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1、KoreanRegulations MarketEntryRequirements CaseStudy Sung SickWoo Ph D ChiefOperatingOfficer ChiefScientificOfficerUnigen Inc NutraconChina2005December3 4 2005 OverviewofHealthFunctionalFood HFF MarketinKorea GlobalSupplementSalesbyRegion 2003 Source NutritionBusinessJournal 2004 J FoodTechnology 200
2、3 Unit USDbillion 1 1 150Won KoreaHealthFunctionalFoodMarketTrends 2002 2006 Source FoodIndustry 2004 MaeilEconomy 2005 HFFActwasenactedin2003 Unit USDmillion KRWbillion PerCapitaGNI HouseholdExpenditure MonthlyHouseholdSupplementExpenditure KoreaHealthFunctionalFoodExpenditureTrends 1996 2004 Sourc
3、e KoreaNationalStatisticalOffice Unit 10 000Won ThegrowthrateofHFFexpenditurehasbeenexceedingthegrowthratesofpercapitaGNIandhouseholdexpenditureexceptduring Asiafinancialcrisis Unit 10 000Won 199619971998199920002001200220032004 199619971998199920002001200220032004 TheIncreaseoftheSeniorCitizensinKo
4、rea TheSeniorCitizensareover65yearsold Source NationalStatisticalOffice TheFutureEstimatedPopulation 2001 KoreaHealthFunctionalFoodSalesbyChannelin2004 Thesalesinthemassmarkethavebeencontinuouslyincreasing speciallythroughconvenientStores Over70 ofthedrugstoresaresellingHFFitems Thesalesthroughhomes
5、hoppingchannelandinternetarerapidlygrowing Source KoreaHealthSupplementAssociation Surveyresultsfromleading25companies Feb 2005 1 1 150Won KoreaHealthFunctionalFoodIntakePatterns 2004 IntakeHistory IntakeHistorybyAgeGroup ReasonsofIntake Source 2004ConsumerSurveyResultsbyKoreaHealthSupplementAssocia
6、tion SurveyResultsofConsumerTrend 2004 Source BioFoodNetWork 2005 KoreaHealthFunctionalFoodSalesbyItemCategory 2003 Unit USDmillion 1 1 150Won Source 2004KoreaHealthFunctionalFoodSalesbyKoreaFood DrugAdministration KFDA Aloerelatedsaleswere20 ofthetotalHFFsalesin2004and12 ofthegrowthisexpectedin2005
7、 ResearchInstitution n 35 ResearchStatusofHealthFunctionalFoodinKorea 2004 InProgress 85 3 n 58 InProgress 82 9 n 29 Source BioFoodNetWork 2005 NotInProgress 14 7 n 10 NotInProgress 17 1 n 6 CurrentResearchItems CurrentResearchItems Company n 68 ImplementationofHealthFunctionalFoodAct HealthFunction
8、alFoodAct HFFA ObjectivesToenhancepublichealthandconsumerprotectionToensuresafetyandqualityofHealthFunctionalFood BackgroundNov 29 00HFFAwasproposalbytheNationalAssembly CongressManMSKim Aug 26 02HFFAwasdeclaredDec 18 03DecreeofHFFAwasenforcedJan 31 04Rules RegulationsofHFFAwereenforcedNov 10 05Revi
9、sionofHFFAwasproposed safetyevaluationprocess approvalperiod formsofrequireddocuments etc July 31 06RevisedHFFAwillbeenforcedorJan 01 07 Chapter1 GeneralprovisionChapter2 RequirementforbusinessChapter3 Standard specification labelingandadvertisementChapter4 AuditandInspectionChapter5 Gooddietaryheal
10、thsupplementmanufacturingpracticeChapter6 ProhibitionofspecifictypesofsalesChapter7 Establishmentofadvisorycommittee organizationChapter8 AdministrativesanctionChapter9 SupplementaryprovisionChapter10 Legalresponsibility penalty HealthFunctionalFoodAct cont d HealthFunctionalFoodAct cont d Defines H
11、ealthFunctionalFood as Aproductthatisintendedtousetoenhanceandpreservethehumanhealthbythefunctionalfoodingredients Aproductthatisintendedforingestionintablet capsule powder granule pillorliquidform AuthorizesKoreaFood Drugadministration KFDA toregulate HealthFunctionalFood Nutrition FunctionalFoodHe
12、adquarterHealthFunctionalFoodTeamHealthFunctionalFoodStandardTeam Pre marketapprovalismandatoryRequiresevidencesthatanewactivefoodingredientissafeandeffectivebeforemarketing ifitisnotintheexistinglistofhealthfunctionalfoodingredientsand orifapetitionerwantsspecificclaim s GenericandProduct specificH
13、FFRequiresestablishingstandardsandspecificationsofaproductcontainingpre approvedactivefoodingredient s beforemarketing ProhibitionNofalselabelingnorexaggeratedadvertisementsthatmaycauseconsumerstoconfuseHFFwithmedicines Conventionalfoodmanufacturerscanuseneitherlabelingnoradvertisementofhealthclaim
14、Thelawprohibitsmisrepresentations displaysorsalesandmarketingofconventionalfoodresemblingtoHFF HealthFunctionalFoodAct cont d OrganizationofKFDAbeforeNov 2005 KFDACommissioner DeputyCommissioner Audit InspectionOffice FoodStandardDivisionHealthFunctionalFoodStandardDivisionFoodAdditivesTeamDivisiono
15、fNutritionEvaluation CenterforFoodSafetyEvaluation DrugEvaluationDepartment HerbalMedicinesEvaluationDepartment BiologicsEvaluationDepartment MedicalDevices RadiationHealthDepartment NationalInstituteofToxicologicalResearch GeneralServicesDivision Planning ManagementOffice FoodSafetyBureau Pharmaceu
16、ticalSafetyBureau SafetyEvaluationOffice FoodSafetyDivisionFoodSurveillanceDivisionFoodDistributionDivisionHealthFunctionalFoodDivision CenterforFoodStandardEvaluation NewOrganizationofKFDAafterNov 2005 KFDACommissioner DeputyCommissioner AuditOffice Innovation HumanResourcesManagementOffice PolicyManagement PublicRelationsHeadquarter FoodHeadquarter Nutrition FunctionalFoodHeadquarter HealthFunctionalFoodTeamHealthFunctionalFoodStandardTeamNutritionalEvaluationTeamFoodAdditivesTeam Pharmaceutic
