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 APPLIEDSUPPORTING DOCUMENTS1. Appropriate verification/ validation data andcomparative analytical results between thecurrently approved and proposed test.2. Revised protocol of analysis.3. Certificate of analysis of drug product.17. Change or addition of fillvolume and/or change ofshape or dimension ofcontainer or closure for asterile solid and liquiddrug productP3.4P8E12CD1D2D3(if applicable)Not applicableCONDITIONS1. Release and end-of-shelf life specifications of thedrug product are not affected.2. The packaging material remains the same.SUPPORTING DOCUMENTS1. Justification that the proposed pack size isconsistent with the dosage regimen and durationof use as approved in the package insert.2. Validation data of the manufacturing process,sterilization and container closure system (ifapplicable).3. Stability data of drug product (please refer toASEAN Guideline on Stability Study of DrugProduct) where applicable.4. Revised drafts of the package insert and labelingincorporating the proposed variation, whereapplicable.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 476
Drug Registration Guidance Document (DRGD)APPENDIX 13:SUPPORTING DOCUMENTS REQUIRED FOR CHANGE OFMANUFACTURING SITE (COS) APPLICATIONNoDocument To Be Submitted1. Letter of authorization/ appointment from theproduct owner to authorize Product RegistrationHolder to submit the change of site application.In case of a contract manufacturer, a letter ofacceptance from the proposed contractmanufacturer to manufacture the product.TypeITypeIITypeIIITypeIVTypeV√ √ √ √ √2. Letter from the manufacturer/ product owner toclarify/ explain the need to change site ofmanufacture.For Type I:Letter of declaration stating the reason(s) forchange of manufacturing site and clearly state theproposed and current name and address ofmanufacturer3. Written declaration from the manufacturer to certifythat the manufacturing process, and the releaseand expiry (check) specifications of the product asthe same as already approved.OR√ √ √ √ √√ √ √ √ √If there are minor changes, to declare the „minorchanges‟ & justify the need for such changes.4. „Release‟ and „end-of-shelf life‟ specifications fromproposed site. √ √ √ √ √5. Original copy of the Certificate of Free Sale (CFS)and Good Manufacturing Practice (GMP)/Certificate of Pharmaceutical Product (CPP) fromthe source country of the new manufacturing site inthe case of an imported productOR√ √ √ √ √Letter of confirmation on GMP status or validmanufacturer‟s license for the new manufacturingsite.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 477
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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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