DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)(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 | 180