DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)2.1 GENERAL REQUIREMENTSData to be submitted as general requirement to support an application for productregistration is based on the product category as shown below:(A)FULL EVALUATION (based on ACTD/ ACTR)No. Product Category Part I Part II Part III Part IV1. New Drug Products √ √ √ √2. Biologics √ √ √ √3.Generics(Scheduled Poison)√√NotApplicableNotApplicable4.Generics(Non-Scheduled Poison)√√NotApplicableNotApplicable5.(B)No.1.Health Supplements:Disease Risk ReductionClaims (High)ABRIDGED EVALUATIONProduct Category* Generics(Non-Scheduled Poison)√ √ √ √2.Health Supplements:a) General or Nutritional Claimsb) Functional Claims (Medium)3. Natural Products* Generics (non-scheduled poison) which are evaluated under abridged evaluation include,but not limited, to the following:a) Antiseptics/ skin disinfectants;National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 136
Drug Registration Guidance Document (<strong>DRGD</strong>)b) Locally-acting lozenges/ pastilles;c) Topical analgesic/ counter-irritants;d) Topical nasal decongestants;e) Emollient/ demulcent/ skin protectants;f) Keratolytics;g) Anti-dandruff;h) Oral care;i) Anti-acne;j) Medicated plasters/ patch/ pad; andk) Topical antibacterial.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 137
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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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