DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 492
Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE2.4 Product NameItem No. 11:Issue: Addition of „or referring to the profession‟.Example: Addition of „Herbalist, Doctor‟.7.March2013Appendix 5,Guideline onRegistration ofNaturalProducts*For Ginseng:Appendix 4,Appendix 5 andAppendix 9Addition of new item which is numbered as No. 13:Issue:Prohibited use of product names referring to any religiouscontentExample: Maksum, Mahmudah, Arifbillah2.7 Labelling Requirementd) Example of label approved by the AuthorityReplacement with a new example.2.7.2 Specific Labelling Statements/ Warning & Precautionsa) Amendment from:For products containing GINSENG (including all Panaxgenus), please state:- “Safe use of ginseng in pregnant women and children hasnot been established.”- “Do not exceed the stated dose.”“Safety on long term use has not been established.”Memo from Sub-Section ofComplementary Medicine(24)dlm.BPFK/PPP/06/17Jilid 31, 29 March 2013To:National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 493
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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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