混合診療と新薬"認可" - Umin

混合診療と新薬"認可" - Umin

FDA (PMDA)PMDA)

Japan MHLW approval Universal health insurance coverage

USA Health insurance system A FDA approval Health insurance system B Health insurance system C

20 05 3 15 15 04 7 PMDA 3

(1997 7 200 3 ) GCP/GLP

( 2004 4 ) GCP/GLP

HeadQuarters

RCT

2004/12 105

Quality Control

FDA

PMDA

Japan MHLW

approval Universal health insurance coverage USA Health insurance system A FDA approval

Health insurance system B Health insurance system C 100% 90% 80% 70% 60% 62

66 50% 76 86 86 88 87

87 3 3 1 2 2 40%

30% 20% 10% 0% 27 23 13

Reviewers in FDA R CDER/CBE

Statistical Reviewers (98) N=2,735 Data for CDER/CBER, 11/2000 FDA Office of Budget Admin (218) Chemistry Reviewers (323) Computer Specialist (112) Consumer Safety

Officer (339) Project Manager Pharmacist (47) Pharmacology Medical Reviewers (336) Physiology Toxicology Pharmacology/Toxicology Reviewers (~204)

General Health Science (185) PMDA 250 Medical reviewer 9 3

FDA BSE COX 2

EU , FDA, EU/EMEA, , PhRMA, EFPIA (obs.) WHO, , EF TA 10 PhRMA

ICH European Commission EFPIA FDA MHLW FDA

EU 50

GCP E5 )

ADH 56 40 4 100 0 0

CYP450

HIV HIV DOT

1956 1961 1964 1965

1975 1989 HIV 1993 1996 CJ D Risk Benefit Cox2

FDA Gold Standard FDA COX2 FDA

1 8-10 2-3 3-4 1-2 1-2

ICH GCP Reviewers in FDA R CDER/CBE Statistical Reviewers (98) N=2,735

Data for CDER/CBER, 11/2000 FDA Office of Budget Admin (218) Chemistry Reviewers (323) Computer Specialist (112) Consumer Safety Officer (339) Project Manager Pharmacist (47)

Pharmacology Medical Reviewers (336) Physiology Toxicology Pharmacology/Toxicology Reviewers (~204) General Health Science (185) PMDA 250 Medical reviewer 9 3

:[email protected]@mail.goo.ne.jp

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