DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Guideline on Summary of Requirements for Active Substances. In TheQuality Part of the Dossier.(http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002813.pdf)Content of the Dossier for Chemical Purity and Microbiological Quality(PA/PH/CEP 04 1 4R)http://www.edqm.eu/medias/fichiers/Content_of_the_Dossier_for_Chemical_Purity_Microbiological_Quality.pdfContent of the Dossier for a Substance for TSE Risk Assessment(PA/PH/CEP (06) 2)http://www.edqm.eu/medias/fichiers/Content_of_the_Dossier_for_a_Substance_for_TSE_Risk_Assessment.pdfCertificates of Suitability for Sterile Active Substances (PA/PH/Exp. CEP/T(06) 13, 1R)http://www.edqm.eu/en/New-Applications-29.htmlCertification database for information on Certificates of Suitability (CEPs)granted by the EDQM.https://extranet.edqm.eu/publications/recherches_CEP.shtmlWHO List of Prequalified Active Pharmaceutical Ingredientshttp://apps.who.int/prequal/info_applicants/API_PQ-List.htmb) Guidelines on Stability TestingThe following Guidelines may be consulted in the context of stability testing:WHO Technical Report Series, No. 953, 2009 Annex 2: Stability testing ofActive Pharmaceutical Ingredients and Finished Pharmaceutical Products(http://www.who.int/medicines/publications/pharmprep/PDF_TRS953_WEB.pdf)International Conference on Harmonisation. ICH Q1A (R2): Stability testing ofnew drug substances and products(http://www.ich.org/LOB/media/MEDIA419.pdf)International Conference on Harmonisation. ICH Q1B: Photostability testing ofnew drug substances and products(http://www.ich.org/LOB/media/MEDIA412.pdf)International Conference on Harmonisation. ICH Q1C: Stability testing of newdosage forms(http://www.ich.org/LOB/media/MEDIA413.pdf).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 324
Drug Registration Guidance Document (<strong>DRGD</strong>)International Conference on Harmonisation. ICH Q1D: Bracketing andmatrixing designs for stability testing of new drug substances and products(http://www.ich.org/LOB/media/MEDIA414.pdf).International Conference on Harmonisation. ICH Q1E: Evaluation for stabilitydata (http://www.ich.org/LOB/media/MEDIA415.pdf).Note for Guidance on Stability Testing: Stability Testing Of New DrugSubstances And Products (CPMP/ICH/2736/99)(http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002651.pdf)Note for Guidance on Stability Testing of Existing Active Substances andRelated Finished Products(www.ema.europa.eu/pdfs/vet/qwp/084699en.pdf)ASEAN Stability Guideline(http://portal.bpfk.gov.my/index.cfm?menuid=46&parentid=15)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 325
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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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