DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)(i) Table 1: General or Nutritional ClaimsLevel ofclaimDefinitionExamples/Wording ofclaimCriteriaEvidence tosubstantiate HSclaimsGeneralorNutritionalClaims• General HealthMaintenance• Benefits derivedfromsupplementationbeyond normaldietary intake• Supportshealthygrowth anddevelopment• Nourishesthe body• Relievesgeneraltiredness,weakness• Helps tomaintaingood health• For energyand vitality• Is in line withestablished nutritionknowledge inreference texts• Is related to generalwell-being in linewith scientificknowledge• Claim does not referto the structureand/or function ofthe human body• In accordance to HSprinciples andpractice in Malaysia1 or more of thefollowingevidences:i) Standard referencee.g. referencetextbooks,pharmacopoeia,monographsii) Recommendationson usage fromreferenceregulatoryauthorities orreferenceorganisations• Forstrengtheningthe bodyPlease refer to Illustrative Substantiation Evidence List for the list of acceptable references,organisations and authorities.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 182
Drug Registration Guidance Document (<strong>DRGD</strong>)(ii) Table 2: Functional Claims (medium)Claims must be adequately substantiated through ingredient-based evidence and whennecessary through product-based evidence.Types ofHS claimFunctionalClaims(medium)Definition• Maintains orenhances thestructure orfunction ofthe humanbody,excludingdiseaserelatedclaimsExamples/Wording ofclaimsAcceptableclaims basedon the singleingrediente.g.• Vitamin Ahelps tomaintaingrowth, visionand tissuedevelopment• Vitamin Dhelps innormaldevelopmentandmaintenanceof bones andteeth.• Chondroitinhelps topromotehealthy jointsCriteriaFor claims onestablishednutrients andingredients suchas vitamins &minerals withdailyrecommendedvalues• Meet theconditions fornutrient functionclaims as setby the Authority• Claims haveconsistentscientificsupportaccording toscientific reviewand evaluation• In accordanceto HS principlesand practice inMalaysiaEvidence to substantiateHS Claims1 or more of the followingevidence:i) Standard reference e.g.reference textbooks,pharmacopoeia,monographsii) Recommendations onusage from referenceregulatory authorities orreference organisationsiii) Good quality scientificevidence from humanobservational studies(refer to ASEANGuidelines on efficacydata requirement) (only inthe event that humanexperimental study isnot ethical, animalstudies will be acceptedtogether withepidemiological studiesor other scientificliterature anddocumented traditionaluse)iv) Peer-reviewed scientificdata or meta-analysisPlease refer to Illustrative Substantiation Evidence List for the list of acceptable references,organisations and authorities.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 183
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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