DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Step II:3. Characterisationa) Elucidation of Structure and Characteristicsb) Impurities4. Control of Drug Substancesa) Specificationsb) Analytical Proceduresc) Validation of Analytical Proceduresd) Batch Analysise) Justification of Specifications5. Reference Standards or Materials6. Container Closure System7. StabilityPART III: NONCLINICAL DOCUMENTSection A: Table of ContentsNo. Section B: Nonclinical Overview1. Overview of the Nonclinical Testing Strategy2. Pharmacology3. Pharmacokinetics4. Toxicology5. Integrated Overview & Conclusions6. List of Literature CitationsSection C: Nonclinical Written and Tabulated SummariesSection D: Nonclinical Study ReportsSection E: List of Key Literature ReferencesNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 144
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 | 145
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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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