DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)PART IV: CLINICAL DOCUMENTNo.Section A: Table of ContentsSection B: Clinical Overview1. Product Development Rationale2. Overview of Biopharmaceutics3. Overview of Clinical Pharmacology4. Overview of Efficacy5. Overview of Safety6. Benefits & Risks ConclusionsNo.Section C: Clinical Summary1. Summary of Biopharmaceutics Studies and Associated Analytical Methods2. Summary of Clinical Pharmacology Studies3. Summary of Clinical Efficacy4. Summary of Clinical Safety5. Synopses of Individual StudiesSection D: Tabular Listing of all Clinical StudiesSection E: Clinical Study ReportsSection F: List of Key Literature References, Published Clinical Papersand Latest Periodic Safety Update Report (PSUR)Notes:* Evaluated by Centre for Quality Control. For details, please refer to Section C:Quality Control in the main DRGD.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 136
Drug Registration Guidance Document (DRGD)2.1.2 GENERAL REQUIREMENTS FOR ABRIDGED EVALUATIONNo.Step I: Product Validation1. Product Name2. Dosage Form3.4.Active Ingredient(s)a) Active Ingredient nameb) Strength of Active Ingredient (Quantity unit per dose)c) Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine orOthers/ Plant/ Others)d) Form of Active Ingrediente) Remarks (if any)Excipient(s)a) Excipient nameb) Strength of Excipient (Quantity unit per dose)c) Function of excipient (e.g. absorbent, diluents, bulking agent, coatingagent, anti-caking agent etc.)d) Source of excipiente) Remarks (if any)5.Is there any source of ingredients derived from animal origin, includingactive ingredient? (Yes/ No)6. Manufacturer (Name and Address)7. Is the selected manufacturer a contract manufacturer? (Yes/ No)8.9.Is the product from second source? (Yes/ No)If yes, please provide:a) Letter of declaration stating that this product is a second sourceproductb) Registration number and product name of the first sourceIs this product containing any premix? (Yes/ No)a) State your premix formb) Manufacturer namec) Manufacturer addressd) Certificate of Good Manufacturing Practice (GMP)e) Formulationf) Manufacturing Processg) Specification of Analysish) Certificate of Analysis (CoA)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 137
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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