DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)1.5 FEE FOR CERTIFICATESUnder the CDCR 1984, Regulation 16: “The Director of Pharmaceutical Services may issuesuch certification on any matter relating to any product where such certification is requiredby any country importing such a product.”Certificates Fee ValidityIssuance of one (1) Certificate ofPharmaceutical ProductRM 50.002 yearsIssuance of one (1) Certificate of GoodManufacturing Practice (GMP)RM 50.002 yearsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 134
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 | 135
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PART III: NON-CLINICAL DATADrug Reg
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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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