欧盟企业在中国建议书（2024-2025）特殊医学用途配方食品顾问委员会和婴幼儿营养子工作组（英文）

Europeanchamber中国欧盟商会

FoodsforSpecialMedicalPurposesSub-workingGroupandPaediatricNutritionSub-workingGroup

RecentDevelopments

SectionThree:Goods

In2023,theinfantformulaindustrysawbothdevelopmentsandchallenges.Withnewfoodsafetystandardsbeingintroducedthatareapplicabletoinfantformula(NewStandards)officiallycomingintoforce,1thecooperativemechanismforoverseasonsiteinspectionsbecamesmoother,andanumberofoutstandingformularegistrationsandapprovalswerefinallycompleted.Asof22ndFebruary2024,atotalof1,127formulashadbeenregisteredundertheNewStandards.2However,withthecooperationmechanismforoverseasonsiteinspectionshavingbeencancelledfollowingtheendoftheCOVID-19pandemic,foreignenterprisesonceagainfaceduncertaintyoverrelatedarrangements.

ThedeclineinChina’sbirthrateoverthelastseven

consecutiveyearshasalsohadanadverseimpactontheinfantformulamarket.3In2023,China’simportsofinfantformuladroppedby16percentyear-on-yearto223,000metrictonnes,70percentofwhichcamefromtheEuropeanUnion(EU),4aproportionthatalsodecreasedcomparedwith2022.5

Thefoodsforspecialmedicalpurposes(FSMP)marketcontinuestogrow,drivenbyfactorssuchasChina’srapidlyageingpopulation.6From2017to31stDecember2023,atotalof164FSMPswereapprovedinChina,with70productsapprovedin2023alone.Thiscanbeattributedtotheregistrationandapprovalprocess

1NoticeontheReleaseofNationalFoodSafetyStandardCheese(GB5420-2021)and50otherNationalFoodSafetyStandardsandfourRevisionOrders,NationalHealthCommission(NHC),published18thMarch2021,viewed7thApril2024,<

/sps/s7891/202103/0bdb6c4318724644b40e3f3f894aa88f.

shtml

>

2Dong,L,TakingStockoftheFoodRegistrationStatusofInfantFormulasin2023,Foodmate,26thJanuary2024,viewed8thApril2024,<

http://news.foodmate.

net/2024/01/680087.html

>

3Nationaldata,NationalBureauofStatistics,annuallyupdated,<

https://data.stats.

/easyquery.htm?cn=C01

>

4ChinaDairyTradeMonthlyJanuary2024,NationalDairyIndustryandTechnologySystemDairyEconomyResearchOffice,29thJanuary2024,viewed11thApril2024,<

/cms/show-18625.html

>

5ChinaDairyTradeMonthlyJanuary2023,NationalDairyIndustryandTechnologySystemDairyEconomyResearchOffice,2ndFebruary2023,viewed7thApril2024,<

/s/LMwTX7zsyGgevTh3G1CuSQ

>

6ChineseFSMPEnterprisesDiveintotheBlueOceanofaGlobal$100BillionIndustry,EconomicInformationDaily,12thJuly2023,viewed7thApril2024,<

http://

/food/20230712/6d60eeb0e2264eec8753d00518ea7fc4/

c.html

>

havingbeenacceleratedfrompreviousyears.7On1stJanuary2024,thenewlyrevisedAdministrativeMeasuresfortheRegistrationofFoodsforSpecialMedicalPurposes(AdministrativeMeasuresforFSMP)tookeffect,8whichencourageenterprisestoinnovateandmeetclinicalneeds,andgivesprioritytothereviewofFSMPsforrarediseasesandnewcategoriesnotyetapprovedforurgentclinicalneeds.9Inlinewithmanyotherindustries,theAdministrativeMeasuresforFSMPpromotethehigh-qualitydevelopmentoftheFSMPindustrythroughoptimisedpoliciesandregulations.

