全球法律指南：生命科学2024（英）.pdf

CHAMBERSGLOBALPRACTICEGUIDES

LifeSciences

2024

Definitivegloballawguidesoffering

comparativeanalysisfromtop-rankedlawyers

China:LawPractice

AlanZhou,CocoFan,

StephanieWangandKellyCao

GlobalLawOffice

CHINA

LawandPractice

Contributedby:

AlanZhou,CocoFan,StephanieWangandKellyCao

GlobalLawOffice

Contents

1.LifeSciencesRegulatoryFrameworkp.6

1.1LegislationandRegulationforPharmaceuticalsandMedicalDevicesp.6

1.2ChallengingDecisionsofRegulatoryBodiesThatEnforcePharmaceuticalsandMedicalDevicesRegulationp.7

1.3 Different Categories of Pharmaceuticals and Medical Devices p.7

2.ClinicalTrialsp.7

2.1RegulationofClinicalTrialsp.7

2.2ProcedureforSecuringAuthorisationtoUndertakeaClinicalTrialp.8

2.3PublicAvailabilityoftheConductofaClinicalTrialp.9

2.4RestrictiononUsingOnlineToolstoSupportClinicalTrialsp.9

2.5UseofDataResultingFromClinicalTrialsp.9

2.6DatabasesContainingPersonalorSensitiveDatap.9

3.MarketingAuthorisationsforPharmaceuticalsorMedicalDevicesp.10

3.1 Product Classification: Pharmaceuticals or Medical Devices p.10

3.2 Granting a Marketing Authorisation for Biologic Medicinal Products p.10

3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices p.10

3.4ProcedureforObtainingaMarketingAuthorisationforPharmaceuticalsandMedicalDevicesp.11

3.5AccesstoPharmaceuticalsandMedicalDevicesWithoutMarketingAuthorisationsp.12

3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations p.13

3.7Third-PartyAccesstoPendingApplicationsforMarketingAuthorisationsforPharmaceuticalsandMedical

Devicesp.13

3.8RulesAgainstIllegalMedicinesand/orMedicalDevicesp.14

3.9BorderMeasurestoTackleCounterfeitPharmaceuticalsandMedicalDevicesp.14

4.ManufacturingofPharmac