全球法律指南：生命科学2024（英）-30页

CHAMBERSGLOBALPRACTICEGUIDESLifeSciences2024Definitivegloballawguidesofferingcomparativeanalysisfromtop-rankedlawyersChina:Law&PracticeAlanZhou,CocoFan,StephanieWangandKellyCaoGlobalLawOfficeCHINALawandPracticeContributedby:AlanZhou,CocoFan,StephanieWangandKellyCaoGlobalLawOfficeContents1.LifeSciencesRegulatoryFrameworkp.61.1LegislationandRegulationforPharmaceuticalsandMedicalDevicesp.61.2ChallengingDecisionsofRegulatoryBodiesThatEnforcePharmaceuticalsandMedicalDevicesRegulationp.71.3DifferentCategoriesofPharmaceuticalsandMedicalDevicesp.72.ClinicalTrialsp.72.1RegulationofClinicalTrialsp.72.2ProcedureforSecuringAuthorisationtoUndertakeaClinicalTrialp.82.3PublicAvailabilityoftheConductofaClinicalTrialp.92.4RestrictiononUsingOnlineToolstoSupportClinicalTrialsp.92.5UseofDataResultingFromClinicalTrialsp.92.6DatabasesContainingPersonalorSensitiveDatap.93.MarketingAuthorisationsforPharmaceuticalsorMedicalDevicesp.103.1ProductClassification:PharmaceuticalsorMedicalDevicesp.103.2GrantingaMarketingAuthorisationforBiologicMedicinalProductsp.103.3PeriodofValidityforMarketingAuthorisationforPharmaceuticalsorMedicalDevicesp.103.4ProcedureforObtainingaMarketingAuthorisationforPharmaceuticalsandMedicalDevicesp.113.5AccesstoPharmaceuticalsandMedicalDevicesWithoutMarketingAuthorisationsp.123.6MarketingAuthorisationsforPharmac...