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1、净化专业词汇中英文对照 Page 6 of 6GMP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 Ingredient) 原料药 又称：活性药物组分Air Lock 气闸 Authorized Person 授权人Batch/Lot 批次 Ba
2、tch 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；Consignment（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
3、）：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
4、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OTC DRUG（OVERTHECOUNTER DRUG）：非处方药GMP文件常见缩写ABPI Association of the British Pharmaceutical IndustryADR Adverse Drug R
5、eactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOVA Analysis of VarianceASM: Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBAN British Approved NameBIRA British Institute of Regulatory AffairsBNF B
6、ritish National FormularyBP British PharmacopoeiaC of A Certificate of Analysis C of S Certificate of SuitabilityCENTRE 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 Pr
7、oducts CRA Clinical Research Associate CRF Case Report Form CRO Contract Research Organization CTA Clinical Trial Application CTC Clinical Trial Certificate CTD Common Technical documentCTX Clinical Trials Exemption DDD Defined Daily Dose DGC Daily Global Comparison DIA Drug Information Association
8、DMF Drug Master File Drug Registration Branch (DR, Product Evaluation & Registration Division, CPAEDQM (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 License ApplicationEMEA European Medicines Evaluation AgencyEM
9、EA （European Agency for the Evaluation of Medicinal Products） 欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug AdministrationFinal Evaluation Report (FER)Free Sale Certif
10、icates (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)HSAs Medicines Advisory Committee (MAC)IB Investigators Brochure ICH International Conference for Harmonizatio
11、n IDMC Independent Data-Monitoring Committee IEC Independent Ethics Committee IND Investigational New Drug INN International Non-proprietary Name International Conference on Harmonization (ICH) IPC In Process Control IRB Institutional Review Board LICENCE HOLDERMA Marketing Authorization MAA Marketi
12、ng Authorization Application MAA上市申请MAH Marketing Authorization 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
13、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
14、Ph Eur European Pharmacopoeia PIL Patient Information Leaflet PL Product License POM Prescription Only Medicine PRODUCT OWNERPSU Periodic Safety Updates QA Quality Assurance QC Quality Control RAJ Regulatory Affairs Journal RMS Reference Member State RMS相互认可另一成员国RSD Relative Standard Deviation Rx Pr
15、escription Only SAE Serious Adverse Event SMF Site Master File SOP Standard Operating Procedure SOP （STANDARD OPERATION PROCEDURE） 标准运作程序SPC Summary of Product Characteristics Therapeutic Goods Administration (TGA)USP US Pharmacopoeia VMF Veterinary Master File VPC Veterinary Products CommitteeAAA 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AD
