目錄TableofContents1.1范圍11第二條醫(yī)學互動交流活動的基本原則2.1醫(yī)學互動交流活動的基本原則14第三條藥品獲得上市許可之前的信息交流及在藥品標明的適用范圍之4.1藥品信息的一致性4.2準確和不誤導4.3實證20第六條電子版推廣材料，包括音像Article3Pre-ApprovalCommun21第七條與醫(yī)療衛(wèi)生專業(yè)人士的醫(yī)學7.1醫(yī)學互動交流項目7.1.1涉及出國的醫(yī)學互動交流項目7.1.2醫(yī)學互動交流項目中的藥品推7.1.3適當?shù)牡攸c/住宿7.1.4限制7.1.5娛樂7.2支持7.2.1直接支持個人醫(yī)療衛(wèi)生專業(yè)人士7.3服務(wù)費7.4講者項目7.4.1講者項目的目的7.4.2選擇醫(yī)療衛(wèi)生專業(yè)人士講者7.4.3對參會者的要求7.5演示材料的審閱7.6禮品及其他7.6.1禁止提供禮品7.6.2推廣輔助用品7.6.3為提高醫(yī)療及病患服務(wù)的醫(yī)用7.6.4為提高病患服務(wù)的信息及教育7.1.1MedicalInteractionProgramsInvolvingForeignTravel7.1.2PromotionalInformationatMedicalInteractionPrograms7.1.3AppropriateVenue/Accommodation7.1.4Limits7.1.5Entertainment7.2.1DirectSupporttoIndividualHealthcareProfessionals7.4.1PurposeofSpeakerPrograms7.4.2SelectionofHealthcareProfessionalSpeakers7.4.3RequirementsonAttendees7.6.1ProhibitionofGifts7.6.2PromotionalAids7.6.3ItemsofMedicalUtilitytoEnhancetheProvisionofMedicalServicesandPatientCare7.6.4Informational&EducationalItemsthatEnhancePatientCare8.1樣品8.2有效控制和責任落實9.1透明度10.1資助10.2贊助10.2.1獨家贊助10.3對醫(yī)療衛(wèi)生組織的盡職調(diào)查10.4專家咨詢會議11.1范圍11.2參與聲明11.3書面文件11.4活動13.1程序13.2培訓13.3藥品推廣材料的審批8.2ControlandAccouArticle12Supportfor56第十四條對準則的違反，投訴與準Articl則的執(zhí)行動的指南說明77附件三投訴和爭議解決規(guī)程RDPACCodeofPracticeI0102IRDPAC行業(yè)行為準則值觀和原則的文化――最重要的是，商業(yè)行為以及IFPMA成員與醫(yī)療行這些核心理念為IFPMA行為準R&D-basedbiopharmaceuticalmembercompaniesoftheInternationalFederationofPharmaceuticalManufacturersandAssociations(IFPMA)areresponsibleforthediscoveryofmostnewmedicinesandvaccines,whichtheygoontodevelop,promote,sellanddistributeinanethicalmannerandinaccordancewithalltherulesandregulationsformedicinesandhealthcare.Indoingso,theyprovidethehealthcarecommunitywiththelatestscienti?candeducationalinformationtoimproveunderstandingoftreatmentoptionsavailabletopatientsandsupporthigh-qualitypatientcare.IFPMAhastakenanewapproachandmovedfromaCodebasedonrulestoaculturegroundedinintegrity,valuesandprinciples–and,mostimportantly,patienttrust.TheEthosisthefoundationthatshapeshowtheR&Dbasedbiopharmaceuticalindustrysustainstrustbasedonthecorevaluesofcare,fairness,respectandhonestyinlinewithever-changingsociety'sexpectations.TheEthosservestoinstillacultureofethicsandintegrityneededtoguideourbusinessbehavioursandinteractionsbetweenIFPMAmembersandthehealthcarecommunity.TheEthosunderpinstherulesoftheIFPMACodeofPracticeandprovidesaframeworktobehavewithintegritynomatterhowtestingthecircumstances.保護那些使用我們產(chǎn)品的人的安個產(chǎn)品生命周期。通過創(chuàng)新的產(chǎn)品和服務(wù)改善全球健和可靠的安全性的產(chǎn)品。量質(zhì)新創(chuàng)心量質(zhì)新創(chuàng)心信誠任責任信誠任責任支持和尊重公平貿(mào)易慣例和公開競表我們行事的外部第三方的恰當監(jiān)誠實和病患服務(wù)的進步。