RDPAC行業(yè)行為準(zhǔn)則 2022年修訂版

目錄TableofContents1.1范圍11第二條醫(yī)學(xué)互動(dòng)交流活動(dòng)的基本原則2.1醫(yī)學(xué)互動(dòng)交流活動(dòng)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(biāo)明的適用范圍之4.1藥品信息的一致性4.2準(zhǔn)確和不誤導(dǎo)4.3實(shí)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(zhuān)業(yè)人士的醫(yī)學(xué)7.1醫(yī)學(xué)互動(dòng)交流項(xiàng)目7.1.1涉及出國(guó)的醫(yī)學(xué)互動(dòng)交流項(xiàng)目7.1.2醫(yī)學(xué)互動(dòng)交流項(xiàng)目中的藥品推7.1.3適當(dāng)?shù)牡攸c(diǎn)/住宿7.1.4限制7.1.5娛樂(lè)7.2支持7.2.1直接支持個(gè)人醫(yī)療衛(wèi)生專(zhuān)業(yè)人士7.3服務(wù)費(fèi)7.4講者項(xiàng)目7.4.1講者項(xiàng)目的目的7.4.2選擇醫(yī)療衛(wèi)生專(zhuān)業(yè)人士講者7.4.3對(duì)參會(huì)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(zé)任落實(shí)9.1透明度10.1資助10.2贊助10.2.1獨(dú)家贊助10.3對(duì)醫(yī)療衛(wèi)生組織的盡職調(diào)查10.4專(zhuān)家咨詢會(huì)議11.1范圍11.2參與聲明11.3書(shū)面文件11.4活動(dòng)13.1程序13.2培訓(xùn)13.3藥品推廣材料的審批8.2ControlandAccouArticle12Supportfor56第十四條對(duì)準(zhǔn)則的違反，投訴與準(zhǔn)Articl則的執(zhí)行動(dòng)的指南說(shuō)明77附件三投訴和爭(zhēng)議解決規(guī)程RDPACCodeofPracticeI0102IRDPAC行業(yè)行為準(zhǔn)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(zhǔn)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(hù)那些使用我們產(chǎn)品的人的安個(gè)產(chǎn)品生命周期。通過(guò)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(chéng)任責(zé)任信誠(chéng)任責(zé)任支持和尊重公平貿(mào)易慣例和公開(kāi)競(jìng)表我們行事的外部第三方的恰當(dāng)監(jiān)誠(chéng)實(shí)和病患服務(wù)的進(jìn)步。暢所欲言誠(chéng)透明暢所欲言誠(chéng)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(zhǔn)則1.RDPAC準(zhǔn)則適用于RDPAC會(huì)員公司。非RDPAC會(huì)員的制藥公司不在RDPAC準(zhǔn)則的規(guī)治范圍之內(nèi)。RDPAC鼓勵(lì)非會(huì)員公司和其他需要向醫(yī)療衛(wèi)生專(zhuān)業(yè)人士推廣藥品或服務(wù)、或需要與醫(yī)療衛(wèi)生專(zhuān)業(yè)人士、醫(yī)療衛(wèi)生組織、患者組織和患者開(kāi)展互動(dòng)交流活動(dòng)的組織都能遵守與RDPAC準(zhǔn)則所規(guī)定藥品推廣及相關(guān)互動(dòng)交流道德標(biāo)準(zhǔn)相類(lèi)似有會(huì)員公司的雇員，以及代表會(huì)員公司執(zhí)2.RDPAC準(zhǔn)則不適用于下列活動(dòng)：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(duì)一般公眾所進(jìn)行的處方藥推廣?直接針對(duì)消費(fèi)者就自我診療藥品進(jìn)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(jìn)行的藥品推廣和3.不適用RDPAC準(zhǔn)則的非推廣類(lèi)信息可包括為回答針對(duì)某個(gè)藥品的具體問(wèn)題而進(jìn)行的往來(lái)函件及其附隨的非推廣類(lèi)信息資料。有關(guān)會(huì)員公司的非推廣類(lèi)的一般信息（如面向公司投資者及現(xiàn)有的或未來(lái)的員工提供的信息），包括財(cái)務(wù)數(shù)據(jù)、公司研發(fā)項(xiàng)目介紹、及有關(guān)影響會(huì)員公司及其產(chǎn)品的藥事管理最新進(jìn)展的討論等，也不適用RDPAC準(zhǔn)則。