DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEAddition of the paragraph and link:12.1 FOREIGN GMP INSPECTIONPRH must provide acceptable evidence to show that themanufacturer of the product follows an internationally acceptedstandard of Good Manufacturing Practice (GMP) and recognizedby the Authority in Malaysia.4.March2013Section D:Inspection &LicensingThe Control of Drugs and Cosmetics Regulations 1984 (CDCR)requires that the standard of manufacture and quality control ofmedicinal products manufactured outside Malaysia is taken intoconsideration before the products are registered with theAuthority. NPCB as the secretariat to the DCA is responsible toensure all manufacturers of registered products in Malaysia areable to provide acceptable evidence that the manufacturingpremises conform to current GMP requirements. Hence, foreignmanufacturers are also subjected to GMP conformityassessments through acceptable GMP evidence or GMPinspection.Premises InspectionEvaluation Committee No.3/2013, 14 March 2013For details and forms, please refer Guidance Document onForeign GMP Inspection.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 482
Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE5.March2013Section E: PostRegistrationProcessDeletion of „EMEA‟ and addition of „Switzerland‟ in thefollowing paragraph, as highlighted in yellow:16.4.2 VERIFICATION PROCESSFor new indication which has been registered in EuropeanCountries/ EMEA (United Kingdom, Sweden and/or France) andone of the other Authority‟s reference countries (United States ofAmerica, Australia, Canada, and Japan and Switzerland).Memo from Section ofNew Medicine(2)dlm.BPFK/PPP/06/17Jilid 31, 13 March 2013Addition of the following paragraph:6.March2013Appendix 2:Requirementsfor ProductRegistrationEffective 1 st March 2013, biowaiver may be granted to genericimmediate release oral solid dosage form products containingBCS Class I active ingredients listed in the Guidance OnBiopharmaceuticals Classification System (BCS) – BasedBiowaiver document. BCS Based biowaivers takes the threemajor factors that govern the rate and extent of drug absorptionfrom immediate-release solid dosage forms into accounts i.e.solubility and permeability of the drug substance/ API, anddissolution characteristics of the dosage form. This BCSapproach provides an opportunity to waive in vivopharmacokinetic bioequivalence testing for certain categories ofimmediate-release drug products.(Directive Arahan di Bawah Peraturan 29, Peraturan-peraturanKawalan Dadah dan Kosmetik 1984 Bil. 1 Tahun 2013, 14October 2011, 28 February 2013, Bil (101)dlm.BPFK/PPP/01/03Jld 2).Memo from Sub-Section ofGeneric Medicine(7)dlm.BPFK/PPP/06/17Jilid 31, 21 March 2013National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 483
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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