01 OS MedDRAとは201103（final）.ppt [互換モード]

1 12 meddra /J . meddra meddra /J . 2011 20 .. JMO . meddra /J 1 meddra /J 2. Copyright (c) 2011 JMO Copyright (c) 2011 JMO.. meddra . 10028257.. Mumps Mumps .. Oreillons meddra /J . Parotite epidemica . meddra /J 3 meddra /J 4. Copyright (c) 2011 JMO Copyright (c) 2011 JMO.. FDA . FDA . specificity, granularity .. WHOART JART MEDIS . COSTART ICD9 ICD9CM . HART .. meddra /J 5 meddra /J 6. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 1. meddra meddra . 1990 . ICH meddra . ICH M1 . ICH Medical Dictionary for Regulatory Activities ICH . ICH . MSSO/JMO .. meddra ) M dDRA/J. meddra /J .. Medical Dictionary for Regulatory Activities/Japanese . meddra . version ICH EU International Conference on Harmonisation meddra Terminology bundled with Japanese Translation . of Technical Requirements for Registration of Pharmaceuticals for Human Use . ICH PMDA ICH.

2 ICH meddra /J 7 meddra /J 8. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. meddra . meddra meddra . Standaidisd meddra Queries (SMQ). 84 26.. System Organ Class (SOC).. 335. High Level Group Term (HLGT).. 1,710. High Level Term (HLT). biopharmaceutical industry 19,086. Preferred Term (PT).. Lowest Level Term (LLT). 69,019. meddra /J 9 meddra /J 10. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. meddra meddra . meddra .. meddra . / / .. WHOART . JART. COSTART. meddra . / . ICD9, ICD9CM .. HART .. MSSO/JMO AST100 .. meddra /J 11 meddra /J 12. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 2. meddra meddra . 1999 3 ICH . 2002 . 2003 .. 2005 8 . 2007 9 . 11 .. 2011 3 .. ICH 2009 9 .. meddra /J 13. 13 meddra /J 14. 14. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. meddra . ICH .. meddra . JMB IFPMA. MHLW/ MB .. JMO MSSO.. CR CR .. meddra /J 15 meddra /J 16.

3 Copyright (c) 2011 JMO Copyright (c) 2011 JMO. meddra MB meddra Management Board . IFPMA International Federation of Pharmaceutical Manufacturers and MB ICH meddra . Associations ICH .. meddra . meddra EU EFPIA FDA . PhRMA MHLW JPMA . MHRA Health Canada). MSSO Maintenance and Support Services Organization WHO . WHO .. IFPMA meddra MB ICH ICH . meddra SC .. JMO Japanese Maintenance Organization) MSSO . MSSO MSSO JMO . meddra /J .. meddra /J 17 meddra /J 18. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 3. meddra Blue Ribbon Panel Meeting meddra ICH meddra . MB . Change Request meddra . meddra . MSSO/JMO . MSSO meddra CTCAE .. BRP Blue Ribbon Panel) meddra . MB MSSO . External Expert Panel meddra . MSSO . Blue Ribbon Panel Meeting MB MSSO . meddra MSSO EU . HLT HLGT meddra . JMO . meddra /J 19 meddra /J 20. Copyright (c) 2011 JMO Copyright (c) 2011 JMO.

4 Change Request . meddra .. PT/LLT . LLT-PT PT-HLT . HLT HLGT meddra . SMQ / / SMQ .. MSSO . meddra .. meddra /J 21 meddra /J 22. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. meddra ICH E2B . ICSR Individual Case Safety Report .. ICH .. E2B .. ICH E2B B1 .. B2 . B3 . B4 . B5 . meddra /J 23 meddra /J 24. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 4. E2B meddra meddra /J .. meddra .. ( . LLT) . PT).. meddra PT LLT PT . meddra . E2B R3 2004 1999 12 . meddra /J 25 meddra /J 26. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 16 3 . 15 10 . meddra ICH E2B/M2 . meddra .. 90% .. meddra 100% . meddra . meddra /J 27 meddra /J 28. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. meddra . meddra . EU EU +8 .. ICSR EMA EudraVigilance EVCTM EVPM). (E2B/M2) meddra . Volume9A (Pharmacovigilance). 90% . meddra Volume10 (Clinical trials . EU-RMP (Risk Management Plan).

5 Volume2C SmPC Summary of Product Characteristics: FD meddra .. Eudravigilance .. FD . ICSR (Individual Case Safety Reports). meddra /J 29 meddra /J 30. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 5. meddra WHO-UMC meddra . FDA AERS meddra 1997 11 WHO Uppsala Monitoring Centre ; UMC ICH . meddra meddra . meddra meddra . 2003 3 .. meddra .. WHO meddra WHOART . 2009 8 UMC VigiBase .. meddra VigiBase meddra . WHO MSSO WHOART . E2B FDA . meddra . 80% 2008-2009 . 2008 . AERS . meddra /J 31 meddra /J 32. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. Eudravigilance EudraVigilance EMA EU EEA .. / ICSR EVCTM. EVPM . E2B meddra . Data .. 45,000 ICSR . Web .. Access Policy .. meddra /J 33 meddra /J 34. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. EU Risk Management Plan (RMP). VOLUME 9A. of The Rules Governing Medicinal Products in A set of pharmacovigilance activities and interventions the European Union designed to identify, characterise, prevent or minimise risks Guidelines on Pharmacovigilance for Medicinal Products for Human Use relating to medicinal products, including the assessment of the effectiveness of those interventions.