ThefollowingrecentlyreleasedregulationsandstandardrevisionshavehadasignificantimpactontheinfantformulaandFSMPindustries:

•On22ndFebruary2023,theNationalFoodSafetyStandardInfantFormula(GB10765-2021),theNationalFoodSafetyStandardOlderInfantFormula(GB10766-2021)andtheNationalFoodSafetyStandardYoungChildrenFormula(GB10767-2021),

publishedbytheNationalHealthCommission(NHC)andtheStateAdministrationforMarketRegulation(SAMR),cameintoeffect.10

•On10thJuly2023,theSAMRpublishedthe

AdministrativeMeasuresfortheRegistrationofInfantandYoungChildrenMilkPowderFormula(AdministrativeMeasuresforInfantFormula),whichsubsequentlycameintoeffecton1stOctober2023.11

•On28thNovember2023,theSAMRpublishedtheAdministrativeMeasuresforFSMP.Theregulation

7Yang,Y,TakingStockoftheRegistrationandApprovalStatusofFSMPin2023,Foodmate,17thJanuary2024,viewed8thApril2024,<

http://news.foodmate.

net/2024/01/679393.html

>

8AdministrativeMeasuresfortheRegistrationofFoodsforSpecialMedicalPurposes,SAMR,28thNovember2023,viewed7thApril2024,<

https://www.samr.

/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_9b1a9daffc084d819bb4d7a31d909452.

html

>

9XinhuaReleasesReviewofHotSpotsintheChineseFSMPIndustryin2023,SAMR,5thJanuary2024,viewed7thApril2024,<

/tssps/

sjdt/gzdt/art/2024/art_7eb41fe4351047cba729ce852a0920ea.html

>

10NoticeontheReleaseofNationalFoodSafetyStandardCheese(GB5420-2021)and50otherNationalFoodSafetyStandardsandfourAmendments,NHC,18thMarch2021,viewed8thApril2024,<

/sps/s7891/202103/0bdb

6c4318724644b40e3f3f894aa88f.shtml

>

11AdministrativeMeasuresfortheRegistrationofInfantandYoungChildrenMilkPowderFormula,SAMR,26thJune2023,viewed8thApril2024,<

https://www.samr.

/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3a5f8aa921ac4d9e85c2dffe93b05955.

html

>

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cameintoeffecton1stJanuary2024.12

•On8thFebruary2024,theNHCandtheSAMRissuedtheNationalFoodSafetyStandardMilkPowderandModifiedMilkPowder(GB19644-2024).Theregulationwillcomeintoeffecton8thFebruary2025.13

Inthepastyear,theFoodsforSpecialMedicalPurposeandPaediatricNutritionsub-workinggroupshaveactivelyparticipatedintheformulationandrevisionofregulationsandstandardsforspecialfood,clarifiedandoptimisedrelatedprovisionsofthespecialfoodregistrationsystem,andenhancedthestrategicpositionofinfantformularegistrationintheEU-ChinaHigh-LevelEconomicandTradeDialogue.Bothsub-workinggroupswillcontinuepromotingthedevelopmentofregulationsandstandardswiththeaimofacceleratingthehigh-qualitydevelopmentofthespecialfoodindustryinChina.

KeyRecommendations

1.OptimisetheRegistrationSystemfor

SpecialFood

1.1AccelerateOverseasOnsiteInspections

forManufacturersthathavePassedtheDocumentationReviewProcesstoGuaranteeInspectionTimelinesaretheSameforOverseasandDomesticManufacturers

Concern

ThelackofatimelineforoverseasonsiteinspectionscreateschallengesforoverseasapplicantstryingtoregisterinfantandyoungchildrenmilkpowderformulaandFSMP,increasingtheriskofsupplydisruptions.

Assessment

Onsiteinspections,animportantpartoftheregistrationprocessthathelpsoverseasenterprisestoorganisetheirplanning,productionandoveralloperations,cametoastopatthebeginningoftheCOVID-19pandemic.TofacilitatetherestartofoverseasonsiteinspectionsforinfantformulaandFSMPmanufacturersduringtheCOVID-19pandemic,theSAMRsigned

12AdministrativeMeasuresfortheRegistrationofFoodsforSpecialMedicalPurposes,SAMR,28thNovember2023,viewed7thApril2024,<

https://www.samr.

