医药行业专业英语词汇

医药行业专业英语词汇（非常有用）

FDA和EDQM术语: CLINICAL?TRIAL：临床试验? ANIMAL?TRIAL：动物试验? ACCELERATED?APPROVAL：加速批准? STANDARD?DRUG：标准药物? INVESTIGATOR：研究人员；调研人员PREPARING?AND?SUBMITTING：起草和申报? SUBMISSION：申报；递交? BENIFIT （S）：受益? RISK（S）：受害? DRUG?PRODUCT：药物产品? DRUG?SUBSTANCE：原料药? ESTABLISHED?NAME：确定的名称? GENERIC?NAME：非专利名称? PROPRIETARY?NAME：专有名称；? INN（INTERNATIONAL?NONPROPRIETARY?NAME）：国际非专有名称? ADVERSE?EFFECT：副作用? ADVERSE?REACTION：不良反应? PROTOCOL：方案? 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）．? USP （THE?UNITED?STATES?PHARMACOPEIA）：美国药典NF（NATIONAL?FORMULARY）：（美国）国家处方集? OFFICIAL＝PHARMACOPEIAL=?COMPENDIAL：药典的；法定的；官方的? AGENCY：审理部门（指FDA）? IDENTITY：真伪；鉴别；特性? STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量）? LABELED?AMOUNT：标示量? REGULATORY?SPECIFICATION：质量管理规格标准（NDA提供）? REGULATORY?METHODOLOGY：质量管理方法? REGULATORY?METHODS?VALIDATION：管理用分析方法的验证COS/CEP?欧洲药典符合性认证ICH

（International?Conference?on?Harmonization?of?Technical?Requirements?for?Registration?of PharmaceuticalsforHumanUse)人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、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:（原料药的优良制造规范指南）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? OTC?DRUG（OVER—THE—COUNTER?DRUG）：非处方药? GMP 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? 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? 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)?互相认证同意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? 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?