DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Strength of active ingredient :To enter the content of active ingredients (numerical) and then select the weightsand measures from the given list.Content of ingredients shall be expressed as appropriate in the following manner:a. quantity per dose unit (e.g. for unit dose formulations - tablet, capsule, lozenge,etc.)b. percentage composition - %w/w, %w/v, %v/v, etc.c. weight per ml. (e.g. for solutions,suspension etc.)d. quantity (percentage or amount) per measured dose (e.g. oral liquids, drops,etc.)Metric weights and measures shall be used.Source of Active ingredient:To specify the source such as animal, plant, synthetic or others (to specify)Remarks on active ingredient (if any):To specify the equivalent/providing amount of active component from the rawmaterial (e.g: Sodium ascorbate 520 mg providing.... Vitamin C)Declaration of species name from natural source (plant, animal or others)Table 6: Additional data to support a new health supplement active ingredients:No. Types of documents Checklist1.2.Standard/ establishedreferencesInformation from thecompetent authorities ofreference countriesMartindale, Pharmacopeias, Monographetc.Information shall be provided from thecompetent authorities of referencecountries (Refer to 9.6.5)Example of supporting documents:‣ Registration status and maximumregistered dosage as healthsupplement‣ established monograph‣ GRAS statusNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 188
Drug Registration Guidance Document (<strong>DRGD</strong>)No. Types of documents Checklist3.4.5.Clinical studies or scientificevidencesNon-clinical studies to supportlong term-useToxicology studies with thedetermination of NOAEL (Noobserved adverse effect level)Full published articlesUnpublished data may be consideredMandatory for high claim6. Pharmacological study7.Justification for the use of newactive ingredient as healthsupplement8. Registration status worldwide Registered and Marketed DateNote: The documentation must support the safety use and dose of new active ingredientsas a health supplement.4. ANY ANIMAL ORIGINAny source from animal origin must be declared and to specify the type of animal.5. MANUFACTURERManufacturer is defined as “A company that carries out at least one step ofproduction as well as the final release of the finished product”.The requirements for Good Manufacturing Practice (GMP) of the premises are in Table 7as followed:National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 189
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Page 138 and 139: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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