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AdministrativeRegulationforInsertandpackagingLabelsofdrug
(SFDAOrderNo.24)
StateFoodandDrugAdministrationOrder
No.24
“AdministrativeRegulationforInsertandpackagingLabelsofDrug”hadbeenevaluated&agreedbythemanagementmeetingofSFDAbyMar.10,,andpublishhere,thesametobeimplementedsinceJune1st,.
SFDADirector:ShaoMingLi
Mar.15,
AdministrativeRegulationfortheInsertandPackagingLabelsofDrug
SectionI Generalrules
No.1 Forstandardizingtheadministrationfortheinsertandpackaginglabelsofdrugonthebasisof“DrugAdministrationlawoftheP.R.ofChina”and“RegulationsforImplementationoftheDrugAdministrationLawoftheP.R.ofChina”.
No.2 Relevantinsertsandpackaginglabelsforallthedrugswhicharesoldinchinatobeinlinewiththerequirementsfrompresentregulation.
No.3 TheInsertsandpackaginglabelsofdrugsshouldbeapprovedbySFDA.
Thepackaginglabelsofdrugstobedraftedaspertheinsert,theirtextshouldnotexceedtherangeofinsert,andshouldnotcontainthecharacterandmarkwhichsuggeststheefficacy,misleadusesandunsuitablepublicitytheproduct.
No.4 Thelabelshouldbeprintedorstickledonthepackagefordrugasperrelevantregulations,andcan’tcarryanyothercharacter,audiovisual,ormaterialforintroductionorpublicationpropagandaforproductand/ormanufacturer.
Thesmallestpacksoldinmarketfromthepharmaceuticalmanufacturershouldcontaininsert.
No.5 Thetextexpressionfordrug’sinsertandlabelsshouldbescientific,standardandaccurate.ThetextexpressionfortheinsertforOTCdrugshouldbeeasyforunderstandingforthepatientswhomcouldbeabletoselfjudges,selectsanduses.
No.6 Thetextofdrug’sinsertandlabelsshouldbeclearandeasytobedifferentiated,themarkshouldbeclearandstriking,theappearancewithdroppingwordsorunsticketc.shouldnotappear,andcan'tbemodifiedorsupplementedbysticking,cuttingoraltering.
No.7 ThestandardCh.CharacterpublishedbyStateSpokenandWrittenLanguageCommitteeshouldbeusedfortheinsertandlabelsofdrug,theCh.Characterexpressionwillbethecriterionwhenhasadditionalotherlanguageforreference.
No.8 Forthepurposeofprotectingthepublichealthandguidingthedrugtobeusedbyarightandrationalway,thepharmaceuticalmanufacturermayraisesforwardlytoaddthewarningsonthedrug’sinsertorlabels,SFDAalsomayrequirerelevantpharmaceuticalmanufacturertoaddthewarningsontheinsertorlabels.
SectionII Drug’sinsert
No.9 Drug’sinsertshouldcontaintheimportantandscientificdata,resultsandinformationaboutthesafetyandefficacyofdrug,sothatcanbeabletoguidethesafeandrationalusesofdrug.Thedetailformat,contentsandwrittenrequirementfordrug’sinsertaredraftedandissuedbySFDA.
No.10 Theexpressionofthediseasenames,pharmaceuticalspecializednouns,drugname,clinicaltestnamesandresultsinthedrug’sinsertshouldusethespecialandstandardvocabularyorthatoneissuedbystate,andtheweightsandmeasurestobeinlinewiththerequirementsofnationalstandard.
No.11 AlltheAPIsorcrudedrugsintheformulatobelistedinthedrug’sinsert.AlltheexcipientsfortheinjectionandOTCdrugsarealsotobelistedintheinsert.
That’stobeindicatediftheformulacontainstheingredient(s)orexcipient(s)whichmaycauseaseriousadversereaction.
No.12 Thepharmaceuticalmanufacturershouldtrackforwardlythesafetyandefficacystatusofdrugpostmarket,andshouldraisetheapplicationintimeforthemodificationofdrug’sinsertifnecessary.
Accordingtothemonitorresultsfortheadversereactionsofdrugandthere-evaluationofdrug,SFDAalsomayrequirethepharmaceuticalmanufacturertomodifythedrug’sinsert.
No.13 Thepharmaceuticalmanufacturershouldinformthemodifiedcontentstorelevantpharmaceuticalbusinesscompanies,usedunitsandtheconcerneddepts.immediatelyafterthemodifiedinsertwasapproved,andimplementthemodifiedinsertandlabelsintimeaspertherequirements.
No.14 Drug’sinsertshouldcontainenoughinformationofadversereactionsofdrug,andindicatetheadversereactionsindetail.Ifthepharmaceuticalmanufacturerhadnotmodifiedtheinsertintimeonthebasisofthesafetyandefficacystatusofdrugpostmarketordidn’tindicateenoughtheadversereactionsofdrugintheinsert,theharmfulresultcausedtobebornebyrelevantmanufacturer.
No.15 Theapprovaldateandreviseddateofdrug’sinserttobeindicatedclearlyintheinsert.
