MedDRA関連の略号一覧 - pmrj.jp

1 MedDRA ADROITA dverse Drug Reactions On-line Information Tracking MHRA MedDRA ASCIIA merican Standard Code forInformation InterchangeAERSA dverse Event ReportingSystem FDA FDA FAERS BRP Blue Ribbon Panel (Meeting) MSSO MB MedDRA MedDRA CHMPC ommittee for MedicinalProducts for Human Use CIOMSC ouncil for InternationalOrganizations of MedicalSciences 1949 WHO COSTARTC oding Symbols for aThesaurus of Adverse ReactionTerms FDA CPMPC ommittee for ProprietaryMedicinal Products EMEA 2004 6 CHMP CTCAEC ommon Terminology Criteriafor Adverse Events NCI EFPIAThe European Federation ofPharmaceutical Industries andAssociations EMA European Medicines Agency European Agency for theEvaluation of Medicinal Products 2009 12 EMEA EMA EU RMPE

2 Uropean Union RiskManagemnet Plan FAERSFDA Adverse Event ReportingSystemFDA FDA FDA Food and Drug Administration HARTSH oechst Adverse ReactionTerminology System HLGT High Level Group Term MedDRA HLT High Level Term MedDRA ICD-9 International Classificationof Diseases - 9th Revision 9 ICD-9-CMInternational Classificationof Diseases - 9th RevisionClinical Modification 9 ICD-10 International Classificationof Diseases - 10th Revision 10 ICHI nternational Council forHarmonisation of TechnicalRequirements forPharmaceuticals for Human Use ICSR Individual Case Safety Report ICH E2B M2 IFCCI nternational Federation ofClinical Chemistry andLaboratory 1/2 MedDRA IFPMAI nternational Federation ofPharmaceutical Manufacturersand Associations IUPACI nterantional Union of Pureand Applied Chemistry J-ARTJ apanese Adverse ReactionTerminology WHO-ART JMOJ apanese MaintenanceOrganization MedDRA MedDRA JPMAJ apanese PharmaceuticalManufacturers Association LLT Lowest Level Term MedDRA LOINCL ogical ObservationIdentifiers Names and CodesRegenstrief Institute MCA Medicines Control Agency 2003 4 MHRA MedDRAM edical Dictionary forRegulatory ActivitiesICH MedDRA/JMedDRA

3 Terminology bundledwith Japanese TranslationICH MHLWM inistry of Health, Labourand Welfare MHRAM edicines and Healthcareproducts Regulatory Agency 2003 4 MCA MDA(Medical DevicesAgency) MSSOM aintenance and SupportServices OrganizationMedDRA NCI National Cancer Institute PhRMAP harmaceutical Research andManufacturers of America PMDAP harmaceuticals and MedicalDevices Agency 16 4 PRR Proportional reporting Ratio PT Preferred Term MedDRA ROR Reporting Odds Ratio SC Steering Committee ICH ICH SmPCSummary of ProductCharacteristics SMQ Standardised MedDRA Query MedDRA SNOMEDS ystematized Nomenclature of(Human and Veterinary)

4 MedicineCollege of American Pathologists 2007 IHTSDO International HealthTerminology Standard DevelopmentOrganization 7 SOC System Organ Class MedDRA SSC Special Search Category MedDRA MedDRA SMQ UMC Uppsala Monitoring Centre WHO WHO World Health Organization WHO-ARTW orld Health OrganizationAdverse Reaction Terminology 2/2