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时间:2019-10-04
《The Administration of Health Food Registration》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
1、TheAdministrationofHealthFoodRegistrationTheStateFoodandDrugAdministration(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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