6 2008 9 Risk Risk meddra . Risk Risk meddra . Annex 229 . ICSR PSUR Signal detection meddra SMQ meddra Eudravigilance .. meddra /J 35 meddra /J 36. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 6. GUIDELINE ON THE USE OF STATISTICAL SIGNAL. Summary of Product Characteristics (SmPC) DETECTION METHODS IN THE. EUDRAVIGILANCE DATA ANALYSIS SYSTEM. This guideline will be included in The Rules Governing Medicinal Products in the European Union Volume 2C Notice to Eudravigilance . Applicants . CTD 1 . PRR Proportional Reporting Ratio . 4 3 4 4 4 8 meddra . meddra meddra PT SOC SMQ . / . meddra EMA . meddra Access Policy . 1999 12 2005 .. 2 2009 9 2010 5 2008 12 .. meddra /J 37 meddra /J 38. Copyright (c) 2011 JMO Copyright (c) 2011 JMO. 7. meddra meddra /J meddra .. meddra . meddra . meddra /J 2009 7 . meddra /J . meddra /J . meddra /J meddra /J.

7 Copyright (c) 2011 JMO 1 Copyright (c) 2011 JMO 2. PT: Preferred Term). meddra . Standaidisd meddra Queries (SMQ).. 85 26 19,086.. System Organ Class (SOC) PT LLT . 335 PT LLT .. High Level Group Term (HLGT). SOC . 1,710. High Level Term (HLT) SOC HLT, HLGT . SOC . 19,086. Preferred Term (PT) SOC. SOC PT SOC . 69,019. Lowest Level Term (LLT). meddra /J meddra /J . Copyright (c) 2011 JMO 3 Copyright (c) 2011 JMO 4. Lowest Level Term: LLT) PT LLT. 272 LLT 118 . meddra (PT) 10035829 (Poisoning by BCG vaccine). 10035819 (Poisoning by antipruritics).. 10035888 (Poisoning by opiate antagonists). 10004104 (Barbiturate intoxication). 10035844 (Poisoning by coronary vasodilators). PT 10035799 (Poisoning by anti-common cold drugs). 10035852 (Poisoning (P i i byb emetics). ti ). LLT 69,019. 10049614 (Poisoning by hypnotic). PT SOC LLT SOC 10035881 (Poisoning by mercurial diuretics).

8 LLT 10035957 (Poisoning by psychostimulants). 10035822 (Poisoning by antitussives). 10069565 (Sedative intoxication). 10021509 (Immunosuppressant intoxication). LLT .. meddra /J meddra /J . Copyright (c) 2011 JMO 5 Copyright (c) 2011 JMO 6. 1. HLT PT. High Level Term: HLT) 223 PT. 1,710. 10070416 (Influenza A virus test). PT 10070417 (Influenza A virus test negative). 10070215 (Influenza A virus test positive). 10019748 (Hepatitis C RNA). PT 10019749 (Hepatitis C RNA negative). 10068378 (Hepatitis C RNA decreased). meddra 10068377 (Hepatitis C RNA increased). 10068727 (Hepatitis C RNA fluctuation). HLT SOC . 10019750 . (Hepatitis ( C RNA positive)). 10070342 (Polyomavirus test positive). 10070368 (Poliovirus test). 10070367 (Poliovirus test negative). 10070341 (Poliovirus test positive). 10049031 (Genotype drug resistance test). 10066370 (Genotype drug resistance test abnormal).

9 10066369 (Genotype drug resistance test negative). 10066368 (Genotype drug resistance test positive).. meddra /J meddra /J . Copyright (c) 2011 JMO 7 Copyright (c) 2011 JMO 8. HLGT HLT. High Level Group Term: HLGT). HLT ( Lower limb fractures ). HLT HLT . HLT ( Thoracic cage fractures non-spinal (excl pathological) ). HLT ( Fractures NEC (excl pathological) ).. HLT ( Pelvic fractures ).. HLT ( Upper limb fractures ). HLT HLT ( Spinal fractures (excl pathological) ). HLT ( Skull and face fractures ). HLT ( Pathological fractures and complications ). SOC 335. SOC . NEC Not Elsewhere Classified . HLT HLT . meddra /J meddra /J . Copyright (c) 2011 JMO 9 Copyright (c) 2011 JMO 10.. System Organ Class: SOC) . 26. HLGT 26 .. SOC .. meddra PT SOC PT . SOC. SOC Primary SOC ; p-SOC . SOC . meddra /J meddra /J . Copyright (c) 2011 JMO 11 Copyright (c) 2011 JMO 12.

10 2. meddra JART .. PT SOC meddra . J-ART 96. 8 SOC PT . (SOC) . PT HLT, HLGT SOC 26 32 . SOC . (HLGT) . 335 . SOC .. (HLT). HLGT 1,710 . HLT. (PT) . 19,086 1984 . PT. (LLT) . HLT HLGT HLGT SOC 3126 . 69,019 . meddra /J meddra /J . Copyright (c) 2011 JMO 13 Copyright (c) 2011 JMO 14. meddra . SOC P_SOC 10018065 SOC 10040785 SOC 10021428.. PT HLT-HLGT SOC General disorders and administration site conditions Skin and subcutaneous tissue disorders Immune system disorders PT SOC . SOC . HLGT HLGT 10018073 HLGT 10002426 HLGT 10001708. SOC . General system disorders NEC.. Angioedema and urticaria . Allergic conditions SOC . PT SOC . SOC HLT HLT 10030113 HLT 10002425.. SOC Primary SOC ; p-SOC Oedema NEC Angioedemas SOC SOC SOC s-SOC . SOC PT 10016029. meddra PT . Face oedema SOC PT . meddra /J meddra /J . Copyright (c) 2011 JMO 15 Copyright (c) 2011 JMO 16.