4.RDPAC準(zhǔn)則適用于向醫(yī)療衛(wèi)生專(zhuān)業(yè)人士進(jìn)行的非處方藥的推廣，而不適用于向消費(fèi)5.RDPAC準(zhǔn)則適用于向既是有業(yè)務(wù)關(guān)系的商業(yè)性組織同時(shí)也是醫(yī)療衛(wèi)生專(zhuān)業(yè)人士的主體進(jìn)行的藥品推廣和營(yíng)銷(xiāo)，比如藥劑師自有的藥店。在與此類(lèi)主體的往來(lái)中，會(huì)員公司應(yīng)尊重和重視其作為醫(yī)療衛(wèi)生專(zhuān)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(zhǔn)則治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機(jī)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(huì)員公司通過(guò)各種方式――包括互聯(lián)網(wǎng)，以促進(jìn)其藥品的處方、推薦、供應(yīng)、用于病人或?yàn)椴∪俗杂玫葹槟康牡?，針?duì)醫(yī)療衛(wèi)生專(zhuān)業(yè)人士所進(jìn)行的或組織、或其他任何在其專(zhuān)業(yè)活動(dòng)中可能開(kāi)具藥品處方或推薦、采購(gòu)、供應(yīng)藥域從事任何專(zhuān)業(yè)活動(dòng)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(jī)構(gòu)，或提供醫(yī)療服務(wù)、和/或進(jìn)行醫(yī)療研究的機(jī)構(gòu)，例如專(zhuān)業(yè)學(xué)會(huì)及協(xié)會(huì)或醫(yī)療衛(wèi)生專(zhuān)業(yè)人士提供、從其獲得或與之交流醫(yī)學(xué)立或組建、在中國(guó)境內(nèi)有實(shí)質(zhì)性投公司的研發(fā)類(lèi)制藥企業(yè)，包括外商投資企業(yè)或其他由前述中國(guó)境外研發(fā)類(lèi)制藥企業(yè)在中國(guó)依法設(shè)立的機(jī)們的家人和/或護(hù)理人員的利益和由醫(yī)療衛(wèi)生專(zhuān)業(yè)人士就藥品或醫(yī)療器械產(chǎn)品或任何醫(yī)學(xué)或科學(xué)知識(shí)向醫(yī)療衛(wèi)生專(zhuān)業(yè)人士參會(huì)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(zhǔn)則RDPACCodeofPracticeI112.1醫(yī)學(xué)互動(dòng)交流項(xiàng)目的基本其他利益相關(guān)人士開(kāi)展醫(yī)學(xué)互動(dòng)交流項(xiàng)目的目的是造?；颊吆吞岣哚t(yī)療水平。醫(yī)學(xué)互動(dòng)交流項(xiàng)目的重點(diǎn)應(yīng)集中在向醫(yī)療衛(wèi)生專(zhuān)業(yè)人士傳達(dá)藥品信息、提供科學(xué)及教育方面的2.2醫(yī)學(xué)互動(dòng)交流項(xiàng)目的透明度通過(guò)適當(dāng)?shù)毓_(kāi)與醫(yī)療機(jī)構(gòu)、相關(guān)專(zhuān)業(yè)學(xué)會(huì)及協(xié)會(huì)、以及醫(yī)療衛(wèi)生專(zhuān)業(yè)人士的醫(yī)學(xué)互動(dòng)交流項(xiàng)目，逐步提高醫(yī)學(xué)互動(dòng)交流項(xiàng)目的透明度，提升監(jiān)管機(jī)構(gòu)以及公眾對(duì)會(huì)員公司及其使用相關(guān)的材料，無(wú)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(zhǔn)則學(xué)互動(dòng)交流項(xiàng)目，無(wú)論其性質(zhì)是否屬于推廣，均應(yīng)在合法前提下通過(guò)日程、條幅、海報(bào)或其他方式明示由某會(huì)員公司組織或贊助。會(huì)員公司不得對(duì)其學(xué)術(shù)活動(dòng)作任何形式的隱藏或掩飾。如果會(huì)員公司贊助第三方組織的醫(yī)學(xué)互動(dòng)交流項(xiàng)目，則需在主辦方知情并同意的情況下做備案系統(tǒng)，通過(guò)合理清晰的分類(lèi)，準(zhǔn)確地記錄有關(guān)醫(yī)學(xué)互動(dòng)交流項(xiàng)目涉及的費(fèi)用、提供給醫(yī)療衛(wèi)生專(zhuān)業(yè)人士的相關(guān)利益等。費(fèi)用類(lèi)別可包括但不限于捐贈(zèng)、資助、贊助、會(huì)議費(fèi)、講課費(fèi)、咨詢費(fèi)等。