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ANDA簡化新藥申請abbreviated new drug applications         

API原料藥active pharmaceutical ingredient

AQSIQ國家質檢總局Administration of Quality Supervision, Inspection and Quarantine

CBER生物制品評審與研究中心Center for Biologics Evaluation and Research 

CDER藥品審評與研究中心Center for Drug Evaluation and Research 　　 CDER's MAPP 5240.3

CDRH器械和輻射健康中心Center for Devices and Radiological Health 

CFDA中國國家食品藥品監(jiān)督管理局

cGMP當前GMP、國際GMP規(guī)范  (c=current)     

CMC  化學、制造、控制

DMF藥物主文件drug master file

DUNS  Data Universal Numbering System 

eCTD電子版通用技術文件Electronic Common Technical Document 

FDASIA   Food and Drug Administration Safety and Innovation Act 

FDF成品藥、藥品劑型完成 finished dosage form

FEI工廠注冊識別號Facility Establishment Identifier 

GDUFA仿制藥企業(yè)付費法/仿制藥用戶收費法案Generic Drug User Fee Amendment/Act

GMP   Good Manufacturing Practice

GPhA美國仿制藥協(xié)會@華盛頓

HHS健康和公眾服務部Health and Human Services

IID非活性成分數據庫inactive ingredient database

ICH國際協(xié)調會議International Conference on Harmonisation

IR信息要求information request

NIH美國國立衛(wèi)生研究院

OBP生物技術產品辦公室

OC合規(guī)辦公室Office of Compliance  //局長辦公室/專員Commissioner辦公室

OCC法律事務辦公室Office of Chief Counsel

OGD仿制藥辦公室Office of Generic Drug

OGROP全球業(yè)務和政策監(jiān)管辦公室Office of Global Regulatory Operations & Policy

OIP國際項目辦公室Office of International Programs

OND  新藥辦公室Office of New Drug

ONDQA新藥質量評估辦公室Office of New Drug Quality Assessment 

OPQ  藥品質量辦公室Office of Pharmaceutical Quality

ORA監(jiān)管事務辦公室

OSE監(jiān)管和流行病辦公室Office of Surveillance and Epidemiology

OSP戰(zhàn)略項目辦公室

OTS轉化科學辦公室

PAG項目并進小組Program Alignment