/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_9b1a9daffc084d819bb4d7a31d909452.

html

>

13AnnouncementontheReleaseof47NationalFoodSafetyStandardsand6Amendments(2024No.1)IncludingtheNationalFoodSafetyStandardFoodAdditiveUsageStandard(GB2760-2024),NHC,SAMR,8thFebruary2024,viewed8thApril2024,<

:8086/db

>

SectionThree:Goods

memorandaofunderstanding(MoU)withanumberofcountries,authorisingforeignauthoritiestoconducttheseinspections.However,oncetheWorldHealthOrganizationdeclaredanendtothepandemic,responsibilityforinspectionsfelltotheCentreforFoodEvaluation(CFE)oftheSAMR,aspertheprovisionsoftheAdministrativeMeasuresforInfantFormulaandtheAdministrativeMeasuresforFSMP.AlthoughofficiallytheCFEissupposedtocompletetheonsiteinspectionwithin20workingdaysfromtheconfirmedinspectiondate,thisischallengingforoverseasonsiteinspections.Thisisbecause,comparedtoonsiteinspectionsfordomesticenterprises,onsiteinspectionsofoverseasenterprisesrequireadditionaladministrativeprocedures,suchasvisaapplicationsandtravelarrangementsforpersonnelundertakingtheinspections,whichextendstheoveralltimeframe.Thereisthereforeaneed,incasesofoverseasmanufacturerswhoseproductsarenearingtheendoftheregistrationreviewand/orhavenosubstantialsafetyrisks,toformulateanimplementationplanfortheironsiteinspections.Thisshouldincludeestablishingtheinspectiondelegationandcoordinatingtheoverallinspectionitineraryin

advance,inordertopreventseriousdelaystotheprocess.

Atpresent,numerousstandardsrelatedtoFSMParebeingrevised,necessitatingthatFSMPproductsundergoanewroundofregistration.Clarifyingthecriteriaforexemptingmanufacturersfromonsiteinspectionsandimprovingtheefficiencyofoverseasonsiteinspectionswouldhelpenterprisesformulateprocurementandproductionplansinadvance.Thiswouldhelpthemtoavoidmaterialwasteandtoguaranteethecrucialsupplyofproductstospecialpopulations,suchaspatientswithrarediseases,infantswithfoodproteinallergiesandpremature/lowbirthweightinfants.Also,incaseofforcemajeure,theindustryrecommendsthatMoUbesignedtoenableonsiteinspectionstobecarriedoutasscheduled.

Recommendations

•Clarifytheprinciplesofexemptionfromonsiteinspections,andformulateandpublishanannualoverseasonsiteinspectionschedulebasedontheneedsofoverseasenterprises.

•Createanimplementationplanforoverseasonsiteinspectionsbasedontheprogressofregistrationreviewstoensureseamlessinspectionandregistrationofproductsthatarenearingcompletion

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oftheirevaluationand/orhavenosubstantialsafetyrisks.

•ExtendtheMoUasacooperativemechanismunderpinningoverseas,onsiteinspectionsofbothinfantformulaandFSMPproductionfacilities,andapplythemtomorecountriesandregionsintheeventofforcemajeure.

1.2OptimisetheRequirementsforStability

Testing

Concern

Ininstanceswhenamanufacturer’sexistingrecipeshavealreadybeenregisteredandverifiedforstability,therequirementforsubmittingstabilitytestingreportsfornewrecipesdelaysregistrationandwastesresourcesunnecessarily.