暢所欲言誠透明暢所欲言誠透明醫(yī)療服務(wù)提立教育隱私教育隱私Protectthesafetyofthosewhouseourproducts–fromtheconductofclinicaltrialsandthroughouttheproductlifecycle.InnovationImproveglobalhealththroughinnovativeproductsandservices,upholdingthehighestethical,scientific,andmedicalstandards.QualityCommittoprovidinghigh-qualityproductsthathaveprovenclinicalefficacyandhaveareliablesafetyprofile.ytilauQnoitavonnIrCTrActwithinytilauQnoitavonnIrCTrActwithinhonestytoim careandbunIse“rtytirFgetytilibatnuoccAusttegrityandnIse“rtytirFgetytilibatnuoccAusttegrityandprovepatientildtrustwithSupportandrespectfairtradepracticesandopencompetition.IntegrityActresponsibly,ethically,andprofession-ally.Donotoffer,promise,provide,oracceptanythingofvalueinordertoinappropriatelyinfluenceadecision,gainanunfairadvantage.AccountabilityBeaccountableforouractionsanddecisions,includingtheappropriateoversightofexternalthirdpartiesthatactonourbehalf.Supportandrespectfairtradepracticesandopencompetition.SpeakingUpActresponsibly,ethically,andprofes-sionally.Donotoffer,promise,provide,oracceptanythingofvalueinordertoinappropriatelyinfluenceadecision,gainanunfairadvantage.TransparencyBeaccountableforouractionsanddecisions,includingtheappropriateoversightofexternalthirdpartiesthatactonourbehalf.SpeakingUpncyHσ“eTsransparethoseweSpeakingUpncyHσ“eTsransparethosewesrespecttheiofhealthcar patients,stakehRe〉μectEducationPrivacyerveRe〉μectEducationPrivacyerveandtondependenceeproviders,andotherolders.Respectallpeopleandembraceacultureofdiversityandinclusion.Protecttheenvironment.Treatanimalsunderourcareresponsibly.PrivacyRespectprivacyrightsandappropriatelymanageandprotectpersonalinforma-tion.EducationSupporttheadvancementofthescientificandmedicaleducationfortheultimatebenefitsofpatients.RDPACCodeofPracticeI05RDPACCodeofPractice06IRDPAC行業(yè)行為準則1.RDPAC準則適用于RDPAC會員公司。非RDPAC會員的制藥公司不在RDPAC準則的規(guī)治范圍之內(nèi)。RDPAC鼓勵非會員公司和其他需要向醫(yī)療衛(wèi)生專業(yè)人士推廣藥品或服務(wù)、或需要與醫(yī)療衛(wèi)生專業(yè)人士、醫(yī)療衛(wèi)生組織、患者組織和患者開展互動交流活動的組織都能遵守與RDPAC準則所規(guī)定藥品推廣及相關(guān)互動交流道德標準相類似有會員公司的雇員，以及代表會員公司執(zhí)2.RDPAC準則不適用于下列活動：TheRDPACCodeofPractice(hereinafteralsothe"RDPACCode")coversmedicalinteractionswithhealthcareprofessionals,healthcareorganizations,patientorganizationsandpatients,andthepromotionofpharmaceuticalproducts.Annotation1-5:1.TheRDPACCodeappliestoRDPAC'smembercompanies.PharmaceuticalcompaniesthatarenotmembersofRDPACfalloutsidethereachoftheRDPACCode.RDPACencouragessuchcompanies–andotherorganizationsmarketinghealthcareproductsorservicestohealthcareprofessionals,orthosehavinginteractionswithhealthcareprofessionals,healthcareorganizations,patientorganizationsandpatients-tofollowethicalstandardsforpromotionandinteractions,similartothosesetforthintheRDPACCode.ItshouldbenotedthoughthatallrelevantmembercompanyemployeesarecoveredbytheCode,aswellassubcontractorsthatcarryouttasksonbehalfofthemembercompany,suchasconsultants,contractedsalesrepresentativesorPRagents.2.ThisCodespecificallydoesnotseektoregulatethefollowingactivities:?直接針對一般公眾所進行的處方藥推廣?直接針對消費者就自我診療藥品進行的非處方藥（OTC）推廣；?Promotionofprescriptiononlypharmaceuticalproductsdirectlytothegeneralpublic(i.e.directtoconsumeradvertising);?Promotionofself-medicationproductsthatareprovided"overthe-counter"(OTC)directlytoconsumerswithoutprescription;RDPACCodeofPracticeI07包括：向商業(yè)性組織進行的藥品推廣和3.不適用RDPAC準則的非推廣類信息可包括為回答針對某個藥品的具體問題而進行的往來函件及其附隨的非推廣類信息資料。有關(guān)會員公司的非推廣類的一般信息（如面向公司投資者及現(xiàn)有的或未來的員工提供的信息），包括財務(wù)數(shù)據(jù)、公司研發(fā)項目介紹、及有關(guān)影響會員公司及其產(chǎn)品的藥事管理最新進展的討論等，也不適用RDPAC準則。