DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)6. Animal derived materials/ products are commonly used in the manufacture of biologics/biopharmaceuticals. Please provide detail information regarding the rationale for use ofsuch material, the source etc., as per Checklist A and Checklist B; and also provide aconfirmation on the presence/ absence of the animal materials in the final product.7. Since biosimilars are follow-on products of the original biopharmaceutical products(well-characterised recombinant proteins), this document also is applicable tobiosimilars. Additionally, a separate Guideline for Registration of Biosimilars isavailable.8. This document is intended to provide guidance for the registration of biologics.However, the document will serve as a living document that will be updated/ revisedfurther in the line with the progress in scientific knowledge and experience.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 152
Drug Registration Guidance Document (<strong>DRGD</strong>)Outline:3.1 General Information3.1.1 Definitions3.1.2 Introduction3.2 Specific Requirements for Registration of Biologics3.2.1 Requirements for Registration of Biologics(Vaccines and Biotechnology Products)a) Vaccinesi) Definition of Vaccineii) Requirements for Registration of Vaccines(Chemistry, Manufacturing And Controls, CMC)b) Biotechnology Productsi) Definition of Biotechnology Productii) Additional Requirements for Registration of BiotechnologyProductsc) References3.2.2 Requirements for Registration of Blood Productsa) Definition of Blood Productb) Requirements for Registration of Blood Productsc) Checklist of Plasma Master File for Blood Productsd) References3.3 Checklists of Registration for Products Containing Materials ofAnimal Origin:3.3.1 Checklist A: Products Containing Animal-Derived Materials witha valid TSE risk evaluation Certificate of Suitability(CEP)3.3.2 Checklist B: Products Containing Animal-Derived Materialswithout a valid TSE risk evaluation Certificate ofSuitability (CEP)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 153
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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