SectionThree:Goods

Assessment

FormulascurrentlyregisteredundertheNewStandardshavealreadyundergonestrictstabilitytestingandstatisticaldataanalysis.Giventhatthechangeincompositionofthenutrientcontentprocessedwithsimilartechniquesisalmostthesame,requiringeachformulatoproviderepetitivestabilityreportsforregistrationwillunnecessarilycostsignificanttime.Stabilitytestingusuallytakesatleastsixmonthsorlonger,andthereisalsoanadditionaldeliverytimeforoverseasenterprisestosendsamplestolaboratoriesinChina.Atthesametime,stabilitytestingsoaksupagreatdealoftheCFE’sinspectiondepartment’sadministrativeresources.

Stabilitytestingispartofanenterprise’sinternalproductqualitymanagementsystem.Asthemainpartyresponsibleforfoodqualityandsafety,themanufacturerhasaccumulatedsufficientdataandresearchonstabilityandisfullyabletoensurethequalityandsafetyofaproductduringitstwo-yearshelflife.GiventhatthefirstbatchofformulasundertheNewStandardswasapprovedon28thFebruary2022,14andhavebeenonthemarketthroughoutthisperiod,thehighpassrateofsamplinginspectionsconductedbytheSAMRthroughoutthistwo-yearperiodprovestheirstability.Thenecessityforstabilitytestingofnewformulasshouldthereforebere-evaluatedwhenthereareregisteredformulasthatsharesimilarprocessing

14ApprovalresultsofInfantFormulaRegistrationon28thFebruary2022,CFE,2ndMarch2022,viewed26thApril2024,<

/sldt/sdxx/

yyepfrfcppf_180/pjfb_181/202203/t20220302_4201.html

>

techniques,andtheconditionsunderwhichcompaniescanbeexemptedshouldbeclearlyspecifiedtoavoidwasteandimproveapprovalefficiency.

Recommendation

•Exemptenterprisesfromstabilitytestingwhentheysubmitmodificationandderegistrationinformationwithnewapplicationsforformulasthatusetechniquesandpackingmaterialsthatareidenticaltoformulasthathavealreadybeenapprovedundernewstandards.

2.ContinuetoImproveAllSafetyStandardsRelevanttoSpecialFoods,aswellastheSupportingDocumentationRequiredfortheirRegistration

Concern

Thecurrenttimelinesforrevisingnationalfoodsafetystandardsforspecialfoods,aswellasthesupportingdocumentationforspecialfoodregistrationandrelatedhorizontalstandards,areunclear,whichhasanegativeimpactonbothregistrationrenewalsandthere-registrationofproducts.

Assessment

1)Revisionofstandards

Atpresent,theNationalFoodSafetyStandardGeneralRulesforInfantFormulasforSpecialMedicalPurposes(GB25596-2010),theNationalFoodSafetyStandardGeneralRulesforFoodsforSpecialMedicalPurposes(GB29922-2013)andtheNationalFoodSafetyStandardNutrient-completeFoodsforCancerPatients

areallbeingrevised.Consideringtheirsignificancetospecialpopulationsandtherequirementforregistrationofbothinfantfoodsforspecialmedicalpurposes(iFSMP)andFSMP,thesub-workinggroupsbelievethatestablishingsufficienttransitionperiodswillhelpensurethesmoothimplementationofthesestandardsandtheregistrationprocess.

Basedonpastresearchanddevelopment(R&D),testing,registrationandproductionexperience,industryplayersestimatethataminimum44-to54-monthtransitionperiodisrequiredtoguaranteeseamlessproduction,tradeanddistributionforiFSMPandFSMPproducts.Forcomparison,accordingtorelevantregulationsissuedbytheEU,thetransitionperiodforinfantformulaisfouryearsandfivemonths;foriFSMP

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withhydrolysedprotein,thetransitionperiodisfiveyearsandfivemonths.15

iFSMPandFSMParedesignedtomeetthespecialnutrientrequirementsofpatientswithlimitedcapacitytotake,digest,absorbormetabolise,orthosewithspecificdiseases.Particularlyforpopulationswithrarediseases,iFSMPandFSMPareimportantandirreplaceableproductsforlifesupport.Therefore,ifthesupplyoftheseproductsisdisruptedduetoinsufficienttransitionperiods,therewillbeanegativehealthimpactonthesespecialpopulations,potentiallyleadingtosocialrisks.

