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The Administration of Health Food Registration

The Administration of Health Food Registration

ID：43224647

大小：444.00 KB

页数：84页

时间：2019-10-04

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1、TheAdministrationof HealthFoodRegistrationTheStateFoodandDrugAdministration(SFDA)DirectorofDrugsRegistrationXieXiaoyuNov2005TheDefinitionTheLegislationTheorganizationforexaminationandapprovalTheproductrangeforregistrationTheApplication&ApprovalRawmaterials&supplementarymaterialsLabeling,inst

2、ruction,namingTesting,inspectionRe-registrationRe-examinationDeclarationItemsProductRegistration&TheSituationofProductManufacturingHealthFoodI.TheDefinitionofHealthFoodHealthFood：referstothefoodsclaimingtohavespecifichealthcarefunctionsortobetakenasvitaminormineralsupplements.Thatmeansitissu

3、itableforaspecificpopulationwiththeactionstoadjustbodyfunctions.Itisnotintendedtobeusedtotreatanydiseasesanditwillnothaveanyacute,sub-acuteorchronicharmtohumanbody.TwoMajorFeaturesofHealthFood1.“FoodSafety”.Itwillnotexertanyacute,sub-acuteorchronicharmtohumanbody.2.“FoodFunction”.Itcanadjust

4、humanbodyforaspecificpopulation,butitcannottreatdiseases,norsubstituteformedicineasamedicalregimen.TheDifference：（1）TheLikenessandDifferencebetweenHealthFoodandGeneralFoodTheLikeness：Likegeneralfood,healthfoodhasitsownspecificcolor,smell,tasteandshapetosupplyessentialbasicnutrientsforthesurv

5、ivalofhumanbody.HealthFoodToadjustbodyfunctionswithspecifichealthcareactions(asspecifiedonlabel)TobeconsumedbyaspecificpopulationWithaparticulardailydosageGeneralFoodNoemphasisonanyspecificfunctionsTobeconsumedbygeneralpublicNostipulationontheamountofconsumption（2）TheDifferencebetweenhealthf

6、oodandMedicinehealthfoodNomedicaltreatmentobjective,butmainlyusedtoadjusttherunningofhumanbody(asspecifiedonlabel)Havenoacute,sub-acuteorchronicharmSuitableforlong-termuseTobetakenorallyMedicineMusthaveanexplicittreatmentgoalaswellascorrespondingindicationsandmajortreatmentarea.Mayhaveadvers

7、eeffectsWithexactexpirydateInformofinjection,topicalmedicine,oraldrug,etcII.TheLegislationThearticle22,23and45ofthe“FoodHygieneLawofthePeople'sRepublicofChina”(AdoptedonOctober30,1995byOrderNo.59ofthePresidentofthePeople'sRepublicofChina)hasspecifi

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