DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Step II:5. Certificate of Pharmaceutical Product (CPP)6. CPP Issuing Body7.Is this product licensed to be placed on the market for use in the exportingcountry?(If no, please state the reason)8.Is the product on the market in the exporting country?(If no, please state the reason)9. Date of Issue of CPP10. Date of Expiry of CPP11. Certificate of Free Sale (CFS) (if any)12. CFS Issuing Body13. Date of issue of CFS14. Date of expiry of CFS15. Certificate of Good Manufacturing Practice (GMP)16. Certificate of GMP Issuing Body17. Date of issue of Certificate of GMP18. Date of expiry of Certificate of GMP19.Summary of Product Characteristics(Product Data Sheet)20. Patient Information Leaflet (PIL)21. Attachment of Protocol Analysis22.Attachment of Certificate of Analysis (CoA)(For two batches)* Compulsory for imported products23. Attachment of Specifications and Certificate of Analysis of Active Ingredient24. Other Supporting Documents (if any)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 150
Drug Registration Guidance Document (DRGD)2.1.3 ADDITIONAL INFORMATION ON:A) BIOAVAILABILITY (BA) STUDYFor modified-release products, dosage recommendations and regime must be supportedby bioavailability studies.Studies comparing availability or establishing equivalence of similar products would beuseful.B) BIOEQUIVALENCE (BE) STUDYNote: This requirement is applicable to generics (scheduled poison) only.With the increasing availability of generic products, a mechanism is required to ensure thatsuch products are therapeutically equivalent to the innovators‟ products and are clinicallyinterchangeable.In practice, demonstration of bioequivalence (BE) is generally the most appropriate methodof substantiating therapeutic equivalence between medicinal products. A list of drugsubstances, which, when formulated in oral solid dosage forms, require BE data as aprerequisite for registration, has been established by the authority (please refer to BPFKwebsite at http://www.bpfk.gov.my). This list is updated based on the requirements.Bioequivalence (BE) Study Requirements for Generic Product in Immediate Release,Oral Solid Dosage Form Submitted as a Second Source ApplicationIn general, for a second source application of a generic product (immediate release, oralsolid dosage form), BE study report from the actual manufacturing site must be submittedduring the submission of application for registration. The base of this requirement is due tothe difference in manufacturing site from the first source that may change the characteristicand specifications of a second source product.However, biowaiver can be considered, provided that Comparative Dissolution Profile(CPD) report against the registered first source product is submitted as a surrogate tobioequivalence study conducted for the second source product and all the followingconditions shall be fulfilled.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 151
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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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