PIC/S的全稱為：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制藥檢查草案), 藥品檢查協(xié)會(huì)(PIC/S) ,也有人稱PIC/S為醫(yī)藥審查會(huì)議/合作計(jì)劃（PIC/S)
PIC的權(quán)威翻譯：藥品生產(chǎn)檢查相互承認(rèn)公約
API(Active Pharmaceutical Ingredient) 原料藥 又稱：活性藥物組分
Air Lock 氣閘 Authorized Person 授權(quán)人 Batch/Lot 批次
Batch Number/Lot-Number 批號(hào)；Batch Numbering System 批次編碼系統(tǒng)；
Batch Records 批記錄；Bulk Product 待包裝品；Calibration 校正；Clean area潔凈區(qū)；Consignment（Delivery)托銷藥品。
FDA（FOOD AND DRUG ADMINISTRATION)：（美國)食品藥品管理局
IND（INVESTIGATIONAL NEW DRUG)：臨床研究申請(qǐng)（指申報(bào)階段,相對(duì)于NDA而言)；研究中的新藥（指新藥開發(fā)階段，相對(duì)于新藥而言，即臨床前研究結(jié)束)
NDA（NEW DRUG APPLICATION)：新藥申請(qǐng)
ANDA（ABBREVIATED NEW DRUG APPLICATION)：簡化新藥申請(qǐng)
TREATMENT IND：研究中的新藥用于治療
ABBREVIATED（NEW)DRUG：簡化申請(qǐng)的新藥
DMF（DRUG MASTER FILE)：藥物主文件（持有者為謹(jǐn)慎起見而準(zhǔn)備的保密資料，可以
包括一個(gè)或多個(gè)人用藥物在制備、加工、包裝和貯存過程中所涉及的設(shè)備、生產(chǎn)過程或物
品。只有在DMF持有者或授權(quán)代表以授權(quán)書的形式授權(quán)給FDA，F(xiàn)DA在審查IND、
NDA、ANDA時(shí)才能參考其內(nèi)容)
HOLDER：DMF持有者
CFR（CODE OF FEDERAL REGULATION)：（美國)聯(lián)邦法規(guī)
PANEL：專家小組
BATCH PRODUCTION：批量生產(chǎn)；分批生產(chǎn)
BATCH PRODUCTION RECORDS：生產(chǎn)批號(hào)記錄
POST-OR PRE- MARKET SURVEILLANCE：銷售前或銷售后監(jiān)督
INFORMED CONSENT：知情同意（患者對(duì)治療或受試者對(duì)醫(yī)療試驗(yàn)了解后表示同意接受治療或試驗(yàn))
PRESCRIPTION DRUG：處方藥
OTC DRUG（OVER—THE—COUNTER DRUG)：非處方藥
GMP文件常見縮寫
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每個(gè)成員國
COS Certificate of Suitability
CPMP Committee for Proprietary Medicinal Products
CRA Clinical Research Associate
CRF Case Report Form
CRO Contract Research Organization
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) 歐洲聯(lián)盟藥品質(zhì)量指導(dǎo)委員會(huì)
EEA 歐洲經(jīng)濟(jì)地區(qū)
EGMA European Generics Medicine Association
ELA Established License Application
EMEA European Medicines Evaluation Agency
EMEA （European Agency for the Evaluation of Medicinal Products) 歐洲聯(lián)盟藥品評(píng)價(jià)機(jī)構(gòu)
EP European Pharmacopoeia
EPAR European Public Assessment Reports
ESRA European Society of Regulatory Affairs
European Pharmacopoeia Commission 歐洲藥典委員會(huì)
FDA
FDA Food and Drug Administration
Final Evaluation Report (FER)
Free Sale Certificates (FSCs)
GCP Good Clinical Practice
GCP藥品臨床研究管理規(guī)范 醫(yī)學(xué)全在線www.med126.com
GLP Good Laboratory Practice
GLP 藥品臨床前安全性研究質(zhì)量管理規(guī)范
GMP Good Manufacturing Practice
GMP 藥品生產(chǎn)質(zhì)量管理規(guī)范
GSP藥品銷售管理規(guī)范
Health Sciences Authority (HSA)
HSA’s Medicines Advisory Committee (MAC)
IB Investigators Brochure
ICH International Conference for Harmonization
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 HOLDER
MA Marketing Authorization
MAA Marketing Authorization Application
