行业报告环球律师事务所全球法律指南：生命科学2023之中国篇英_市场营销策划_重点报告20.docx

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1、Cambcesw%kt队CHAMBERSG1OBA1PRACTICEGUIDES1ifeSciences2023Definitiveg1oba11awguidesofferingcomparativeana1ysisfromtop-ranked1awyersChina:1aw&PracticeA1anZhou5CocoFan,StephanieWangandXuchunHuangG1oba11awOfficeCHINA1awandPracticeContributedby:A1anZhou,CoFan,StephanieWangandXucunHuangG1oba11awOfficeConte

2、nts1. 1ifeSciencesRegu1atoryFrameworkp.61.1 1egis1ationandRegu1ationforPharmaceutica1sandMedica1Devicesp.61.2 Cha11engingDecisionsofRegu1atoryBodiesThatEnforcePharmaceutica1sandMedica1DevicesRegu1ationp.71.3 DifferentCategoriesofPharmaceutica1sandMedica1Devicesp.72. C1inica1Tria1sp.72.1 Regu1ationof

3、C1inica1Tria1sp.72.2 ProcedureforSecuringAuthorisationtoUndertakeaC1inica1Tria1p.82.3 Pub1icAvai1abi1ityoftheConductofaC1inica1Tria1p.82.4 RestrictiononUsingOn1ineToo1stoSupportC1inica1Tria1sp.92.5 UseofDataResu1tingFromtheC1inica1Tria1sp.92.6 DatabasesContainingPersona1orSensitiveDatap.93. Marketin

4、gAuthorisationsforPharmaceutica1orMedica1Devicesp.93.1 ProductC1assification:Pharmaceutica1orMedica1Devicesp.93.2 GrantingaMarketingAuthorisationforBio1ogicMedicina1Productsp.103.3 PeriodofVa1idityforMarketingAuthorisationforPharmaceutica1orMedica1Devicesp.103.4 ProcedureforObtainingaMarketingAuthor

5、isationforPharmaceutica1andMedica1Devicesp.103.5 AccesstoPharmaceutica1andMedica1DevicesWithoutMarketingAuthorisationsp.123.6 MarketingAuthorisationsforPharmaceutica1andMedica1Devices:OngoingOb1igationsp.123.7 Third-PartyAccesstoPendingApp1icationsforMarketingAuthorisationsforPharmaceutica1andMedica

6、1Devicesp.133.8 Ru1esAgainstI11ega1Medicinesand/orMedica1Devicesp.133.9 BorderMeasurestoTack1e(CounterfeitPharmaceutica1andMedica1Devicesp.134. ManufacturingofPharmaceutica1andMedica1Devicesp.144.1 RequirementforAuthorisationforManufacturingP1antsofPharmaceutica1andMedica1Devicesp.145. Distributiono

7、fPharmaceutica1andMedica1Devicesp.155.1 Who1esa1eofPharmaceutica1andMedica1Devicesp.155.2 DifferentC1assificationsApp1icab1etoPharmaceutica1sp.156. ImportationandExportationofPharmaceutica1sandMedica1Devicesp.156.1 Governing1awfortheImportationandExportationofPharmautica1DevicesandRe1evantEnforcemen

8、tBodiesp.156.2 ImporterofRecordofPharmaceutica1andMedica1Devicesp.166.3 PriorAuthorisationsfortheImportationofPharmaceutica1sandMedica1Devicesp.16CHINACONTENTS6.4 No-tariffRegu1ationsandRestrictionsImposedUponImportationp.166.5 TradeB1sandFreeTradeAgreementsp.177. Pharmaceutica1andMedica1DevicePrici

9、ngandReimbursementp.177.1 PriceContro1forPharmaceutica1sandMedica1Devicesp.177.2 Price1eve1sofPharmaceutica1orMedica1Devicesp.187.3 Pharmaceutica1sandMedica1Devices:ReimbursementFromPub1icFundsp.187.4 Cost-BenefitAna1ysesforPharmaceutica1sandMedica1Devicesp.187.5 Regu1ationofPrescriptionsandDispensi

10、ngbyPharmaciesp.198. Digita1Hea1thcarep.198.1 Ru1esforMedica1Appsp.198.2 Ru1esforTe1emedicinep.208.3 Promotingand/orAdvertisingonanOn1ineP1atformp.208.4 E1ectronicPrescriptionsp.208.5 On1ineSa1esofMedicinesandMedica1Devicesp.218.6 E1ectronicHea1thRecordsp.219. PatentsRe1atingtoPharmaceutica1sandMedi

11、ca1Devices.229.1 1awsApp1icab1etoPatentsforPharmaceutica1andMedica1Devicesp.229.2 SecondandSubsequentMedica1Usesp.239.3 PatentTermExtensionforPharmaceutica1sp.239.4 Pharmaceutica1orMedica1DevicePatentInfringementp.239.5 DefencestoPatentInfringementinRe1ationtoPharmaceutica1sandMedica1Devicesp.249.6

12、ProceedingsforPatentInfringementp.259.7 ProceduresAvai1ab1etoaGenericEntrantp.2610. IPOtherThanPatents.2610.1 CounterfeitPharmaceutica1sandMedica1Devicesp.2610.2 RestrictionsonTradeMarksUsedforPharmaceutica1sandMedica1Devicesp.2710.3 IPProtectionforTradeDressorDesignofPharmaceutica1sandMedica1Device

13、sp.2710.4 DataExc1usivityforPharmaceutica1sandMedica1Devicesp.2711. COVID-19and1ifeSciencesp.2711.1 Specia1Regu1ationforCommercia1isationorDistributionofMedicinesandMedica1Devicesp.2711.2 Specia1MeasuresRe1atingtoC1inica1Tria1sp.2711.3 EmergencyApprova1sofPharmaceutica1sandMedica1Devicesp.2811.4 F1e

14、xibi1ityinManufacturingCertificationasaResu1tofCOVID-19p.2811.5 ImporVExportRestrictionsorF1exibi1itiesasaResu1tofCOVID-19p.2811.6 DriversforDigita1Hea1thInnovationDuetoCOVID-19p.2811.7 Compu1sory1icensingofIPRightsforCOVID-19-Re1atedTreatmentsp.2911.8 1iabi1ityExemptionsforCOVID-19TreatmentsorVaine

15、sp.2911.9 RequisitionorConversionofManufacturingSitesp.2911.10 ChangestotheSystemofPub1icProcurementofMedicinesandMedica1Devicesp.29Contributedby:A1anZhou,CoFan,StephanieWangandXuchunHuang,G1oba11awOfficeG1oba11awOffice(G1O)hasbecomeoneofthe1argest,1eadingChinese1awfirms,withmorethan5001awyerspractisinginitsBeijing,Shanghai,ShenzhenandChengduoffices.Its1ifesciencesandhea1thcarepracticegroupwasoneofthefirstinChinaandprovides“onestop1ega1servicesforeveryareaoftheindustry,inc1udingM&A,investmentandfunding,1icenceinandout,dai1yoperation,IPprotection,andadviceoncomp1ian