DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Outline:11.1 Product Classification11.1.1 Pharmaceuticals11.1.2 Health Supplements and Natural Products11.2 Submission of Application11.2.1 Step 1: Product Validation11.2.2 Step 2: New Registration Application FormPart I – Administrative Data and Product Information- Section A: Product Particulars- Section B: Product Formula- Section C: Particulars of Packing- Section D: Label (Mockup) for Immediate Container, Outer Carton andProposed Package Insert- Section E/ Section F: Supplementary DocumentationPart II, III & IV – Quality , Nonclinical Document & Clinical DocumentNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 436
Drug Registration Guidance Document (<strong>DRGD</strong>)11.2 PRODUCT CLASSIFICATIONApplicant shall ensure correct product category as listed below in order to determinethe method of evaluation i.e. full evaluation (*) or abridged evaluation (**) in whichavailable as separate modules for application.11.2.1 Pharmaceuticalsi) New Drug Products *ii) Biologicals *iii) Generics (Scheduled Poison) *iv) Generics (Non-Scheduled Poison) (or known as OTC/ non-prescription) -other than listed at v) *v) Generics (Non-Scheduled Poison) **, which include, but not limited to thefollowing:Antiseptics/ skin disinfectants;Locally-acting lozenges/ pastilles;Topical analgesic/ counter-irritants;Topical nasal decongestants;Emollient/ demulcent/ skin protectants;Keratolytics;Anti-dandruff;Oral care;Anti-acne;Medicated plasters/ patch/ pad; andTopical antibacterial.11.2.2 Health Supplements and Natural Products **Application form for registration for Health Supplements; and Natural Products(or termed as Traditional Products) are available under Abridged module.Do not use the pharmaceuticals module for these product categories.11.2 SUBMISSION OF APPLICATIONAny application for a product registration shall follow a 2-step process i.e. Step 1(Product Validation) and Step 2, as described below:National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 437
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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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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