4.RDPAC準則適用于向醫(yī)療衛(wèi)生專業(yè)人士進行的非處方藥的推廣，而不適用于向消費5.RDPAC準則適用于向既是有業(yè)務(wù)關(guān)系的商業(yè)性組織同時也是醫(yī)療衛(wèi)生專業(yè)人士的主體進行的藥品推廣和營銷，比如藥劑師自有的藥店。在與此類主體的往來中，會員公司應(yīng)尊重和重視其作為醫(yī)療衛(wèi)生專業(yè)人?Pricingorothertradetermsforthesupplyofpharmaceuticalproducts,includingpromotionandmarketingofpharmaceuticalproductstocommercialcustomers;?Certaintypesofnon-promotionalinformationoractivities;and?Promotionofmedicaldevices.3.Examplesofnon-promotionalinformationthatarenotcoveredbytheCodeincludecorrespondence,possiblyaccompaniedbymaterialofanon-promotionalnature,neededtoansweraspeci?cquestionaboutaparticularmedicinalproductisnotcoveredbytheCode.Non-promotional,generalinformationaboutmembercompanies(suchasinformationdirectedtoinvestorsortocurrent/prospectiveemployees),includingfinancialdata,descriptionsofresearchanddevelopmentprogram,anddiscussionofregulatorydevelopmentsaffectingthemembercompanyanditsproductsisalsonotcoveredbytheCode.4.TheRDPACCodeappliestothepromotionofover-the-counter(OTC)productsdirectedtowardshealthcareprofessionals.However,thepromotionofOTCproductstoconsumersfallsoutsidethescopeofthisCode.5.TheRDPACCodeappliestothepromotionandmarketingofpharmaceuticalproductstocommercialcustomerswhoarealsopracticinghealthcareprofessionals,suchasapharmacistwhooperateshis/herownpractice.Inanydealingswithsuchacustomer,membercompaniesshouldrespectthecustomer'sroleasahealthcareprofessionaland,ifapplicable,complywiththerequirementsoftheRDPACCode.RDPACencouragescompetitionamongmembercompanies,andtheRDPACCodedoesnotrestrainorregulatecommercialtradetermsforthesupplyofpharmaceuticalproducts,tocustomers.08IRDPAC行業(yè)行為準則治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機能并規(guī)定有適應(yīng)癥或者功能主治、用法和用量的物質(zhì)，?“推廣”指由某會員公司通過各種方式――包括互聯(lián)網(wǎng)，以促進其藥品的處方、推薦、供應(yīng)、用于病人或為病人自用等為目的的，針對醫(yī)療衛(wèi)生專業(yè)人士所進行的或組織、或其他任何在其專業(yè)活動中可能開具藥品處方或推薦、采購、供應(yīng)藥域從事任何專業(yè)活動的組織，包括ForthepurposesoftheRDPACCode:?"pharmaceuticalproduct"means,assetforthinArticle2oftheDrugAdministrationLaw,anyarticlesintendedforuseintheprevention,treatmentordiagnosisofhumandiseases,orintendedtoeffectthepurposiveregulationofhumanphysiologicalfunctions,forwhichindicationsormajorfunctions,usageanddosageareprescribed.TheyincludetraditionalChinesemedicines,chemicaldrugs,biologicproducts,etc.?"promotion"meansanyactivityundertaken,organizedorsponsoredbyamembercompanywhichisdirectedathealthcareprofessionalstopromotetheprescription,recommendation,supply,administrationorconsumptionofitspharmaceuticalproduct(s)throughallmethodsofcommunications,includingtheinternet.?"healthcareprofessional"meansanymemberofthemedical,dental,pharmacyornursingprofessionsoranyotherpersonwhointhecourseofhisorherprofessionalactivitiesmayprescribe,recommend,purchase,supply,oradministerapharmaceuticalproduct.?"healthcareorganization"meansanorganizationthatperformsanyprofessionalactivitiesinthehealthcarearea,includingwithoutlimitation:(i)medicalinstitutions;(ii)medicalassociations,physiciansocieties,andhospitalassociations;(iii)industryassociations;and(iv)charitablefoundations.RDPACCodeofPracticeI09士組成的機構(gòu)，或提供醫(yī)療服務(wù)、和/或進行醫(yī)療研究的機構(gòu)，例如專業(yè)學會及協(xié)會或醫(yī)療衛(wèi)生專業(yè)人士提供、從其獲得或與之交流醫(yī)學立或組建、在中國境內(nèi)有實質(zhì)性投公司的研發(fā)類制藥企業(yè)，包括外商投資企業(yè)或其他由前述中國境外研發(fā)類制藥企業(yè)在中國依法設(shè)立的機們的家人和/或護理人員的利益和由醫(yī)療衛(wèi)生專業(yè)人士就藥品或醫(yī)療器械產(chǎn)品或任何醫(yī)學或科學知識向醫(yī)療衛(wèi)生專業(yè)人士參會者發(fā)表演講?"medicalinstitution"meanstypicallyanorganizationthatiscomprisedofhealthcareprofessionalsand/orthatprovideshealthcareorconductshealthcareresearch,e.g.,publichospitals,privatehospitals,andInternethospitals.?"medicalinteraction"or"medicalinteractionprograms"meanseventsthroughwhichmembercompaniesprovide,receiveorexchangemedicaland/orscientificinformationto,fromorwithmedicalinstitutions,academicassociationsorhealthcareprofessionals.?"membercompany"meansanyR&D-basedpharmaceuticalcompanylawfullyestablishedorincorporatedoutsideofChinawithsubstantialinvestmentoroperationalinterestsinChinathatbecameamemberofRDPAC,includingaforeign-investedenterpriseorotherlegalentityregisteredinChinabysuchanoverseasR&D-basedpharmaceuticalcompany.?"patientorganization"meansanot-for-profitinstitutionthatprimarilyrepresentstheinterestsandneedsofpatients,theirfamiliesand/orcaregivers.?"speakerprogram"meansaprogramorganizedbyamembercompanyatwhichahealthcareprofessionalmakesaspeechorpresentationtohealthcareprofessionalattendeesaboutadrugormedicaldeviceproductoranymedicalorscientificknowledge.1010IRDPAC行業(yè)行為準則RDPACCodeofPracticeI112.1醫(yī)學互動交流項目的基本其他利益相關(guān)人士開展醫(yī)學互動交流項目的目的是造?；颊吆吞岣哚t(yī)療水平。醫(yī)學互動交流項目的重點應(yīng)集中在向醫(yī)療衛(wèi)生專業(yè)人士傳達藥品信息、提供科學及教育方面的2.2醫(yī)學互動交流項目的透明度通過適當?shù)毓_與醫(yī)療機構(gòu)、相關(guān)專業(yè)學會及協(xié)會、以及醫(yī)療衛(wèi)生專業(yè)人士的醫(yī)學互動交流項目，逐步提高醫(yī)學互動交流項目的透明度，提升監(jiān)管機構(gòu)以及公眾對會員公司及其使用相關(guān)的材料，無論其性質(zhì)是否屬于推廣，均應(yīng)明示該材料系A(chǔ)rticle2Medicalinteractionprogramsthatmembercompaniesconductinrelationtohealthcareprofessionalsandotherstakeholdersareintendedtobenefitpatientsandtoenhancethepracticeofmedicine.Medicalinteractionprogramsshouldbefocusedoninforminghealthcareprofessionalsaboutmedicines,providingscienti?candeducationalinformationandsupportingmedicalresearchandeducation.Membercompaniesarecommittedtoimprovingthetransparencyofmedicalinteractionprogramsinrelationtomedicalinstitutions,relevantacademicassociationsandhealthcareprofessionalsthroughappropriatedisclosureoftheseprogramsonalegitimatebasis,soastoearnmoretrustfromregulatorybodiesandthegeneralpublicwithregardtomembercompaniesandtheindustryasawhole.Materialrelatingtopharmaceuticalproductsandtheiruses,whetherpromotionalinnatureornot,whichissponsoredbyamembercompany,shouldclearlyindicatebywhomithasbeensponsored.12IRDPAC行業(yè)行為準則學互動交流項目，無論其性質(zhì)是否屬于推廣，均應(yīng)在合法前提下通過日程、條幅、海報或其他方式明示由某會員公司組織或贊助。會員公司不得對其學術(shù)活動作任何形式的隱藏或掩飾。如果會員公司贊助第三方組織的醫(yī)學互動交流項目，則需在主辦方知情并同意的情況下做備案系統(tǒng)，通過合理清晰的分類，準確地記錄有關(guān)醫(yī)學互動交流項目涉及的費用、提供給醫(yī)療衛(wèi)生專業(yè)人士的相關(guān)利益等。費用類別可包括但不限于捐贈、資助、贊助、會議費、講課費、咨詢費等。