DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEMaterial (Label, Box, Package Insert or Patient InformationLeaflet)”b) Addition of the following paragraph under this title 2.7.4:"General requirement: The graphics printed on outer andinner label has to be standardized to avoid confusion to thecustomers."1. April 2013Section E:Post-RegistrationProcessReplacement with the latest information at 16.3 Change ofProduct Registration HolderDrug Control AuthorityMeeting No. 263, 29 April20131. May 2013Section A:GeneralOverview; 6.GeneralConditions forRegistration ofDrug Productsunder theControl ofDrugs andCosmeticsRegulations1984Addition of link to specific circulars/ directives pertainingsecurity label (hologram) as per listed below at 6.4 ProductAuthentication:a) “Circulars and directives pertaining to security label(hologram):i) Bil (32) dlm BPFK/02/5/1.3ii) Bil (36) dlm BPFK/02/5/1.3iii) Bil (62) dlm BPFK/02/5/1.3iv) (88)dlm.BPFK/PPP/01/03 Jilid 2v) (1)dlm.BPFK/PPP/07/25 Jld. 1”Circulars and directive aslinked; latest directive(1)dlm.BPFK/PPP/07/25, 4April 2013: Pelaksanaandan Pengendalian LabelKeselamatanNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 492
Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE2. May 2013Section B:ProductRegistrationProcessAddition of the following paragraph at 8.1.6 Second orThird Source:“A second source product, excluding biologic products, maydiffer for the following aspects:a) equipments/ machines;b) minor manufacturing process (e.g. blending time, number ofsub-parts);c) batch size;d) packaging materials, thickness of same packagingmaterials, pack sizes;(Note: Use of different packaging material shall be supportedwith stability study report.)e) manufacturer of API; andf) source of excipients.EXCEPT differences in shape, embossment and thickness oftablet, in order to avoid change in product identity andsubsequently causing confusion.Pharmacy RegulatoryPolicy MeetingNo. 1/2013The manufacturer shall declare with support of manufacturingvalidation process data that there is no change in formulation,specification of active ingredient(s) and excipient(s), andfinished product for the second source product compared to thefirst source.For pharmaceutical product, no third source is allowed for sameproduct unless in emergency situation such as outbreak ofinfectious disease.”National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 493
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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