DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 148
Drug Registration Guidance Document (DRGD)a) Bioequivalence study conducted using the registered first source product has beenevaluated by the NPCB and found satisfactory.b) The second source product is the same as registered first source product used in thebioequivalence study in terms of:i) Product formulation;ii) Equipment used in the manufacturing process;iii) Source and supplier of raw material;iv) Quality control and specifications of raw material;v) Manufacturing process of product and standard operating procedures;vi) Environmental conditions during the manufacturing process of product;vii) Quality control and specifications of finished product.c) Comparative Dissolution Profile must be conducted in accordance to ASEANGuidelines for the Conduct of Bioavailability and Bioequivalence Studies including thecalculation of similarity factor (f2) to prove the similarity of these two products.d) Process validation has been conducted on 3 pilot or commercial batches of thesecond source product and found satisfactory by the NPCB.This exemption is not applicable for any new submission of application for registration of afirst source product. BE study must be conducted for this product which ismanufactured at the actual manufacturing site submitted for registration.(Reference: Circular Bil.(10)dlm.BPFK/PPP/07/18Jld.1 , 2 Jun 2011)Starting on 1 st of January 2012, bioequivalence (BE) study is required for all application ofregistrations for generic products containing scheduled poison in the form of immediaterelease, oral, solid dosage form whereas renewal of registered products, the effective dateis on 1 st January 2013.(Directive Arahan di Bawah Peraturan 29, Peraturan-peraturan Kawalan Dadah danKosmetik 1984 Bil. 1 Tahun 2011, 2 March 2011 Bil (10) dlm BPFK/PPP/01/03 Jld 1)Sponsors or BE study centers are compulsory to notify the Authority pertaining to all BEstudies which do not require Clinical Trial Import Licence (CTIL) or Clinical TrialExemptions (CTX) and are going to be done at either local or overseas BE study centersfor registered products or products to be registered in Malaysia (Directive Arahan di BawahPeraturan 29, Peraturan-peraturan Kawalan Dadah dan Kosmetik 1984 Bil. 13 Tahun 2011,14 October 2011, Bil (23) dlm BPFK/PPP/01/03 Jld 1).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 149
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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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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