2)Revisionofsupportingdocumentationundertheadministrativemeasures

On25thMay2017,theSAMRissuedtheInterpretationofItemsandRequirementsofApplicationDocumentsfortheRegistrationofInfantandYoungChildrenMilkPowderFormula(Trial)(2017RevisedVersion)(ItemsandRequirements),requiringenterprisestosubmitreportsofthreecommercialtrials.16However,forenterpriseswithapprovedformulasandverifiedstability

anduniformityofproducts,thereisnoneedforthreecommercialtrials,whichwouldonlyresultinadditionalproductioncostsandwastedresources.

On26thMarch2021,theSAMRissuedtheAnnouncementonMattersConcerningtheRegistrationofInfantFormulaandYoungChildrenMilkPowderFormula

andarelatedquestionandanswerlist,17guidingapplicantstocarryoutR&Dandtrialproduction,andstandardisingapplicationmaterialsforregistration.However,thematerialsrequiredforapplicationexceedthescopestipulatedintheItemsandRequirements.ApplicantsmustsubmitR&Ddemonstrationmaterialsforformulaadjustments,listingandcomparingalladjustmentsofnutrientstotheoriginalformulaandexplainingthereasonsfortheadjustmentsonebyone.

15Consolidatedtext:CommissionDelegatedRegulation(EU)2016/127of25September2015supplementingRegulation(EU)No609/2013oftheEuropeanParliamentandoftheCouncilasregardsthespecificcompositionalandinformationrequirementsforinfantformulaandfollow-onformulaandasregardsrequirementsoninformationrelatingtoinfantandyoungchildfeeding,EUR-Lex,17thMarch2023,viewed6thMay2024,<

https://eur-lex.europa.eu/legal-content/EN/

TXT/?uri=uriserv%3AOJ.L_.2016.025.01.0001.01.ENG

>

16InterpretationoftheItemsandRequirementsofApplicationDocumentsfortheRegistrationofInfantandYoungChildrenMilkPowderFormula(Trial)(2017RevisedVersion),SAMR,25thMay2017,viewed10thApril2024,<

https://www.

/tssps/zcwj/art/2023/art_05b7d5e6e7634c789b74c58f826e8ce5.html

>

17AnnouncementonMattersConcerningtheRegistrationofInfantandYoungChildrenMilkPowderFormula,SAMR,26thMarch2021,viewed10thApril2024,<

/tssps/zcwj/art/2023/art_8c35b50883724cbba59f519d291

66e9d.html

>

However,differentformulasoftenfollowdifferentR&Dmethodologies,makingitdifficulttobothindividuallycomparethelabeldeclarationandrecipedosageandthoseoftheadjustedformulaandprovideanexplanation.

SectionThree:Goods

On1stJanuary2024,theAdministrativeMeasuresforFSMPcameintoeffect.Article8ofthesemeasurespointsoutthatclinicaltrialreportsmustusuallybesubmittedduringtheregistrationofspecificnutrient-completeFSMPs.GiventhefactthatFSMPsareproductsfornutritionalsupportonly,thenecessityoftheirclinicaltrialsshouldbedemonstrated.Enterprisesneedclearerguidanceontherequirementsforclinicaltrialsduetothelargeamountoftimeandinvestmentrequired.Withoutthis,enterpriseswillnotbemotivatedtocarryoutR&Dofspecificnutrient-completeFSMPs.Conversely,providingmoreflexibilityinthedesignofclinicaltrials,suchasbytakingproductsinforeignmarketsascontrolgroupsandsharingclinicaltrialdataforsimilarformulas,enterpriseswillbeincentivisedtoengageinR&Dactivities.

