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ANDA簡(jiǎn)化新藥申請(qǐng)abbreviated new drug applications         

API原料藥active pharmaceutical ingredient

AQSIQ國家質(zhì)檢總局Administration of Quality Supervision, Inspection and Quarantine

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

CDER藥品審評(píng)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(dāng)前GMP、國際GMP規(guī)范  (c=current)     

CMC  化學(xué)、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(shù)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(cè)識(shí)別號(hào)Facility Establishment Identifier 

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

GMP   Good Manufacturing Practice

GPhA美國仿制藥協(xié)會(huì)@華盛頓

HHS健康和公眾服務(wù)部Health and Human Services

IID非活性成分?jǐn)?shù)據(jù)庫inactive ingredient database

ICH國際協(xié)調(diào)會(huì)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(shù)產(chǎn)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(wù)辦公室Office of Chief Counsel

OGD仿制藥辦公室Office of Generic Drug

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

OIP國際項(xiàng)目辦公室Office of International Programs

OND  新藥辦公室Office of New Drug

ONDQA新藥質(zhì)量評(píng)估辦公室Office of New Drug Quality Assessment 

OPQ  藥品質(zhì)量辦公室Office of Pharmaceutical Quality

ORA監(jiān)管事務(wù)辦公室

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

OSP戰(zhàn)略項(xiàng)目辦公室

OTS轉(zhuǎn)化科學(xué)辦公室

PAG項(xiàng)目并進(jìn)小組Program Alignment