DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)IngredientsGeneralClaimsFunctionalReduced RiskReduction ClaimZincA factor inmaintenanceof good healthHelps tometabolizecarbohydrates,fats and proteinCopperA factor inmaintenanceof good healthHelps in theformation of redblood cellManganeseA factor inmaintenanceof good healthHelps tometabolizecarbohydratesand proteinsProbioticsHelps to improvea beneficialintestinalmicrofloraNotes:1. This list is not meant to be exhaustive and will be reviewed from time to time.2. The Authority will nonetheless conduct a detailed evaluation of the evidence included inthe report to ensure that the health claim is substantiated.3. The Authority will be willing to consider review other than the listed above, if thestandards of evidence are consistent with those of the Authority.4. All references must be current.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 228
Drug Registration Guidance Document (<strong>DRGD</strong>)ACKNOWLEDGEMENTSThe National Pharmaceutical Control Bureau acknowledges its indebtedness to themembers from the industries, government agencies and universities as statedbelow, who provided comments and advices during the preparation of theseguidelines.Government agencies:i) Bahagian Keselamatan dan Kualiti Makanan (BKKM), KKMii) Bahagian Perubatan Tradisional & Komplementari, KKMiii) Institut Penyelidikan dan Perubatan (IMR), KKMiv) Kementerian Pertanian & Industri Asas Tani Malaysiav) Unit Perancang Ekonomi, Jabatan Perdana MenteriUniversities:i) Jabatan Pemakanan dan Dietetik, Fakulti Perubatan & Sains Kesihatan,Universiti Putra Malaysiaii) Jabatan Pemakanan dan Dietetik, Fakulti Sains Kesihatan Bersekutu,Universiti Kebangsaan Malaysiaiii) Pejabat Dietetik, Pusat Perubatan Universiti Malayaiv) Program Sains Makanan, Fakulti Sains dan Teknologi, Universiti KebangsaanMalaysiaIndustries/ Associations:i) Biotropic Malaysia Berhadii) Direct Selling Association of Malaysia (DSAM)iii) Federation of Chinese Physician and Medicine-Dealers Association ofMalaysia (FCPMDAM)iv) Malaysian Biotechnology Corporation (BiotechCorp)v) Malaysian Dietary Supplement Association (MADSA)vi) Malaysian Direct Distribution Association (MDDA)vii) Persatuan Industri Farmaseutikal Malaysia (MOPI)viii)Persatuan Pengeluar-pengeluar Ubat Tradisional Melayu Malaysia(PURBATAMA)ix) Perubatan Traditional India Malaysia (PEPTIM)x) Pharmaceutical Association of Malaysia (PhAMA)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 229
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Page 178 and 179: Drug Registration Guidance Document
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Page 214 and 215: ATTACHMENT 1Drug Registration Guida
Page 222 and 223: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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