ReportontheDeliberationResults
February10,2022
PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau
MinistryofHealth,LabourandWelfare
BrandNamePaxlovidPACK
Non-proprietaryNameNirmatrelvir(JAN*)andRitonavir(JAN*)
ApplicantPfizerJapanInc.
DateofApplicationJanuary14,2022
ResultsofDeliberation
Underthecurrentpandemicofdiseasecausedbyanovelcoronavirus(severeacuterespiratory
syndromecoronavirus2[SARS-CoV-2]),theapplicanthassubmittedanapplicationforapprovalof
theproductontheunderstandingthattheproductisqualifiedforapprovalbasedonArticle14-3,
Paragraph1oftheActonSecuringQuality,EfficacyandSafetyofProductsIncluding
PharmaceuticalsandMedicalDevices(ActNo.145of1960,hereinafterreferredtoasthe
“PharmaceuticalsandMedicalDevicesAct”).
InitsmeetingheldonFebruary10,2022,theSecondCommitteeonNewDrugsdiscussedwhetherthe
productwasqualifiedforSpecialApprovalforEmergencyunderArticle14-3,Paragraph1ofthe
PharmaceuticalsandMedicalDevicesAct.TheCommitteeconcludedthattheproductmaybe
approvedwiththeconditionslistedbelow,andthatthisresultshouldbepresentedtothe
PharmaceuticalAffairsDepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.
Th