DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NoDocument To Be SubmittedTypeITypeIITypeIII6. Original copy of Certificate of Analysis (CoA) fromthe new manufacturing site. √ √ √TypeIVTypeV7. “Accelerated” and on-going stability data as perASEAN Guideline on Stability Study of DrugProduct and a letter of commitment to submit realtime stability data.For Type I:√ √ √ √Letter of commitment to submit stability datareport.8. Amended immediate label, outer label andpackage insert for the product from the proposedsite.√ √ √ √ √9. Process validation report as per ASEAN GuidelineOn Submission Of Manufacturing ProcessValidation Data For Drug Registration.For Type I:√ √ √ √Letter of commitment to submit process validationreport, if applicable10. Declaration and commitment that the manufacturerwill carry out continuous quality monitoring on thepost change products√11. Letter of commitment to submit stability data,certificate of analysis, process validation report(where applicable) and sample for laboratorytesting within 6 months of approval of site change.√12. A written plan for assessing the effect of thechange of site on the quality of the product with theobjective of demonstrating that the pre- and postchangeproducts are equivalent.√ √ √National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 478
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 | 479
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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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