DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED6. Replacement of anexcipient with acomparable excipientand/or change in contentof excipient.A2.1B1.2P1P4.1P4.2P3.2P3.2.1E11P5.4P8E12D1D2D3(if applicable)A4.2B1.2B2.1B2.2B3B4B5F10F12D1D2D3(if applicable)CONDITIONS1. Finished product release and end of shelf lifespecification remains the same.2. There is no change in dissolution profile for oralsolid dosage forms (where applicable).3. Replacement of an excipient with a comparableexcipient of the same functional characteristics.4. No changes on the specification of the excipientfor product specific requirements (e.g. particle sizeprofiles, polymorphic form, etc.), if applicable.5. Any new excipient does not include the use ofmaterials of human or animal origin for whichassessment is required of viral safety data.SUPPORTING DOCUMENTS1. Comparison of new and existing formula.2. Batch Manufacturing Formula.3. Excipient specification (if applicable).4. Manufacturing process with amendments.5. Certificate of Analysis (CoA) of drug product.6. Justification for not submitting a newbioequivalence study according to ASEANGuidelines for the Conduct of Bioavailability andBioequivalence Studies (where applicable).7. Comparative dissolution profile data of at leastone representative pilot/production batch of thedrug product between the currently approved andNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 466
Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIEDproposed solid dosage forms formulation (whereapplicable).8. Stability data of drug product (please refer toASEAN Guideline On Stability Study of DrugProduct)9. Revised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).10. Batch analysis data.11. Product interchangeability/ equivalent evidence (ifany).12. Justification for the change supported byappropriate development of pharmaceutics.13. New unit formula for coating agent (whereapplicable).7. Change in batch size B1.2E11P5.4P3.4E12P3.2P3.2.1(if applicable)B1.2F10F12B2.1B2.2(if applicable)CONDITIONS1. The change does not affect the reproducibilityand/or consistency of the product.2. No change to the manufacturing method nor to thein-process controls other that those necessitatedby the change in batch-size, e.g. use of differentsize equipment.3. Finished product release and end of shelf lifespecification remains the same.SUPPORTING DOCUMENTS1. Comparative tabulated format of the proposed andNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 467
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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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