Inaddition,theAdministrativeMeasuresforFSMPrequiretechnicalrequirementstobestatedontheregistrationlicenceanditsattachment.However,thereisnosupportingdocumentationthatprovidesaninterpretationofthetestingmethodsforsuchtechnicalrequirements,causinguncertaintyovertheregistrationofnewproducts.Takingthedegreeofhydrolysisasanexample,enterprisesfollowdifferenttestingmethodstoverifythedegreeofhydrolysisduetothelackofarelevantnationalstandard.Eveniftherewassucha

standard,giventhatthetestingresultandreproducibilityofpeptidemolecularweightdistributionaregreatlyaffectedbypre-treatmentandseparatingcolumns,therecouldbetestingdeviationsbetweendifferentmethodsforthesameproduct,orforthesamemethodcarriedoutbydifferentlaboratories.Takingosmoticpressureasanotherexample,thereisnonationalstandardoutliningeithertheacceptedtestingmethodorthetolerancethreshold.Eachenterprisegenerallysetsitsowntestingfrequencybasedonthestabilityofhistoricaltestingresultsoftheosmoticpressureandtherisklevel.Thisunderlinestheneedforclarificationofstandardisedregistrationandotherregulatoryrequirements.

3)Theformulationandrevisionofhorizontalstandards

Wheneverchangesaremadetolabel-relatedregulations,manufacturersmustupdatetheirproduct

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labellingaccordingly,whichisatime-consumingandcostlyprocess.Thishappened,forexample,withtheSAMR’s28thMay2019issuanceoftheAnnouncementontheChangesintheProductNamesofFoodsforSpecialMedicalPurposes,askingenterprisestoadjustFSMPproductnamesonpackaginginaccordancewiththerequirements;18withtheGeneralAdministrationofCustomsinChina’s(GACC’s)12thApril2021releaseoftheRegulationsontheRegistrationandAdministrationofOverseasProducersofImportedFood,19whichrequiredoverseasmanufacturerstoregisterandprinttheproductregistrationnumberonpackaging;andagainon20thDecember2022,whentheSAMRpublishedtheGuidelinesfortheLabellingofFoodsforSpecialMedicalPurposes,20leadingtoyetanotherroundoflabelreplacementformostenterprises.

SectionThree:Goods

Atpresent,horizontalstandardsincludingtheNationalFoodSafetyStandardGeneralRulesforLabellingofPrepackagedFoods(GB7718),theNationalFoodSafetyStandardGeneralRulesforNutritionLabellingofPrepackagedFoods(GB28050),theNationalFoodSafetyStandardLabellingofPrepackagedSpecialDietaryFoods(GB13432),theMeasuresfortheSupervisionandAdministrationofFoodLabels,andtheNationalFoodSafetyStandardStandardsfortheUseofFoodNutritionFortifier(GB14880)areallunderformulationandrevision.Thismeansthat,oncefinalised,industryplayerswillagainneedtoprepareforregistrationbasedonthechangestothesehorizontalstandardsandreviselabelsandpackaging.Ifthesestandardsarenotreleasedatthesametime,enterpriseswillhavetomodifyproductlabelsandpackagingmultipletimes,resultinginconsiderablewasteofpackagingmaterialsandresources,aswellasdisruptionstoproductionandoperationsingeneral.

Recommendations

•IntroduceneworupdatedstandardsforiFSMPandFSMPtotheindustrybeforetheyarepublished,allowingenterprisessufficienttransitiontimebeforetheycomeintoforce.

18AnnouncementontheChangesintheProductNamesofFoodsforSpecialMedicalPurposes,SAMR,30thMay2019,viewed10thApril2024,<

https://www.

/zw/zfxxgk/fdzdgknr/tssps/art/2023/art_72de8751563a42dda3c8bea64

3e89806.html

>

19RegulationsontheRegistrationandAdministrationofOverseasProducersofImportedFood,GACC,12thApril2021,viewed10thApril2024,<

/

gongbao/content/2021/content_5616161.htm

>

20AnnouncementoftheSAMRonIssuingtheGuidelinesfortheLabellingofFoodsforSpecialMedicalPurposes,SAMR,20thDecember2022,viewed10thApril2024,<

/zhengce/zhengceku/2022-12/28/content_5733967.htm

>

•SetatransitionperiodofatleastthreeyearsforiFSMPstandardstoensurebothasmoothregistrationprocessandstablemarketsupply.

