DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)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 | 328
Drug Registration Guidance Document (DRGD)APPENDIX 7:SPECIAL CONDITIONS FOR REGISTRATION FORPARTICULAR PRODUCT OR GROUP OF PRODUCTSA1. BLOOD PRODUCTSa) Each batch of the products must comply with WHO requirements for theproduct.b) Each batch of the product imported into Malaysia must be accompaniedwith a Batch Release Certificate from the relevant authority in thecountry of manufacture.c) Each batch of the product must be accompanied with a certificateconfirming that the blood or plasma used in the production of the lot istested and found to be negative for HIV antibody, HbsAg, HCV andhigh-risk donors are excluded.d) Each batch of the product must be accompanied with a certificate ofanalysis.2. ETRETINATE/ ACITRETINa) The product shall only be sold or supplied to:i) Dermatologist (Skin Specialist) who are gazetted with the Ministryof Health, Malaysia, or registered with the Academy of Medicine,Malaysia, and National Specialist Registry;ii)A hospital or Institution maintained by the government, having theservices of a skin specialist or registered medical practitioner withexperience in dermatology.b) The container of the product shall be labeled in a conspicuous anddistinct manner, with the following statements:i) “Etretinate/ Acitretin is highly teratogenic.ii)Pregnancy must be avoided during treatment and for at least threeyears after completing treatment.”c) A proper record of product supplied stating the product name, productregistration number, name, address and contact number of purchaser(prescriber) shall be kept and submitted to the Authority upon request.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 329
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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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