新药注册特殊审批管理办法(英文)-20090107.doc

《新药注册特殊审批管理办法(英文)-20090107.doc》由会员上传分享，免费在线阅读，更多相关内容在工程资料-天天文库。

1、(TranslationbyRDPAC,foritsmemberuseonly)NOTIFICATIONTOPUBLISHREGULATIONSOFSPECIALEXAMINATIONANDAPPROVALINNEWDRUGREGISTRATION(GuoShiYaoJianZhu[2009]17Hao)Toallfoodanddrugadministrationatprovinciallevelsandarmy:Inordertoencourageresearchanddevelopmentofnewdrugsandstrengthenriskcontrol,theStateFoodandD

2、rugAdministration(hereinafterSFDA)hasdevelopedRegulationsofSpecialExaminationandApprovalinNewDrugRegistrationinaccordancewiththeDrugRegistrationregulation,whichisherebypublishedforimplementation.SFDA7thJanuary2009REGULATIONSOFSPECIALEXAMINATIONANDAPPROVALINNEWDRUGREGISTRATIONArticle1:Therequirements

3、aredevelopedinaccordancewiththeDrugRegistrationRegulationforthepurposeofencouragingresearchanddevelopmentofnewdrugsandstrengtheningriskcontrol.Article2:InaccordancewithArticle45ofDrugRegistrationRegulation,theSFDAmayimplementspecialexaminationandapprovalinthecasesofthefollowingapplicationsofnewdrugs

4、:1)Activeingredientsextractedfromplants,animalsorminerals,etc.andtheirpreparationsnotyetmarketedinChina,andnewlydiscoveredChinesecrudedrugsandtheirpreparations;2)ChemicaldrugsubstanceandtheirpreparationsandbiologicalproductsnotyetapprovedformarketinginChinaorabroad;3)Newdrugsforthetreatmentofdisease

5、ssuchasAIDS,malignanttumorsandrarediseases,etc.withsignificantclinicaladvantages;and4)Newdrugsforthetreatmentofdiseases,forwhicheffectivetherapeuticmethodarenotavailable.Thenewdrugsforthetreatmentofdiseasesthatarenotcoveredbythestateapproved“Functions&IndicationsofTCMpreparations”,maybeconsideredasn

6、ewdrugsforthetreatmentofdiseasesforwhicheffectivetherapeuticmethodisnotavailable.Forthosedrugsspecifiedinitems1)&2),theapplicantofdrugregistration(hereinafter“theApplicant”)mayapplyforthespecialexaminationandapprovalwhensubmittingtheapplicationforclinicaltrialsofthenewdrugs.Forthosedrugsspecifiedini

7、tems3)&4),theApplicantmayapplyforthespecialexaminationandapprovalonlywhensubmittingtheproductionapplications.Article3:IfaregistrationapplicationmeetstherequirementsspecifiedinArticle2byreview&confirma