•Allowenterprisestodecidethenumberofcommercialtrialsfornewformulasindependentlyfromthosewithbothapprovedformulasandwhosestabilityanduniformityhavebeenverified,whentheproductiontechniquesoftheformulasremainthe

same.

•SimplifytheR&Ddemonstrationmaterialsrequiredforformulaadjustmentssothatonlythechangestothenewformulaneedtobeintroducedwithoutaone-to-onecomparisonwiththeoriginalformula.

•Optimisethetechnicalguidanceforclinicaltrialsofspecificnutrient-completeFSMPsassoonaspossiblebyofferingdifferentiatedmanagementwhensuchtrialsaredeemedunnecessary.

•Giveenterprisesmoreflexibilityinthedesignofclinicaltrials,byallowingthemtouseproductsinforeignmarketsascontrolgroups,andshareclinicaltrialdataforsimilarformulas.

•Reverttothepreviouspracticeforthedegreeofhydrolysisandosmoticpressurethatneedstobeindicatedduringregistration.

•Coordinatethesimultaneousreleaseofrelevanthorizontalstandardstoallowenterprisestocomplywiththemmoreeasilyandavoidunnecessarywasteofresources.

3.IncreaseMarketAccessforandImprove

PublicAwarenessofFSMP

Concern

InChina,thelackofmarketaccessforFSMPhasresultedinalimitedscopeofclinicalapplicationofFSMP,aswellaslowprofessionalandpublicawarenessandaccesstosuchproducts.

Assessment

AlthoughtheFoodSafetyLawstatesthatFSMPshouldberegulatedunderthesamecategoryasotherfoods,duetoitsuseinmedicalandpharmaceuticalinstitutions,FSMPisregardedasanewcategoryderivedfromenteralnutritiondrugs.Asaresult,FSMPisregulateddifferentlyfromfoodintermsofregistration,hospitalaccess,clinicalapplication,chargingandreimbursement.TheapprovalprocedureforFSMPtogainaccesstohospitalsinvolvesthecollaborationofmultipledepartments,includingclinicalnutrition,medical

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services,medicalinsurance,finance,informationandclinical.Although13provincialandsixmunicipalauthoritieshaveissuedadministrativedocumentstoprovideguidelinesonhowFSMPmanufacturerscanprovidetheirproductstohealthcareproviders,21onlyasmallnumberofhospitalshavefullyestablishedacorrespondingmanagementsystem.Inaddition,asFSMPiscurrentlynotincludedinChina’sunifiedHospitalInformationSystemwithcorrespondingchargecodes,physiciansorclinicalnutritionistsareunabletoprescribethem,tothedetrimentofpatientcare.

ThereisalsoalackofaccesstoFSMPoutsideofhospitals,meaningmostproductsarecompletelyunavailabletothepeoplethatneedthemmost.Inaddition,specificnutrient-completeFSMParenotpermittedtobesoldonlineaccordingtotheMeasuresfortheInvestigationandPunishmentofIllegalActsRelatedtoFoodSafetyintheDigitalMarket,22whichfurtherhindersaccesstosuchproducts.Takingspecificnutrient-completeFSMPforcancerpatientsasanexample,patientsandtheirfamiliesfindtheabsenceofanonlinemarketextremelyinconvenient,especiallyforthosethatareadvisednottogooutdoorsorthatliveinremoteareas,particularlyassuchproductsarefrequentlyusedandtendtobeveryheavy.RestrictionsontheonlinemarketalsoadverselyimpactFSMPsalesoverall,whichfurtherdisincentivisescompaniesfromengaginginR&D,particularlygiventhesubstantialinvestmentrequiredforearly-stageclinicaltrials.

Recommendations

•OptimisetheHospitalInformationSystembylistingFSMPproductsw