明確區(qū)分與醫(yī)療衛(wèi)生組織及醫(yī)療衛(wèi)生專(zhuān)業(yè)人士互動(dòng)產(chǎn)生的費(fèi)用和內(nèi)部員工費(fèi)療衛(wèi)生專(zhuān)業(yè)人士的知情同意為前提。尤其針對(duì)電子郵件推送、社交媒體等線上互動(dòng)活動(dòng)，應(yīng)確保獲得相關(guān)的知情同意并授權(quán)后，再開(kāi)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(dāng)會(huì)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(zhǔn)則許可之前，不得從事為在中國(guó)上市對(duì)科學(xué)和醫(yī)學(xué)發(fā)展動(dòng)態(tài)的充分知情權(quán)。它既不限制對(duì)藥品的科學(xué)信息作充分適當(dāng)?shù)臏贤?，包括通過(guò)專(zhuān)業(yè)的科學(xué)或大眾媒體以及在專(zhuān)業(yè)的科學(xué)交流會(huì)議上公布有關(guān)藥品的科研準(zhǔn)則或規(guī)章的要求或號(hào)召向利益相Article3NopharmaceuticalproductshouldbepromotedforuseinChinauntiltherequisiteapprovalformarketing(manufacturingorimporting)forsuchusehasbeengivenbytheNMPA.Thisprovisionisnotintendedtopreventtherightofthescienti?ccommunityandthepublictobefullyinformedconcerningscienti?candmedicalprogress.Itisnotintendedtorestrictafullandproperexchangeofscientificinformationconcerningapharmaceuticalproduct,includingappropriatedisseminationofinvestigationalfindingsinscientificorlaycommunicationsmediaandatscientificconferences.Norshoulditrestrictpublicdisclosureofinformationtostockholdersandothersconcerninganypharmaceuticalproduct,asmayberequiredordesirableunderanyapplicablelaws,regulations,codes,orrules.RDPACCodeofPracticeI15注釋7：7.會(huì)員公司在藥品獲得上市許可前，或就藥品說(shuō)明書(shū)之外的信息與醫(yī)療衛(wèi)生專(zhuān)業(yè)人士均應(yīng)由會(huì)員公司醫(yī)學(xué)專(zhuān)業(yè)人員進(jìn)行或在醫(yī)對(duì)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(xiàng)法律法規(guī)和行政規(guī)章的前提下開(kāi)展的藥品慈善使用項(xiàng)目。會(huì)員公司應(yīng)努力確保有關(guān)藥品慈善使用項(xiàng)目的信息交流活動(dòng)不演變?yōu)槟硞€(gè)未獲得上市許Annotation7:7.Pre-approvaloroff-labelcommunicationwithhealthcareprofessionals,whetherinverbalorwrittenform,shouldbeconductedbyorunderthesupervisionofmedicalexpertsofthemembercompanies.Theprohibitionofpre-approvalcommunicationdoesnotpreventcompassionateuseprogramswhichmustofcoursecomplywithallapplicablelaws,regulationsandadministrativerules.Careshouldbetakentoensurethatcommunicationsforacompassionateuseprogramarenot,ineffect,promotionsforanunlicensedmedicineoruse.部門(mén)批準(zhǔn)的藥品信息相一致。在遵守藥品信息推廣應(yīng)與中國(guó)藥品主管部門(mén)批準(zhǔn)的藥品信息相一致的要求同時(shí)，中國(guó)的醫(yī)療衛(wèi)生專(zhuān)業(yè)人士應(yīng)及時(shí)獲得在世界其他國(guó)家傳播的藥8.