DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 156
Drug Registration Guidance Document (<strong>DRGD</strong>)3.1 GENERAL INFORMATION3.1.1 DEFINITIONS:i) Biopharmaceutical/ Biotechnology Productii) Biologic/ Biological ProductThe term „biopharmaceutical‟ was coined in the 80‟s to define proteins that weremade by recombinant DNA technology [which includes hybridoma technology formonoclonal antibody (mAb) production].Biologic/ Biological product refers to a product whose active substance is madeby or derived from a living organism (plant, human, animal or microorganism)and may be produced by biotechnology methods and other cutting-edgetechnologies. This product imitates natural biological substances in our bodiessuch as hormones, enzymes or antibodies.Biopharmaceuticals/ Biologics/ Biological products can also be defined as:“a protein (including antibodies) or nucleic acid-based pharmaceuticals used fortherapeutic, which is produced by means other than direct extraction from anative (non- engineered) biological source”. This corresponds to the newbiotechnology view (that is, by elimination, it is largely restricted to recombinant/genetically engineered and mAb-based products).The term „Biotechnology product‟ and „Biological product‟ are used to broadlyrefer to all biopharmaceuticals (by the broad biotechnology view).Note: Today, biologics have become inextricably intertwined withbiopharmaceuticals, to the point where they are synonymous. The generalconsensus is that a „Biologic‟ and „Biopharmaceutical‟ are interchangeableterminology, but a biologic might incorporate some other products (e.g. allergenics,somatic cells etc.).Biologics include a wide range of products such as:Vaccines;Blood products;Monoclonal antibodies (therapeutics);Recombinant proteins:- Insulins- Hormones- Erythropoetins and other hematopoietic factors- Cytokines: interferons, interleukins, colony-stimulating factors, tumournecrosis factors.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 157
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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