SectionIII Labelsofdrug
No.16 Thelabelsofdrugrefertothecontentswhichareprintedorpastedinthepackageofdrug,itdividesintointernallabelorouterlabel.Theinternallabelreferstothatlabelusedforimmediatepack,andtheouterlabelreferstothatlabelsusedforotherpacksexceptinternallabel.
No.17 Theinternallabelofdrugshouldcontainthecontentsofgenericname,indicationsorefficacy,strength,dosageandadministrationofdrug,mfgdate,batchNo.expirydate,manufactureretc.
Ifthepacksizeistoosmallandcan’tbeabletocoverallthecontentsabove,atleast,thatcontentsofgenericnameofdrug,strength,batchNo.,expirydateetc.shouldbeindicated.
No.18 Theouterlabelofdrugshouldindicatethecontentsofthegenericnameofdrug,ingredient(s),description,indicationsorefficacy,strength,dosageandadministration,adversereactions,contraindication,warnings&precautions,storage,mfgdate,batchNo.permissionNo.,manufactureretc.Ifthefullcontentsofindicationsorefficacy,dosageandadministration,adversereactions,contraindicationandwarnings&precautionscan’tbeabletobecovered,thenthemajorcontentstobeindicatedandnote“thatdetailsareexhibitedintheinsert”.
No.19 Shipperlabelshouldindicatethenecessarycontentsofthegenericnameofdrug,strength,storage,mfgdate,batchNo.,expirydate,permissionNo.,manufactureretc.,alsomayindicatethepackagequantityandtransportwarningsandothermarkifnecessary.
No.20 ThelabelforAPIshouldindicatethenecessarycontentsofdrugname,storage,mfgdate,batchNo.,expirydate,specificationNo.,permissionNo.,manufactureretc.,andalsoindicatethepacksideandthetransportwarnings.
No.21 Forthesamedrugwithsamestrengthandpacksizefromthesamepharmaceuticalmanufacturer,thetext,formatandcolorofthelabeltobesame,forthedifferentstrengthorpacksize,thelabelshouldbeclearlydifferentorthestrengthtobeindicatedclearly.
ThesamedrugfromthesamepharmaceuticalmanufacturerwhichisadministeredforprescriptiondrugaswellasOTCdrug,thecolorforbothpackagesshouldbeclearlydistinguishedrespectively.
No.22 Forthedrugwhichstoragehasspecialrequirement,thestoragetobeindicatedinastrikingplaceofthelabel.
No.23 Theexpirydateinthelabelofdrugshouldbelabeledasperthesequenceofyear-month-date,theyearisexpressedas4numerals,themonthandthedateisexpressedas2numeralsrespectively.Thedetailformatislabeledasexpiryby“XXXXyearXXmonth”or“expirybyXXXXyearXXmonthXXdate”,alsomaybelabeledas“expirybyXXXX.XX.”or“expirybyXXXX/XX/XX”etc.withthenumeralorothersymbol.
TheexpiryperiodforpreventativebiologicalproductsshouldbelabeledaspertheSFDAapprovalspecification.Forthebiologicalproductsfortreatment,theexpiryperiodtobecountedsincetherepackagingdate,butforotherdrugs,thattobecountedsincemfg.Date.
Iftheexpiryperiodislabeleduptothedate,thentheexpirydateshouldbethepreviousdatecorrespondingtheyear-month-dateagainsttheinitialdate.Iftheexpiryperiodislabeleduptothemonth,thentheexpirydateshouldbethepreviousmonthcorrespondingtheyear-monthagainsttheinitialdate.
SectionIV Useofdrugnameandregisteredtrademark
No.24 ThedrugnamelabeledintheinsertandlabelsshouldbeinlinewiththenominatedprinciplefordruggenericnameandbrandnamewhichisissuedbySFDA,andidenticalwiththeapprovalcertificate.
No.25 Thegenericnameofdrugshouldbenotableandoutstanding,itsfont,sizeandcolorshouldbeaccordant,andinlinewiththerequirementsbelow:
Forthehorizontallabel,thegenericnameofdrugshouldbeexhibitedwithintheupperthirdareaatamarkedplace.
Forthestandinglabel,thegenericnameofdrugshouldbeexhibitedwithinthethirdareaofrightatamarkedplace.
Thefontwhichisnoteasytobeidentified,i.e.grasshand,sealcharactercan’tbeselected,andthefontcan’tbemodifiedwithitalic,centralemptily,hatchingformsetc.
Thecoloroffontshouldbeblackorwhite,toproduceastrongcontrastagainstthetintordarkbackground.
Thegenericnamecan’tbewrittenindifferentrowsexceptthepacksizeistoosmallandthefullnamecan’tbeexhibited.
No.26 Thebrandnamecan’tbesetinthesamerowwiththegenericname,thefontandcolorofbrandnameisnotmoreextrusiveanddistinctthanthegenericname,theareaofsinglefontisnotmorethanthehalfareaofthefontofgenericname.
No.27 ThetrademarkwhichisnotregisteredandotherdrugnamewhichisnotapprovedbySFDAareinhibitivetobeusedfortheinsertan
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