DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Botanical Name*Akebia trifoliata (Thunb.) Koidz.Asarum forbesii Maxim.Asarum heterotropoides F. SchmidtSyn. Asarum heterotropoides F. SchmidtSyn. Asiasarum heterotropoides (F. Schmidt) F.Maek.Asarum sieboldii Miq.Syn. Asarum sieboldii fo. seoulense (Nakai) C.Y.Cheng &C.S. YangSyn. Asarum sieboldii var. seoulensis NakaiSyn. Asiasarum heterotropoides var. seoulense(Nakai) F.Maek.Syn. Asiasarum sieboldii (Miq.) F. Maek.Clematis spp.Common or Other NamesMu tongThree leaf akebiaYu zhi ziBatei-saishin(Japanese)Keirin-saishin(Japanese)Chinese wild gingerManchurian wildgingerBei xi xinXin xinUsuba-saishin(Japanese)Chinese wild gingerXi XinHua Xi XinManchurian wildgingerSiebold's wild gingerClematisMufangjiClematidisIreisen (Japanese)Wojoksum (Korean)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 246
Drug Registration Guidance Document (<strong>DRGD</strong>)Clematis armandii Franch.Botanical Name*Syn. Clematis armandii fo. farquhariana (W.T.Wang)Rehder & E.H. WilsonSyn. Clematis armandii var. biondiana (Pavol.)RehderSyn. Clematis biondiana Pavol.Syn. Clematis ornithopus Ulbr.Clematis chinensis Osbeck.Common or Other NamesArmand's clematisChuan mu tong(stem)Xiao mu tongArmand's virginbowerChinese clematisWei ling xian (root)Clematis hexapetala Pall.Clematis montana Buch.-Ham. ex DC.Syn. Clematis insulari-alpina HayataClematis uncinata Champ. ex Benth.Syn. Clematis alsomitrifolia HayataSyn. Clematis chinensis var. uncinata (Champ. exBenth.) KuntzeSyn. Clematis drakeana H. Lév. & VaniotSyn. Clematis floribunda (Hayata) Yamam.Syn. Clematis gagnepainiana H. Lév. & VaniotSyn. Clematis leiocarpa Oliv.Syn. Clematis ovatifolia T. Ito ex Maxim.Syn. Clematis uncinata var. biternata W.T. WangSyn. Clematis uncinata var. coriacea Pamp.Syn. Clematis uncinata var. floribunda HayataSyn. Clematis uncinata var. ovatifolia (T. Ito exMaxim.)Ohwi ex TamuraSyn. Clematis uncinata var. taitongensis Y.C. Liu &C.H. OuNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 247
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Page 196 and 197: Appearance/organoleptic(odor, color
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Page 214 and 215: ATTACHMENT 1Drug Registration Guida
Page 222 and 223: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 224 and 225: ATTACHMENT 2Drug Registration Guida
Page 230 and 231: APPENDIX 5:Drug Registration Guidan
Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
Page 268 and 269: Route of AdministrationTAMC(CFU/g o
Page 276 and 277: d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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