MRA 美国与欧盟的互认协议 MRAs (Mutual Recognition Agreements) 彼此認證同意 MRFG Mutual Recognition Facilitation Group MRP Mutual Recognition Procedure NAS New Active Substance NCE New Chemical Entity new chemical entities (NCEs) NSAID Non Steroidal Anti Inflammatory Drug NTA Notice To Applicants OOS Out of Specification PAGB Proprietary Association of Great Britain PIL Patient Information Leaflet POM Prescription Only Medicine PRODUCT OWNER PSU Periodic Safety Updates RAJ Regulatory Affairs Journal RMS Reference Member State RMS相互认可另一成员国 Rx Prescription Only SAE Serious Adverse Event SMF Site Master File SPC/SmPC Summary of Product Characteristics summary of product characteristics(SPC) Therapeutic Goods Administration (TGA) VMF Veterinary Master File VPC Veterinary Products Committee A．A．A Addition and Amendments 增补和修订 ACC Accept 采纳 AFDO Association of Food and Drug Officials 食品与药品官员协会（美国） AQL Acceptable Quality Level 合格质量标准 BOM Bill of Material 物料清单 CBER Center for Biologics Evaluation Research CFU Colony Forming Unet 菌落形成单位 CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心 CI Corporate Identity (Image) 企业识别（形象） CIP Cleaning in Place 清洗 CSI Consumer Safety Insepctor 消费者安好调查员 CLP Cleaning Line Procedure 清洗程序 DAL Defect Action Level 缺陷作用水平 DEA Drug Enforcement Adminestration 管制药品管理 DS Documentation Systim 文件系统 GATT General Agreemernt on Tariffs and。