明確區(qū)分與醫(yī)療衛(wèi)生組織及醫(yī)療衛(wèi)生專業(yè)人士互動產(chǎn)生的費用和內(nèi)部員工費療衛(wèi)生專業(yè)人士的知情同意為前提。尤其針對電子郵件推送、社交媒體等線上互動活動，應(yīng)確保獲得相關(guān)的知情同意并授權(quán)后，再開展相關(guān)Medicalinteractionprogramshostedorsponsoredbymembercompanies,whetherpromotionalinnatureornot,shouldclearlyindicatebywhomithasbeenhostedorsponsored,throughagenda,banner,posterorothereffectivemeasures,underthepremisethatsuchdisclosurewillnotbreachlawsandregulations.Academicactivitiesshouldnotinanywaybeconcealedordisguisedbymembercompanies.Ifamembercompanysponsorsmedicalinteractionprogramsorganizedbyathirdparty,theabovedisclosureshouldbemadesubjecttotheknowledgeandconsentoftheorganizer.Membercompaniesshouldhaveacomprehensiveinternalrecordingandfilingmechanismtoaccuratelydocument,withreasonableandclearclassifications,expendituresandbenefitsprovidedtohealthcareprofessionalsthatareassociatedwithmedicalinteractionprograms.Theclassi?cationsofexpendituresmayinclude,withoutlimitation,donation,grant,sponsorship,meetingexpenses,speakerfees,consultancyfees,etc.Thereshouldbeclearseparationbetweenexpendituresassociatedwithinteractionwithhealthcareorganizationsandhealthcareprofessionalsandthoseforinternalexpensesforemployees.Medicalinteractionprogramsshouldbepremisedontheinformedconsentofhealthcareprofessionals.Inparticular,foronlineinteractionsthroughpushemail,socialmedia,etc.,theinformedconsentandappropriateauthorizationshouldbeobtainedpriortothecommencementofrelevantactivities.RDPACCodeofPracticeI136.當會員公司以資助或其他方式安排將其推廣材料刊登在有相關(guān)資質(zhì)的紙質(zhì)或電子媒體上，這些推廣材料不得有使人誤解其為Annotation6:6.Whereamembercompanyfinancesorotherwisesecuresorarrangesthepublicationofpromotionalmaterialinqualifiedpaperorelectronicmedia,suchpromotionalmaterialmustnotresembleindependenteditorialmatter.14IRDPAC行業(yè)行為準則許可之前，不得從事為在中國上市對科學和醫(yī)學發(fā)展動態(tài)的充分知情權(quán)。它既不限制對藥品的科學信息作充分適當?shù)臏贤?，包括通過專業(yè)的科學或大眾媒體以及在專業(yè)的科學交流會議上公布有關(guān)藥品的科研準則或規(guī)章的要求或號召向利益相Article3NopharmaceuticalproductshouldbepromotedforuseinChinauntiltherequisiteapprovalformarketing(manufacturingorimporting)forsuchusehasbeengivenbytheNMPA.Thisprovisionisnotintendedtopreventtherightofthescienti?ccommunityandthepublictobefullyinformedconcerningscienti?candmedicalprogress.Itisnotintendedtorestrictafullandproperexchangeofscientificinformationconcerningapharmaceuticalproduct,includingappropriatedisseminationofinvestigationalfindingsinscientificorlaycommunicationsmediaandatscientificconferences.Norshoulditrestrictpublicdisclosureofinformationtostockholdersandothersconcerninganypharmaceuticalproduct,asmayberequiredordesirableunderanyapplicablelaws,regulations,codes,orrules.RDPACCodeofPracticeI15注釋7：7.會員公司在藥品獲得上市許可前，或就藥品說明書之外的信息與醫(yī)療衛(wèi)生專業(yè)人士均應(yīng)由會員公司醫(yī)學專業(yè)人員進行或在醫(yī)對藥品獲得上市許可之前信息交流的禁止并不妨礙在遵守各項法律法規(guī)和行政規(guī)章的前提下開展的藥品慈善使用項目。會員公司應(yīng)努力確保有關(guān)藥品慈善使用項目的信息交流活動不演變?yōu)槟硞€未獲得上市許Annotation7:7.Pre-approvaloroff-labelcommunicationwithhealthcareprofessionals,whetherinverbalorwrittenform,shouldbeconductedbyorunderthesupervisionofmedicalexpertsofthemembercompanies.Theprohibitionofpre-approvalcommunicationdoesnotpreventcompassionateuseprogramswhichmustofcoursecomplywithallapplicablelaws,regulationsandadministrativerules.Careshouldbetakentoensurethatcommunicationsforacompassionateuseprogramarenot,ineffect,promotionsforanunlicensedmedicineoruse.