DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)pertaining to each API should be submitted with the new online productregistration application.3.6. Assessment of an API will be performed once submission of an applicationfor registration of a product using the said API is made by a ProductRegistration Holder.4. PROCEDURE FOR SUBMISSION4.1 HOW TO SUBMIT4.1.1 The PRH of the product registration shall submit Part 2.S ACTD aspart of product application. Where any information required as perACTD is not available the DMF will be required.4.1.2 The DMF may be submitted via an electronic copy (CD) or a hardcopy(optional) directly to the NPCB to maintain confidentiality of thecontents.4.1.3 The NPCB may accept a CEP issued by European Directorate for theQuality of Medicine (EDQM) in lieu of the DMF of an API.4.2 REQUIRED INFORMATIONThe API information can be submitted to National Pharmaceutical ControlBureau (NPCB) in one of the following three options:• Option 1: Drug Master File (DMF) procedure; or• Option 2: Certificate of suitability of the European Pharmacopoeia(CEP); or• Option 3: Full details of “Part II S ACTD” in the Product DossierThe applicant should clearly indicate at the beginning of the API section (inthe Product Dossier) how the information on the API for each APImanufacturer is being submitted. The API information submitted by theapplicant/ FPP manufacturer should include the following for each of theoptions used.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 312
Drug Registration Guidance Document (<strong>DRGD</strong>)4.2.1 Documents required:Documents required for each option of API Information submissionare summarized as in table below:Table 1:Summary of documents required for API InformationSubmission:OptionOption 1(DMF)Option 2(CEP)Option 3(FullACTD)Documents requiredPart II S ACTD via the online system (Open Partonly)DMF (See Section 5 for details).Current GMP certificate or any other evidence ofGMP compliance from a regulatory authority; and,Certificates of Analysis of API from APIManufacturer and product manufacturer (2batches).Part II S ACTD via the online system (as deemedappropriate)CEP (See Section 6 for details); and,Certificates of Analysis of API from APIManufacturer and product manufacturer (2batches).Full details of Part II S ACTD (See Section 7 fordetails)Current GMP certificate or any other evidence ofGMP compliance from a regulatory authority; and,Certificates of Analysis of API from APIManufacturer and product manufacturer (2batches).4.2.2 In order to gain approval for an API;The data should be sufficient to justify the specifications andtesting of the API (including validated analytical methods).The information should confirm the identity and stability of the APIby providing appropriate structure elucidation and stability studies;and,National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 313
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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