DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)d) REFERENCES FOR BLOOD PRODUCTS:The National Pharmaceutical Control Bureau‟s requirements for registration of bloodproducts are aligned with the scientific guidelines and recommendations for quality, clinicalefficacy and safety and non-clinical of the World Health Organization (WHO), EuropeanMedicines Agency and International Conference of Harmonization (ICH).Where appropriate, the relevant WHO, EMA and ICH guidelines on blood productsshall be consulted in particular the followings:WHO (http://www.who.int/boodproducts/en/index.html)i) WHO Technical report Series 941, Annex 4, Recommendations for production,control and regulation of human plasma for fractionation.ii) WHO Technical report Series 924, Annex 4, Guidelines on viral inactivation andremoval procedures intended to assure the viral safety of human plasma products.iii) WHO Guidelines on tissue infectivity distribution in Transmissible SpongiformEncephalopathies.EMA (http://www.ema.europa.eu)i) EMA/CHMP/BWP/706271/2010 Committee for medicinal products for human use(CHMP) Guideline on plasma-derived medicinal productsii) CHMP/BWP/3794/03 Rev. 1 Scientific data Requirements for Plasma Master File(PMF)iii) CPMP/BWP/268/953AB8A Virus Validation Studies: The Design, Contribution andInterpretation of Studies validating the Inactivation and Removal of Virusesiv) EMEA/410/01 Rev. 3 Minimising the Risk of Transmitting Animal SpongiformEncephalopathy Agents via Human and Veterinary Medicinal Productsv) Guideline on the clinical investigation of recombinant and human plasma-derivedfactor VIII products, European Medicines Agency, EMA/CHMP/BPWP/144533/2009.vi) Note for Guidance on the Clinical Investigation of Human Plasma Derived Factor VIIIand IX products, European Medicines Agency, CPMP/BPWG/198/95REV.1.vii) Guideline on the Clinical Investigation of Human Normal Immunoglobulin forIntravenous Administration (IVIg), European Medicines Agency,EMA/VHMP/BPWP/94033/2007 REV.2.ICH (http://www.ich.org)i) ICH Topic 5QC Quality of Biotechnological products: Stability Testing ofBiotechnological/ Biological Products.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 170
Drug Registration Guidance Document (<strong>DRGD</strong>)3.3 CHECKLISTS3.3.1 Checklist A:Products Containing Animal-Derived Materials WITH a valid TSE risk evaluationCertificate of Suitability (CEP)No. Documents Yes/ No1. TSE Risk Evaluation Certificate of Suitability (CEP)2. Basic information providing a brief description of the following:3. Rationale for using animal-derived materials4.5.6.7.8.9.Source of AnimalsDeclaration of materials of porcine originDeclaration of materials of other animal originDeclaration of the nature of the animal tissue/ parts of animalused.Description of the tissue/ organ-collection procedures andmeasures in place to avoid cross-contamination.Nature and quantity of each animal-derived material used:As a drug substance.As an excipient or adjuvant.As a starting material used in the manufacture of a drugsubstance.As a starting material used in the manufacture ofexcipient.As a reagent or culture media component used inmanufacture.As a reagent or culture media component used inestablishing master cell banks.As a reagent or culture media component used inestablishing working cell banks.Others, please provide detailsDeclaration that the final product does not contain any animalcontainingmaterials with the relevant evidence (if applicable)Other supporting documents e.g. Halal Certification of the animalderived ingredient from a competent Halal Certification Authority.10. Labelling of the animal derived materials.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 171
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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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