HISAMITSU REPORT--PHASE 1.pptVIP免费

PhaseIReport：SurveyandEvaluationofChinaMarketforHisamitsuChinaMarketEntryProjectMarch3,2004April30,2025Confidential,Copyright@2003bySinotrust2HisamitsuChinaMarketEntryStrategyContentsRegulations,policiesandproceduresofdrugapplicationMainrelevantregulationsandpoliciesMainapplicationproceduresPreliminaryanalysisforHisamitsuMarketanalysisrelevanttoHisamitsu’sproductsChinadrugmarketanalysisChinaskin-careproductmarketanalysisApril30,2025Confidential,Copyright@2003bySinotrust3HisamitsuChinaMarketEntryStrategyMainrelevantregulationsandpoliciesApril30,2025Confidential,Copyright@2003bySinotrust4HisamitsuChinaMarketEntryStrategyOverviewofregulationsandpoliciesforChinapharmaceuticalindustryChina'sreviseddruglawwentintoeffect1December2001aftertheamendmenttotheformerdruglawwasofficiallylaunchedinOctober1998.ThenewlyrevisedDrugLawwillbringaboutalong-soughttransformationofChina'smedicineindustry.ThedomesticpharmaceuticalindustrywillfacegreatchallengeswithChina'sWTOentry.Itisnecessarytokeeptheadministrationofhigh-qualitymedicineinlinewithinternationalstandardsifdomesticpharmaceuticalenterprisesaretocompeteagainsttheirforeigncounterparts.Thenewlawwilltreatforeignmedicineequallyasdomesticbrandsbyfirstlystoppingthepracticeofexaminingtheimportedmedicineandthenshiftingthefocustomarketsupervision.ThecurrentProvisionforDrugRegistrationhasaddedmanynewitemssuchastheregulationonthequalificationofdrugregistrationapplicant,theclassificationofdrugregistrationapplication,theprotectionoftheundisclosedtrialdataandetc.ThecurrentProvisionforDrugRegistrationismorereasonableandsuitableforChina'sentryintoWTOandfurtherguaranteethatsafeandeffectivedrugsareavailabletotheChinesepeople.April30,2025Confidential,Copyright@2003bySinotrust5HisamitsuChinaMarketEntryStrategyThereare5kindsofregulationsandpolicies(totalin26)aboutdrugandcosmeticimportapplicationrelevanttoHisamitsu’sproductsNO.TypesofRegulationsandPolicyQuantity1TheMostimportantRegulationsandPolicy22Pharmaceuticalindustry(drugs)93Healthsupplements（cosmetics,Medicaldevices）64Intellectualpropertyrights65Foreigninvestment3Total26Note:SourcefromSFDATypeandQuantityApril30,2025Confidential,Copyright@2003bySinotrust6HisamitsuChinaMarketEntryStrategyThemostimportantregulationsandpolicyregulationsandpoliciesaboutpharmaceuticalindustryNO.TitleTimeLaunchedTheDepartmentofGovernmentMainContent1DRUGADMINISTRATIONLAWOFTHEPEOPLE'SREPUBLICOFCHINADec1,2001The20thMeetingoftheStandingCommitteeoftheNinthNationalPeople'sCongressThisLawisenactedtostrengthendrugadministration,toensuredrugqualityandsafetyforhumanbeings,toprotectthehealthofpeopleandtheirlegitimaterightsandinterestsintheuseofdrugs.2DRUGREGISTRATIONREGULATIONAug6,2002StateFood&DrugAdministration(SFDA)ThisRegulationispromulgatedaccordingtotheDrugAdministrationLawofThePeople’sRepublicofChinatoensurethesafety,efficacyandqualitycontrolofdrugsandstandardizedrugregistration.Note:SourcefromSFDATitleandMainContentApril30,2025Confidential,Copyright@2003bySinotrust7HisamitsuChinaMarketEntryStrategyDrugadministrationlawofthePeople’sRepublicofChinaChapterNO.ChapterTitleMainContent1GeneralProvisionsAllinstitutionsandindividualsengagedinresearch,production,distribution,use,ordrugadministrationinthePeople'sRepublicofChinashallabidebythisLaw.2ControloverDrugManufacturersDrugmanufacturersshallconductproduct...