2013日本药品注册管理办法.pdf

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1、2013.3INFORMATIONINENGLISHONJAPANESEREGULATORYAFFAIRSEnglishRegulatoryInformationTaskForceJapanPharmaceuticalManufacturersAssociationPharmaceuticalAdministrationandRegulationsinJapanMarch2013http://www.jpma.or.jp/about/issue/gratis/index2.html(Japanese)http://www.jpma.or.jp/english/parj/pdf/2013

2、.pdf(English)PharmaceuticalAdministrationandRegulationsinJapanThisfilecontainsinformationconcerningpharmaceuticaladministration,regulations,andnewdrugdevelopmentinJapanupdatedannuallybytheEnglishRAInformationTaskForce,InternationalAffairsCommittee,JapanPharmaceuticalManufacturersAssociation(JPMA

3、).Thecontentsarenotabstractsofgovernmentalrulesorregulationsbutconcisedescriptionsofmostcurrentpracticesbyregulatoryagenciesandtheindustrythattheworkinggroupcomplies.Thefiledoesnotcontainanythingrelatedtoforecasts.ThefileisavailablealsoatthehomepageofNationalInstituteofHealthSciences(http://www.

4、nihs.go.jp/kanren/iyaku.html).JapanPharmaceuticalManufacturersAssociationhttp://www.jpma.or.jp/english/4.9OfficeofNewDrugV··················9TableofContents4.10OfficeofCellularandTissue-basedProducts·············································94.11OfficeofVaccinesandBloodProducts···············

5、······························94.12OfficeofOTCandGenerics·········94.13OfficeofMedicalDevicesI··········9CHAPTER1··················································14.14OfficeofMedicalDevicesII·········104.15OfficeofMedicalDevicesIII········10ORGANIZATIONANDFUNCTIONOFTHEMINISTRYOF4.16OfficeofComp

6、lianceandStandardsHEALTH,LABOURANDWELFARE·························1101.PharmaceuticalandFoodSafetyBureau4.17OfficeofSafetyI·······················10(PFSB)··················································24.18OfficeofSafetyII······················101.1GeneralAffairsDivision·····················2

7、5.TheNationalInstituteofBiomedical1.2EvaluationandLicensingDivision·······2Innovation(IndependentAdministrative1.3SafetyDivision································4Agency)················································101.4Com