DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)If in the opinion of the NPCB, changes made in the sourcing of keyintermediates, route of synthesis, facility or other production, require thatreassessment be made.REFERENCES AND GUIDELINESa) Guidelines on the Technical Requirements Related to the Quality of ActivePharmaceutical IngredientsThe technical requirements related to the quality of active pharmaceuticalingredients have already been addressed elsewhere, (such as in the ASEAN,WHO, ICH, EDQM and EMA guidelines), and applicants are advised to refer tothese guidelines available at the relevant website such as:The ASEAN Common Technical Dossier (ACTD) For The Registration OfPharmaceuticals For Human Use Organization Of The Dossier(http://portal.bpfk.gov.my/index.cfm?menuid=46&parentid=15)The Common Technical Document For The Registration Of PharmaceuticalsFor Human Use: Quality – M4Q(R1)(http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf)Guideline on Impurities on New Drug Products.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2__Guideline.pdfGuideline on Impurities in New Drug Substances Q3Ahttp://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3A_R2/Step4/Q3A_R2__Guideline.pdfGuidelines on Impurities: Guideline For Residual Solventshttp://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Step4/Q3C_R5_Step4.pdfGuideline on Submission of Documentation for a Multisource (Generic)Finished Pharmaceutical Product (FPP): Quality Parthttp://apps.who.int/prequal/info_general/documents/TRS970/TRS_970-Annex4.pdfGuideline on Active Pharmaceutical Ingredient Master File (APIMF)Procedure.(http://apps.who.int/prequal/info_applicants/Guidelines/APIMF_Guide.pdf)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 326
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 | 327
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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