DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)FDAFDIFEOFPQCFSQDFTIRgGCGCPGDPGMPHACCPHBsAgHBVHCVHDPEHIVHPLCHSICHINNFood and Drug AdministrationFood-Drug InterfaceFor Export OnlyFinished Product SpecificationFood Safety and Quality DivisionFourier Transform InfraredgramGas ChromatographyGood Clinical PracticeGood Distribution PracticeGood Manufacturing PracticeHazard analysis and critical control pointsSurface Antigen of the Hepatitis B VirusHepatitis B VirusHepatitis C VirusHigh-density polyethyleneHuman immunodeficiency virusHigh Performance Liquid ChromatographyHealth SupplementInternational Conference on Harmonisation of Technical Requirements forRegistration of Pharmaceuticals for Human UseInternational Non-proprietary NamesNational Pharmaceutical Control BureauFirst Edition, January 20138
Drug Registration Guidance Document (<strong>DRGD</strong>)IPQCISOJAKIMJPLLALLOALOCLOImAbmaxMCBMDDCImLMPNMSMMVDNATNCENDPIn-Process Quality ControlInternational Organization for StandardizationMalaysia Department of Islamic Development(Jabatan Kemajuan Islam Malaysia)Japanese PharmacopoeiaLitreLimulus Amebocyte LysateLetter of AuthorizationLetter of CommitmentLetter of Intentmonoclonal antibodymaximumMaster Cell bankMedical Device-Drug-Cosmetic InterfacemillilitreMost-Probable NumberMethylsulphonylmethaneMaximum Valid DilutionNucleic Acid TestingNew Chemical EntityNew Drug ProductNational Pharmaceutical Control BureauFirst Edition, January 20139
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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