药品常用英语缩写

1 61 GMP 英语词汇及缩写英语词汇及缩写 第一部分第一部分 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 计划 PIC S PIC 的权威翻译 药品生产检查相互承认公约 API Active Pharmaceutical Ingrediet 原料药 又称 活性药物组分 AirLock 气闸 Authorized Person 授权人 Batch Lot 批次 Batch Number Lot Number 批号 Batch Numbering System 批次编码系统 Batch Records 批记录 Bulk Product 待包装品 Calibration 校正 Clean area 洁净区 Consignmecnt Delivery 托销药品 FDA FOOD AND DRUG ADMINISTRATION 美国 食品药品管理局 IND INVESTIGATIONAL NEW DRUG 临床研究申请 指申报阶段 相对于 NDA 而 言 研究中的新药 指新药开发阶段 相对于新药而言 即临床前研究结束 NDA NEW DRUG APPLICATION 新药申请 ANDA ABBREVIATED NEW DRUG APPLICATION 简化新药申请 TREATMENT IND 研究中的新药用于治疗 ABBREVIATED NEW DRUG 简化申请的新药 DMF DRUG MASTER FILE 药物主文件 持有者为谨慎起见而准备的保密资料 可以包括一个或多个人用药物在制备 加工 包 装和贮存过程中所涉及的设备 生产过程或物品 只有在 DMF 持有者或授权代表以授权 书的形式授权给 FDA FDA 在审查 IND NDA ANDA 时才能参考其内容 HOLDER DMF 持有者 CFR CODE OF FEDERAL REGULATION 美国 联邦法规 PANEL 专家小组 BATCH PRODUCTION 批量生产 分批生产 BATCH PRODUCTION RECORDS 生产批号记录 POST OR PRE MARKET SURVEILLANCE 销售前或销售后监督 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接受治疗或试验 PRESCRIPTION DRUG 处方药 2 62 OTC DRUG OVER THE COUNTER DRUG 非处方药 第二部分第二部分 GMP 文件常见缩写文件常见缩写 ABPI Association of the British Pharmaceutical Industry ADR Adverse Drug Reaction AE Adverse Event AIM Active Ingredient Manufacturer ANDA Abbreviated New Drug Application 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 BNF British National Formulary BP British Pharmacopoeia C of A Certificate of Analysis C of S Certificate of Suitability CENTRE FOR DRUG EVALUATION CDE Centre for Pharmaceutical Administration CPA CMS Concerned Member State CMS 每个成员国 COS Certificate of Suitability 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 3 63 DGC Daily Global Comparison DIA Drug Information Association DMF Drug Master File Drug Registration Branch DR Product Evaluation Registration Division CPA EDQM European Directorate for the Quality of Medicines 欧洲联盟药品质量指导委员会 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 EP European Pharmacopoeia EPAR European Public Assessment Reports ESRA European Society of Regulatory Affairs European Pharmacopoeia Commission 欧洲药典委员会 FDA FDA Food and Drug Administration final evaluation report FER free sale certificates FSCs GCP Good Clinical Practice GCP 药品临床研究管理规范 GLP Good Laboratory Practice GLP 药品临床前安全性研究质量管理规范 GMP Good Manufacturing Practice GMP 药品生产质量管理规范 GSP 药品销售管理规范 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 IND Investigational New Drug INN International Non proprietary Name 4 64 International Conference on Harmonisation ICH IPC In Process Control IRB Institutional Review Board LICENCE HOLDER MA Marketing Authorisation MAA Marketing Authorisation Application MAA 上市申请 MAH Marketing Authorisation Holder MAH 销售许可持有者 MCA Medicines Control Agency 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 互相認證同意 MRFG Mutual Recognition Facilitation Group MRP Mutual Recognition Procedure NAS New Active Substance NCE New Chemical Entity NDA New Drug Application new chemical entities NCEs new drug applications NDAs NSAID Non Steroidal Anti Inflammatory Drug NTA Notice To Applicants OOS Out of Specification OTC Over The Counter PAGB Proprietary Association of Great Britain Ph Eur European Pharmacopoeia PIL Patient Information Leaflet PL Product Licence POM Prescription Only Medicine PRODUCT OWNER PSU Periodic Safety Updates QA Quality Assurance QC Quality Control RAJ Regulatory Affairs Journal 5 65 RMS Reference Member State RMS 相互认可另一成员国 RSD Relative Standard Deviation Rx Prescription Only SAE Serious Adverse Event SMF Site Master File SOP Standard Operating Procedure SOP STANDARD OPERATION PROCEDURE 标准运作程序 SPC SmPC Summary of Product Characteristics summary of product characteristics SPC Therapeutic Goods Administration TGA USP US Pharmacopoeia VMF Veterinary Master File VPC Veterinary Products Committee 第三部分第三部分 常用缩略语常用缩略语 A A A Addition and Amendments 增补和修订 AC Air Conditioner 空调器 ADR Adverse Drug Reaction 药物不良反应 AFDO Association of Food and Drug Officials 食品与药品官员协会 美国 ACC Accept 接受 AQL Acceptable Quality Level 合格质量标准 ADNA Abbreviated New Drug Application 简化的新药申请 BOM Bill of Material 物料清单 BPC Bulk pharmaceutical Chemiclls 原料药 CBER Center for Biologics Evaluation Research 生物制品评价与研究中心 CFU Colony Forming Unet 菌落形成单位 DMF Drug Master File 药品管理档案 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 在线清洗 CSI Consumer Safety Insepctor 消费者安全调查员 CLP Cleaning Line Procedure 在线清洗程序 DAL Defect Action Level 缺陷作用水平 6 66 DEA Drug Enforcement Adminestration 管制药品管理 DS Documentation Systim 文件系统 FDA Food and Drug Administration 食品与药品管理局 美国 GATT General Agreemernt on Tariffs and Trade 关贸总协会 GMP Good Manufacturing Practice Gvp 药品生质量管理规范 GCP Good Clinical Practice 药品临床实验管理规范 GLP Good Laboratory Practice 实验室管理规范 GSP Good Supply Practice 药品商业质量规范 GRP Gook RaTAIL Practice 药品零业质量管理规范 GAP Good Agriculture Practice 药材生产管理规范 GVP Gook V