DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Latin Compendium NameCortex MoutanCrocus SativusCommon/ ChineseNameMu Dan PiSaffronRemarksE Equisetum arvense L. HorsetailF Flos Carthami Hong HuaFlos GenkwaFolium SennaeFructus AurantiiFructus Aurantii ImmaturusYuan HuaFan Xie YeZhi KeZhi ShiG Gentiana lutea GentianGinkgo BilobaGinkgoH Helleborus spp. HelleboreI Iris Versicolor Blue FlagIpecac IpecachuanaIpecacJ Juglans Canadensis ButternutJuglans nigraJuniper (Juniperuscommunis)Black WalnutJuniper BerriesL Leonurus Cardiaca MotherwortM Marrubium Vulgare HorehoundMentha PulegiumPennyroyalMonarda didymaBee BalmWhen used orallyor topicallyMylabris / Radix SacchariArundinaceiBan MaoN Natrii Sulfas Mang XiaoNepeta catariaCatnipO Oenothera biennis L. Evening PrimrosePPanax Ginseng, PanaxQuinquefoliusGinsengPassiflora incarnata L. Passion Flower When taken orallyNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 294
Drug Registration Guidance Document (<strong>DRGD</strong>)Latin Compendium NamePetroselinum CrispumPodophyllum PeltatumPolygala SenegaCommon/ ChineseNameParsleyAmerican MandrakeSenega SnakerootRemarksRRadix EuphorbiaePekinensisRadix et Rhizoma RheiRadix Kansui/ RadixEuphorbiae KansuiRadix PhytolaccaeRhizoma SparganiiResina Toxicodendri/Resina Rhois PraeparataRhizome et Radix VeratriRadix AchyranthisBidentataeRhizome ChuanxiongRhizome CurcumaeLongaeRhamnus PurshianaRhamnus FrangulaRheum PalmatumRuta GraveolensRheum AustraleJing Da JiDa HuangGan SuiShang LuSan LengGan QiLi LuNiu XiChuan XiongJiang HuangCascara SagradaBuckthornRhubarb RootRueTurkey RhubarbS Sanguinaria Canadensis BloodrootSemen PharbitidisSemen StrychniSemen PersicaeQian Niu ZiMa Qian ZiTao RenSerenoa repens Saw Palmetto When taken orallyT Tabebuia impetiginosa Pay D‟ Arco When taken orallyTanacetum partheniumFeverfewNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 295
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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