DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)APPENDIX 2:REQUIREMENTS FOR PRODUCT REGISTRATIONIMPORTANT NOTES:1. This appendix is for reference purpose only, where applicable, and it may notfollow the sequence as in the online product registration application forms (inQUEST system).2. Online application forms are available for different product categories.3. Applicant shall follow and comply with all requirements in the online applicationforms as well as any supplementary documentation requested by the Authority,whichever it may deems fit.This appendix comprises of two (2) parts which are:2.1 General requirements for:2.1.1 Full Evaluation;(In accordance to ASEAN ACTD/ ACTR or ICH guidelines)• Part - I Administrative data and product information• Part - II Data to support product quality (Quality Document)• Part - III Data to support product safety (Nonclinical Document)• Part - IV Data to support product safety and efficacy (ClinicalDocument)2.1.2 Abridged Evaluation.2.1.3 Additional Information on Requirement of:• Bioavailability (BA) Study• Bioequivalent (BE) Study2.2 Product Specific RequirementsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 132
Drug Registration Guidance Document (DRGD)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 | 133
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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