DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NoDocument To Be SubmittedTypeITypeIITypeIIITypeIVTypeV13. Comparative dissolution profile between theproposed and current site for oral solid dosageforms that are entitled for “biowaiver”.For further information, please refer circular:Bil (31) dlm. BPFK/PPP/01/03ORReport of bioavailability and bioequivalencestudies for generic products.√√ORComparative dissolution profile between theproposed and current site for oral solid dosageforms for innovator products, if applicable.(Please refer to ASEAN Guidelines and list ofproducts requiring BA and BE study).14. Letter of commitment to submit comparativedissolution profile between the proposed andcurrent site for oral solid dosage forms that areentitled for “biowaiver”.For further information, please refer circular:Bil (31) dlm. BPFK/PPP/01/03ORLetter of commitment to submit report ofbioavailability and bioequivalence studies forgeneric products.√√ORLetter of commitment to submit comparativedissolution profile between the proposed andcurrent site for oral solid dosage forms forinnovator products, if applicable.(Please Refer to ASEAN Guidelines and list ofproducts requiring BA and BE study).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 482
Drug Registration Guidance Document (DRGD)LIST OF UPDATESUPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE1.January2013Section A, 7.Use of HalalLogoAddition of the following:a) Reference: Circular (95)dlm.BPFK/PPP/01/03 Jld. 2 at a)Generics (non-scheduled poison), excluding parenteraldosage form and veterinary products.b) As last paragraph:Applicant shall submit application for variation type II toNPCB for approval to affix halal logo on product label of aregistered product of which a halal certification has beengranted. A copy of the halal certificate must be submittedas a supporting document.Circular(95)dlm.BPFK/PPP/01/03Jld. 2, 26 December 2012:Penggunaan Logo HalalBagi ProdukFarmaseutikal berdaftarkategori produk bukanracun, OTC2.January2013Section A,1.3.2Classification ofFDI ProductsAddition of the following:Notes:Applicant shall verify on FDI product classification with NPCB inorder to determine whether the product shall be registered bythe Authority or otherwise.Reference: Circular (97)dlm.BPFK/PPP/01/03 Jld. 2Circular(97)dlm.BPFK/PPP/01/03Jld. 2, 27 December 2012:Pengkelasan ProdukFood-Drug InterfaceNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 483
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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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