部門批準的藥品信息相一致。在遵守藥品信息推廣應(yīng)與中國藥品主管部門批準的藥品信息相一致的要求同時，中國的醫(yī)療衛(wèi)生專業(yè)人士應(yīng)及時獲得在世界其他國家傳播的藥8.會員公司應(yīng)根據(jù)中國藥品行政法律法規(guī)的要求或在其他適當?shù)那闆r下提供與其在其他國家所提供的信息相同的主要產(chǎn)品信息（如：藥品使用禁忌及警示、預(yù)防措施、Article4PromotionshouldnotbeinconsistentwithpharmaceuticalproductinformationapprovedbytheNMPA.RespectingtherequirementthatpromotionshouldbeconsistentwiththelabelandapprovedusesbytheNMPA,Chinesehealthcareprofessionalsshouldhaveaccesstosimilardatatothosebeingauthorizedforcommunicationinothercountriesoftheworld.Annotation8:8.WherenecessaryorappropriatewithinthecontextofChineseregulatoryrequirements,membercompaniesshouldprovidethesamecoreproductinformation(suchascontraindications,warnings,precautions,sideeffectsanddosage)asitprovidesinothercountries.16IRDPAC行業(yè)行為準則Promotionalinformationshouldbeclear,legible,accurate,balanced,fair,andsufficientlycompletetoenabletherecipienttoformhisorherownopinionofthetherapeuticvalueofthepharmaceuticalproductconcerned.Promotionalinformationshouldbebasedonanup-to-dateevaluationofallrelevantevidenceandreflectthatevidenceclearly.Itshouldnotmisleadbydistortion,exaggeration,undueemphasis,omissionorinanyotherway.Everyeffortshouldbemadetoavoidambiguity.Absoluteorall-embracingclaimsshouldbeusedwithcautionandonlywithadequatequalificationandsubstantiation.Descriptionssuchas'safe'and'nosideeffects'shouldgenerallybeavoidedandshouldalwaysbeadequatelyquali?ed.9.對醫(yī)學和科學文獻或?qū)€人交流文件的摘錄應(yīng)忠實于原文（法規(guī)和規(guī)章要求對原文進行改編和修訂的除外，在此情況下應(yīng)清楚顯示所作的改編和修訂），并準確地注明出處。對文獻的摘錄不應(yīng)曲解作者的真Annotation9:9.Quotationsfrommedicalandscienti?cliteratureorfrompersonalcommunicationsshouldbefaithfullyreproduced(exceptwhereadaptationormodificationisrequiredinordertocomplywithanyapplicableregulationsoradministrativerules,inwhichcaseitmustbeclearlystatedthatthequotationhasbeenadaptedand/ormodified)andtheprecisesourcesidenti?ed.Quotationsshouldnotchangeordistorttheintendedmeaningoftheauthororthesignificanceoftheunderlyingworkorstudy.RDPACCodeofPracticeI1710.對兩種不同藥品的比較式表述僅可針對有對應(yīng)性和可比性的內(nèi)容進行，且應(yīng)加以充分的實證。在可以進行比較式表述的情況Promotionshouldbecapableofsubstantiationeitherbyreferencetotheapprovedlabelingorbyscientificevidence.Suchevidenceshouldbemadeavailableonrequesttohealthcareprofessionals.Membercompaniesshoulddealobjectivelywithrequestsforinformationmadeingoodfaithandshouldprovidedatawhichareappropriatetothesourceoftheinquiry.Annotation10:10.Anycomparisonmadebetweendifferentpharmaceuticalproductsshouldbebasedonrelevantandcomparableaspectsoftheproductsandbecapableofsubstantiation.Comparativeclaims,wherepossible,shouldnotbemisleading.18IRDPAC行業(yè)行為準則(a)藥品名稱（通常為藥品的商品(b)藥物活性成份（應(yīng)盡可能地使用(c)制藥公司或藥品代理公司的名稱(e)處方信息概要，包括已經(jīng)批準的一項或多項適應(yīng)癥、用法用量，以及對禁忌癥提示和副作用的簡Article5SubjecttoadditionalrequirementsundertheChineselawsandregulations,allprintedpromotionalmaterialsmustbelegibleandinclude:(a)thenameoftheproduct(normallythebrandname);(b)theactiveingredients,usingapprovednameswheretheyexist;(c)thenameandaddressofthepharmaceuticalcompanyoritsagentresponsibleformarketingtheproduct;(d)dateofproductionofthematerial;(e)"abbreviatedprescribinginformation"whichshouldincludeanapprovedindicationorindicationsforusetogetherwiththedosageandmethodofuse;andasuccinctstatementofthecontraindicationsprecautionsandsideeffects.RDPACCodeofPracticeI19注釋11：11.科學或醫(yī)學文章的翻印本在單獨使用時不構(gòu)成“藥品推廣材料”，因其非由制藥公司制作；但如果將它們連同由制藥公司制作的其他文件一起發(fā)送到醫(yī)療衛(wèi)生專業(yè)人士手中，則這些翻印本就轉(zhuǎn)變?yōu)樗幤吠茝V材料。一旦某個推廣材料中提及或者包含了科學或醫(yī)學的論文或研究報告，或這些論文報告與推廣材料一起被發(fā)送給相對人時，推廣人均應(yīng)對論文或報告的出處作清并被包含在推廣材料中，或與推廣材料一起被發(fā)送給相對人的非文字信息（包括圖表、示圖、照片或者表格等）的翻印，推廣人均須清楚地注明出處，且翻印應(yīng)忠實Annotation11:11.Reprintsofscienti?candmedicalarticles,whenusedasstandalonedocuments,arenotdevelopedbypharmaceuticalcompaniesandassuchcannotbeconsideredaspromotionalmaterials.If,however,theyareproactivelypresentedtoahealthcareprofessionaltogether,withother,company-originateddocuments,theythenbecomepromotionalmaterials.Inallcases,wherepromotionrefersto,includes,orispresentedtogetherwithscienti?cormedicalarticlesorstudies,clearreferencesshouldbeprovided.Anyreprintofartwork(includinggraphs,illustrations,photographsortables)takenfromarticlesorstudiesandincludedorpresentedwithpromotionalmaterialsshouldclearlyindicatethesourceoftheartworkandbefaithfullyreproduced.20IRDPAC行業(yè)行為準則(a)制藥公司的名稱以及推廣所針對(b)推廣內(nèi)容應(yīng)適合于其所針對的受(c)其制作（內(nèi)容、鏈接等）對其所(d)針對中國市場的信息應(yīng)符合中國Article6Thesamerequirementsshouldapplytoelectronicpromotionalmaterialsasapplytoprintedmaterials.Specifically,inthecaseofpharmaceuticalproductrelatedwebsites:(a)theidentityofthepharmaceuticalcompanyandoftheintendedaudienceshouldbereadilyapparent;(b)thecontentshouldbeappropriatefortheintendedaudience;(c)thepresentation(content,links,etc.)shouldbeappropriateandapparenttotheintendedaudience;and(d)informationspeci?ctoChinashouldcomplywithalltheChineselawsandregulations.RDPACCodeofPracticeI21生專業(yè)人士赴其本國以外參加醫(yī)學互動交流項目（包括支持個人參加除非滿足IFPMA行為準則（2019）以及IFPMA關(guān)于贊助互動交流活動的指南說明（以下稱“IFPMA贊助12.會員公司只可在理由充分的情況下組織醫(yī)療衛(wèi)生專業(yè)人士赴其本國以外參加醫(yī)學互(a)有關(guān)活動所邀請的大部分醫(yī)療衛(wèi)生專業(yè)人士都來自其本國以外，且出于會議行程及安全的考慮，在境外舉辦該活動更Article77.1.1MedicalInteractionProgramsInvolvingNomembercompanymayorganizeorsponsoramedicalinteractionprogramforhealthcareprofessionals(includingsupportingindividualstoattendsuchamedicalinteractionprogramasdescribedinArticle7.2)thattakesplaceoutsideoftheirhomecountryunlesstheprinciplesandrequirementssetbytheIFPMACodeofPractice2019,aswellastheIFPMANoteforGuidanceonSponsorshipofEventsandMeetings(hereinafter"IFPMAGuidanceonSponsorship")aresatis?ed.Annotation12:12.Amembercompanycanonlyorganizemedicalinteractionprogramsinvolvingforeigntravelifitisjusti?ed,i.e.:(a)Asignificantproportionoftheinvitedhealthcareprofessionalsarefromoutsideoftheirhomecountry,anditmakesgreaterlogisticalorsecuritysensetoholdtheeventinsuchothercountry;or22IRDPAC行業(yè)行為準則(b)作為有關(guān)活動主題的相關(guān)資源或?qū)＜揖鵕DPAC準則所指的“本國”是指相關(guān)此外，會員公司在評價醫(yī)學互動交流項目地點或場所的適當性時，或者在決定是否贊助醫(yī)學會等第三方組織的醫(yī)學互動交流項目時，或者在審查會議官方宣傳材料和網(wǎng)站時，應(yīng)按照IFPMA贊助指南所提供的標準進行評價。