日本药事法规介绍

APPENDIX2004.3.PharmaceuticalAdministrationandRegulationsinJapan://(JPMA)“NEW”DRUGSRECENTLYAPPROVED..........................................................................12APPENDIX3IMPORTANTNOTIFICATIONSANDORDINANCESRELATEDTOBIOLOGICALPRODUCTS.....................................................................................................................................................16APPENDIX4RECORDSOFGCPINSPECTION......................................................................................20APPENDIX5EDUCATIONOFMEDICALREPRESENTATIVES(MR)....................................................21Appendix,JapanesePharmaceuticalAdministrationandRegulationsAppendix1RevisionofPharmaceuticalSystemSource:PharmaceuticalManufacturingManager’sTrainingCourse,September2002Generalexplanation1.RevisionofthePharmaceuticalAffairsLawThefollowingthreemainrevisionsinthepharmaceuticalsystemweremadeintheamendmentofthePharmaceuticalAffairsLawenactedonJuly31,2002.(1)Augmentationofsafetyassurancepoliciesinthiscenturyofbiotechnologyandgenomics(2)Radicalrevisionofsafetypoliciesformedicaldevices(3)Augmentationofpost-marketingsafetypoliciesandrevisionoftheapprovalandlicensingsystemAugmentationofsafetyassurancepoliciesinthiscenturyofbiotechnologyandgenomicsincludesthesystemforbiologicalproductsconsistingofimportantmeasurestoassuresafetybasedonadefinitionofbiologicalproducts,classificationofproductsbasedontheriskofinfectionandthecharacteristicsofbiologicalproducts.ThissystemwasenforcedonJuly30,2002.Thedraftofgovernmentordinancesonaugmentationofpost-marketingsafetypoliciesandrevisionoftheapprovalandlicensingsystemwasopenedtopubliccommentfromJune17toAugust17,2002andawiderangeofopinionswerecollected.TheinvitationofpubliccommentsfortherevisedGMPwasextendedtoAugust29.Atpresent,theopinionsarebeingusedasareferenceforarevisionofthePharmaceuticalAffairsLaw.TheordinanceforrevisionwillbeissuedthisautumnandtherevisedPharmaceuticalAffairsLawwillbeenforcedin2005.2.EstablishmentoftheGeneralOrganizationforDrugsandMedicalDevicesAfterthebillwaspassedattheendof2002,preparationshavebeenunderwaytoestablishtheGeneralOrganizationforDrugsandMedicalDevicesonApril1,2005.Theneworganizationwillfirstinitiateanewsystemtoprovidereliefforhealthdamageincludinginfectionsrelatedtobiologicalproductsoncenewsafetymeasuresforbiologicalproductsareinforce.ThesystemwillbeestablishedtocoincidewiththeenforcementoftherevisedPharmaceuticalAffairsLawin2005.Thereviewsystemisunderinvestigationbasedonthefollowingpoints:(1)Unificationofclinicaltrialconsultationsandreviews(2)Assuranceofbetterqualityreviews,transparencyofthereviewprocessandshorteningof-1-Appendix,JapanesePharmaceuticalAdministrationandRegulationsthereviewperiod.(3)Introductionofafast-tractclinicalconsultationsystemandaugmentationofthefast-tract(priority)reviewsystem.Thefollowingpointstostrengthensafetymeasuresarealsounderinvestigation.(1)Unificationofcollectionofadversedrugreaction(ADR)reportsbythenewOrganizationandunderstandingofimportantsafety-relatedinformationbytheMinistrywithnoleaks(2)Qualitativeimprovementofsurveys,analysisandevaluationofsafetyinformation(3)Augmentationoftheconsultationsystemforcompanies(4)AugmentationoftheinformationdisseminationsystemThegovernmentplanstotakemeasurestosecurefundsrequiredfortheaugmentationandstrengtheningofthesesystems,andalsoplanstoincreasereviewfeesandcollectcontributionsfornewsafetymeasures.Inthefuture,coordinationwithrelatedpersonswillcontinueandpreparationsarebeingmadetoestablishanorganization,whichishighlyspecialized,transparent,neutralandefficientinkeepingwithanindependentadministrativecorporation.3.QualityreevaluationQualityreevaluationforgenericproductswasestablishedinFebruary1997toassurereliablequalityincludingdissolutionoforalsolidproducts.Dissolutionspecificationsoforalsolidproductsaregraduallybeingestablishedandthesuitabilityofthegenericproductsisbeingconfirmed.Onanannualproductionbasis,morethan95%ofgenericproductshavebeendesignatedforqualityreevaluationandqualityreevaluationhasbeencompetedonabout80%oftheproducts(250ingredientsin2,140productsasofAugust2003).The16theditionoftheOrangeBookcontainingtheresultsofreevaluationofeachoftheproductsforwhichqualityreevaluationhasbeencompletedandthedissolutiontestspecificationscompiledwaspublished.Workontheremainingproductscontinuesandcompletionisexpectedin2004.4.Handlingnon-prescriptionproductsStandardsconcerningtheingredientsandquantities,dosageandadmi