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                          腾讯3分彩个位计划网站

                          来源:药都在线  作者:   发表时间:2019-08-10 16:10:41

                          Rules coming for stem cell products, use#标题分割#Biotechrequiresqualitycontrolsbeyondnormaldrugs,expertssayChinaplanstosetadozenquality-controlstandardsforstemcelltherapiestoencourageinnovationintheboomingsector,medicalresearchersandhealthauthoritiessaid.InFebruary,theChineseSocietyforCellBiologyissuedanewsetofstandardsexplainingthebasicqualitiesofhumanembryonicstemcells-whichcandevelopintoavarietyoftissuetypes-layingouttechnicalguidelinesforqualitycontrolandtherequirementsforproductuse.Thisisthesecondstandardofitskind,followingtheintroductionofthegeneralrequirementsrelatedtostemcellsinlate2017,accordingtoZhouQi,directoroftheInstituteofZoologyattheChineseAcademyofSciences.ZhouisalsotheheadofCAS'sInstituteofStemCellandRegenerativeMedicine,whichistakingpartinthedraftingprocess."China'sresearchintothestemcellsectorhasenterednewterrainthathasnoprovenmethods,"hesaid."Therearemorethan10standardsunderdiscussionorawaitingapproval.Weareaimingtopromoteacomprehensivequality-controlframeworkthatwouldhelpregulatetheindustryandexpeditedevelopmentofmoreproductstomeetclinicaldemand."Inrecentyears,asthepotentialofstemcelltherapyhasbecomeevidenttodoctorsandscientists,confusionaboutoversightoftheindustryhasalsogrown.WuZhaohui,headoftheChinaMedicinalBiotechnologyAssociation,saideachstemcellisbothaliveandunique,andthusrequiresadifferentapproachthanwhatisusedinthemanufactureofconventionaldrugs.Stemcellsaddnewpressureforqualitycontrolinmassproduction,Wusaid.In2015,theNationalHealthandFamilyPlanningCommissionandNationalFoodandDrugAdministrationissuedasetofrulestoregulatestemcellresearch.Theyrequireresearchersusingstemcellstoabidebythesameguidingprinciplesasothermedicalproducts."TheruleshavepromptedustothinkabouthowtoenforcetheGoodManufacturingPractice-therequirementsfordrugs-inthecontextofstemcellresearchandproduction,"Wusaid."Thenewlyreleasedstandardsarepartofourattempttoresolvetheissue."Asmorestandardsareexpectedtoberolledoutinthenearfuture,hesaid,theyarelikelytofocusonthedifferenttypesoftissuesthatstemcellsdevelopinto,inabidtocreateacomprehensivestructureforsupervision.LiuGuisheng,anofficialwiththeNationalHealthCommission,saidstrongoversightismeanttostimulateinnovation."Sofar,35clinicalresearchprojectsusingstemcellshavebeenapproved,"hesaid."Sincespecificregulationsgoverningthemanufactureofstemcellproductsarestillinthepipeline,it'svitaltoworkwithprudenceandpatience."ZhangHui,anofficialwiththeNationalMedicalProductsAdministration,saidrulesreleasedin2015haveplayedanimportantroleinstrengtheningsupervisionandprotectingtherightsoftrialparticipants,buttheylackspecificsthatpointthewaytoviableavenuesuponcompletionofclinicalresearch."Forinstance,therulessaythatstemcellclinicalresearchapprovedwithintheframeworkmustnotbedirectlyappliedinclinicaltreatment,"hesaid."Thenthequestionis,Wherewillthisresearchendup"hesaid.Zhangaddedthatinothercountries,10stemcellproductshaveenteredthemarket,withfourmorerecentlyapprovedandmorethan300intheregistrationprocess."Butintermsoffundamentalresearch,Chinahasnotlaggedfarbehindotherdevelopedcountries,"hesaid.Thenewstandards-includingthegeneralrequirementsreleasedin2015thatcenteredonthesafety,efficacyandstabilityofstemcell-basedmedicalproducts-havehelped,hesaid.InChina,114medicalinstitutions,including12militaryhospitals,areallowedtoconductclinicalresearchusingstemcells,accordingtoWuShuxia,aresearcheroncelltherapypoliciesatamedicalsciencesacademyinBeijing.Shesaidthatotherthanbloodstemcells,whichprovideascientificallyproventreatmentforblooddisorders,includingleukemia,thetherapeuticmechanismsandrisksofmoststemcellproductsrequirefurtherclarification."Thereareaslewofrisksandissuesassociatedwithstemcellinjections,andwestilllackrigorousscientificevidencethatcanspeakvolumesabouttheirreliability,"shesaid.Shesuggestedthatresearchinstitutions,pharmaceuticalcompaniesandgovernmentsjoinforcestoprovideandsharemorescientificresultsandotherexperiencethatwouldhelpenhanceregulatorycapabilities.

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