DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Recombinant proteins:- Insulins- Hormones- Erythropoetins and other hematopoietic factors- Cytokines: Interferons, interleukins, colony-stimulating factors, tumournecrosis factors.But does not include:Metabolites from microorganisms; e.g. antibiotics and some hormones;Macromolecules produced by chemical synthesis; e.g. peptides/ oligonucleotidesproduced by chemical synthesis;Whole blood or cellular blood components.Note:This document is not intended to apply on the control of geneticallymodified live organisms designed to be used directly in humans, e.g. livevaccinesFor details, please refer Appendix 3: Guideline on Registration of Biologicsand Guideline on Registration for Biosimilars in Malaysia1.2.3 GENERICSA generic product is a product that is essentially similar to a currentlyregistered product in Malaysia. However, the term generic is not applicable toBiologics.Generics may be further classified into two groups:1. Scheduled Poison(Known as Controlled Medicine/ Controlled Poison)Products containing poisons as listed in the First Schedule underPoisons Act 1952.National Pharmaceutical Control BureauFirst Edition, January 201334
Drug Registration Guidance Document (<strong>DRGD</strong>)2. Non-scheduled Poison(Known as Non-Poison or “Over-the-Counter”, OTC)Products containing active ingredients which are not listed in theFirst Schedule under Poisons Act 1952; and is excluding activeingredient which is categorized under health supplements or naturalproducts or cosmetics.1.2.4 HEALTH SUPPLEMENTSA Health Supplement (HS) means any product that is used to supplement a dietand to maintain, enhance and improve the health function of human body. It ispresented in small unit dosage forms (to be administered) such as capsules,tablets, powder, liquids and shall not include any sterile preparations (i.e.injectables, eyedrops). It may contain one or more, or the following combination:i) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, andother bioactive substances;ii) Substances derived from *natural sources, including animal, mineral andbotanical materials in the forms of extracts, isolates, concentrates,metabolite;iii) Synthetic sources of ingredients mentioned in (i) and (ii) may only be usedwhere the safety of these has been proven.For details, please refer to Appendix 4: Guidelines for Registration of HealthSupplements1.2.5 NATURAL PRODUCTSa) Traditional medicine (as defined under the Control of Drugs and CosmeticsRegulations 1984):Any product used in the practice of indigenous medicine, in which the drugconsist solely of one or more naturally occurring substances of a plant, animalNational Pharmaceutical Control BureauFirst Edition, January 201335
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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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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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