會(huì)員公司應(yīng)根據(jù)中國(guó)藥品行政法律法規(guī)的要求或在其他適當(dāng)?shù)那闆r下提供與其在其他國(guó)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(zhǔn)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(duì)醫(yī)學(xué)和科學(xué)文獻(xiàn)或?qū)€(gè)人交流文件的摘錄應(yīng)忠實(shí)于原文（法規(guī)和規(guī)章要求對(duì)原文進(jìn)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(zhǔn)確地注明出處。對(duì)文獻(xiàn)的摘錄不應(yīng)曲解作者的真Annotation9:9.Quotationsfrommedicalandscienti?cliteratureorfrompersonalcommunicationsshouldbefaithfullyreproduced(exceptwhereadaptationormodificationisrequiredinordertocomplywithanyapplicableregulationsoradministrativerules,inwhichcaseitmustbeclearlystatedthatthequotationhasbeenadaptedand/ormodified)andtheprecisesourcesidenti?ed.Quotationsshouldnotchangeordistorttheintendedmeaningoftheauthororthesignificanceoftheunderlyingworkorstudy.RDPACCodeofPracticeI1710.對(duì)兩種不同藥品的比較式表述僅可針對(duì)有對(duì)應(yīng)性和可比性的內(nèi)容進(jìn)行，且應(yīng)加以充分的實(shí)證。在可以進(jìn)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(zhǔn)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(zhǔn)的一項(xiàng)或多項(xiàng)適應(yīng)癥、用法用量，以及對(duì)禁忌癥提示和副作用的簡(jiǎn)Article5SubjecttoadditionalrequirementsundertheChineselawsandregulations,allprintedpromotionalmaterialsmustbelegibleandinclude:(a)thenameoftheproduct(normallythebrandname);(b)theactiveingredients,usingapprovednameswheretheyexist;(c)thenameandaddressofthepharmaceuticalcompanyoritsagentresponsibleformarketingtheproduct;(d)dateofproductionofthematerial;(e)"abbreviatedprescribinginformation"whichshouldincludeanapprovedindicationorindicationsforusetogetherwiththedosageandmethodofuse;andasuccinctstatementofthecontraindicationsprecautionsandsideeffects.RDPACCodeofPracticeI19注釋11：11.科學(xué)或醫(yī)學(xué)文章的翻印本在單獨(dú)使用時(shí)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(zhuān)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(gè)推廣材料中提及或者包含了科學(xué)或醫(yī)學(xué)的論文或研究報(bào)告，或這些論文報(bào)告與推廣材料一起被發(fā)送給相對(duì)人時(shí)，推廣人均應(yīng)對(duì)論文或報(bào)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(duì)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(shí)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(zhǔn)則(a)制藥公司的名稱以及推廣所針對(duì)(b)推廣內(nèi)容應(yīng)適合于其所針對(duì)的受(c)其制作（內(nèi)容、鏈接等）對(duì)其所(d)針對(duì)中國(guó)市場(chǎng)的信息應(yīng)符合中國(guó)Article6Thesamerequirementsshouldapplytoelectronicpromotionalmaterialsasapplytoprintedmaterials.Specifically,inthecaseofpharmaceuticalproductrelatedwebsites:(a)theidentityofthepharmaceuticalcompanyandoftheintendedaudienceshouldbereadilyapparent;(b)thecontentshouldbeappropriatefortheintendedaudience;(c)thepresentation(content,links,etc.)shouldbeappropriateandapparenttotheintendedaudience;and(d)informationspeci?ctoChinashouldcomplywithalltheChineselawsandregulations.RDPACCodeofPracticeI21生專(zhuān)業(yè)人士赴其本國(guó)以外參加醫(yī)學(xué)互動(dòng)交流項(xiàng)目（包括支持個(gè)人參加除非滿足IFPMA行為準(zhǔn)則（2019）以及IFPMA關(guān)于贊助互動(dòng)交流活動(dòng)的指南說(shuō)明（以下稱“IFPMA贊助12.會(huì)員公司只可在理由充分的情況下組織醫(yī)療衛(wèi)生專(zhuān)業(yè)人士赴其本國(guó)以外參加醫(yī)學(xué)互(a)有關(guān)活動(dòng)所邀請(qǐng)的大部分醫(yī)療衛(wèi)生專(zhuān)業(yè)人士都來(lái)自其本國(guó)以外，且出于會(huì)議行程及安全的考慮，在境外舉辦該活動(dòng)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(zhǔn)則(b)作為有關(guān)活動(dòng)主題的相關(guān)資源或?qū)＜揖鵕DPAC準(zhǔn)則所指的“本國(guó)”是指相關(guān)此外，會(huì)員公司在評(píng)價(jià)醫(yī)學(xué)互動(dòng)交流項(xiàng)目地點(diǎn)或場(chǎng)所的適當(dāng)性時(shí)，或者在決定是否贊助醫(yī)學(xué)會(huì)等第三方組織的醫(yī)學(xué)互動(dòng)交流項(xiàng)目時(shí)，或者在審查會(huì)議官方宣傳材料和網(wǎng)站時(shí)，應(yīng)按照IFPMA贊助指南所提供的標(biāo)準(zhǔn)進(jìn)行評(píng)價(jià)。該指南的具體內(nèi)容請(qǐng)見(jiàn)本準(zhǔn)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(xué)互動(dòng)交流項(xiàng)目中的藥品推座談會(huì)上通過(guò)展臺(tái)或直接分發(fā)給參會(huì)者的方式推廣某個(gè)/些尚未在會(huì)議所在國(guó)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(guó)家有所不同的藥品，但還須同時(shí)?會(huì)議所在國(guó)法律允許進(jìn)行此種推?會(huì)議本身應(yīng)當(dāng)是真正意義上的國(guó)應(yīng)來(lái)自會(huì)議所在國(guó)以外的其他國(guó)(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(huì)議所在國(guó)注冊(cè)的藥品推廣材料（不包括本準(zhǔn)則第7.6.2中?如藥品推廣材料中包含在會(huì)議所適當(dāng)且以有助于實(shí)現(xiàn)其科學(xué)、教育及會(huì)議本身的目的為宗旨。會(huì)員公司應(yīng)避免選擇名勝或鋪張奢侈的地點(diǎn)舉辦醫(yī)學(xué)互動(dòng)交流項(xiàng)目。在選擇醫(yī)學(xué)互動(dòng)交流項(xiàng)目的適當(dāng)?shù)攸c(diǎn)時(shí)還應(yīng)遵守本準(zhǔn)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(zhǔn)則注釋13：13.會(huì)員公司應(yīng)謹(jǐn)慎選擇會(huì)議的舉辦地，以盡量減少參會(huì)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(lè)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(jiàn)本準(zhǔn)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