藥品說明書標(biāo)簽管理規(guī)定的英文翻譯

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