該指南的具體內(nèi)容請見本準則附件一，或參考在IFPMA官網(wǎng)發(fā)布/更新的該指南文件（https://www./resources/publications/）。7.1.2醫(yī)學互動交流項目中的藥品推座談會上通過展臺或直接分發(fā)給參會者的方式推廣某個/些尚未在會議所在國獲得上市許可、或雖獲得上市許可但許可的內(nèi)容和條件與其他國家有所不同的藥品，但還須同時?會議所在國法律允許進行此種推?會議本身應(yīng)當是真正意義上的國應(yīng)來自會議所在國以外的其他國(b)Therelevantresourceorexpertisethatistheobjectorsubjectmatteroftheeventislocatedoutsideofthehealthcareprofessional'shomecountry.UndertheRDPACCode,thehomecountryofahealthcareprofessionalisthecountryinwhichhe/shepractices.Also,membercompaniesshouldrefertotheCriteriasetbytheIFPMAGuidanceonSponsorshipwhenassessingtheappropriatenessoftheLocationofamedicalinteractionprogram,ortheVenueofamedicalinteractionprogram,orwhendecidingwhethertosupportamedicalinteractionprogramorganizedbyathirdpartysuchasamedicalsociety,orwhenreviewingtheOfficialmeetingmaterialsandwebsitesofamedicalinteractionprogram.FordetailsseeIFPMAGuidanceonSponsorshipinAppendixIofthisCode,orrefertotheGuidancepostedandupdatedonIFPMAWebsite（/resources/publications/）.7.1.2PromotionalInformationatMedicalPromotionalinformationwhichappearsonexhibitionstandsorisdistributedtoparticipantsatinternationalscientificcongressesandsymposiamayrefertopharmaceuticalproductswhicharenotregisteredinthecountrywherethemeetingtakesplace,orwhichareregisteredunderdifferentconditions,providedthatthefollowingconditionsareobserved:?Hostcountryregulationsshouldpermitsuchanarrangement;?Themeetingshouldbeatrulyinternational,scientificmeetingwithasignificantproportionofthespeakersandattendeesfromcountriesotherthanthecountrywherethemeetingtakesplace;RDPACCodeofPracticeI23?尚未在會議所在國注冊的藥品推廣材料（不包括本準則第7.6.2中?如藥品推廣材料中包含在會議所適當且以有助于實現(xiàn)其科學、教育及會議本身的目的為宗旨。會員公司應(yīng)避免選擇名勝或鋪張奢侈的地點舉辦醫(yī)學互動交流項目。在選擇醫(yī)學互動交流項目的適當?shù)攸c時還應(yīng)遵守本準則第7條及IFPMA贊助?Promotionalmaterial(excludingpromotionalaidsasdescribedinArticle7.6.2)forapharmaceuticalproductnotregisteredinthecountryofthemeetingshouldbeaccompaniedbyasuitablestatementindicatingthecountriesinwhichtheproductisregisteredandmakeclearthatsuchproductisnotavailablelocally;?Promotionalmaterialwhichreferstotheprescribinginformation(indications,warnings,etc.)authorizedinacountryorcountriesotherthanthatinwhichthemeetingtakesplacebutwheretheproductisalsoregistered,shouldbeaccompaniedbyanexplanatorystatementindicatingthatregistrationconditionsdifferinternationally.Allmedicalinteractionprogramsmustbeheldinanappropriatevenuethatisconducivetothescientificoreducationalobjectivesandthepurposeofthemedicalinteractionprogram.Membercompaniesmustavoidusingrenownedorextravagantvenues.TheadditionalrequirementssetforthinArticle7ofthisCode,aswellastheIFPMAGuidanceonSponsorshipalsoapplyaccordingly.24IRDPAC行業(yè)行為準則注釋13：13.會員公司應(yīng)謹慎選擇會議的舉辦地，以盡量減少參會者的旅行，并避免造成鋪張奢侈的公眾形象，避免選擇與奢侈的娛樂活滑雪、高爾夫、賭博、郵輪等。IFPMA贊助指南所提供的其他原則和要求詳見本準則附件一，或參考在IFPMA官網(wǎng)發(fā)布/更新的該指南文件(/resources/p