???FDA? ?????????? - PowerPoint PPT Presentation

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???FDA? ??????????

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Title: ???FDA? ??????????


1
???FDA???????????
  • ?????????????????????(PMDA)??????

2
?????
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  • ?????,?????????????
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3
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4
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  • ?????,???????(??????)
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5
(No Transcript)
6
(No Transcript)
7
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8
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9
Japan
USA
Health insurance system A
FDA approval
MHLW approval
Health insurance system B
Universal health insurance coverage ?????
Health insurance system C
10
?????????????????????????
?????????????????????2005?3??????(?)??????????????
?????????????????????????????15??????15???????????
?????????????????????????04?7???????????????(PMDA?
??) ?????????3????????????????????????????????????
?????(???)????????????????????????????????????????
?????????????? (?????????)
11
(No Transcript)
12
??????????,?????????????
13
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14
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?? ????????????????????
????,?????????!!
15
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16
?????????? (1997?7?2004?3?)
????
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GCP/GLP ?????
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17
?????????? ( 2004?4???)
???(??)
????/?????
??
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GCP/GLP ?????
??????
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??
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HeadQuarters
?????
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??
18
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19
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20
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21
??????
  • ?????????????(????16??????3?)????????(??33????6???
    ?9?)?????
  • ??13?52?(??33??????19?)
  • ??14?31?(??10??????21?)
  • ??15?79?(??53??????26?)
  • 2004/12??,97??303?,105??

22
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23
??????????????????????????
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  • Quality Control???????

24
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25
???(???????)???????????
26
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27
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  • ??????????
  • ?????
  • ??????(?)??????????
  • ???????????
  • FDA????
  • ??????????????????????????????PMDA?????!!

28
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29
??????????,??????????????
??????? ????!!
30
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??????????? ?????????
31
?????
  • ????????????

32
Japan
USA
Health insurance system A
FDA approval
MHLW approval
Health insurance system B
Universal health insurance coverage ?????
Health insurance system C
33
(No Transcript)
34
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35
(No Transcript)
36
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37
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38
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39
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40
(No Transcript)
41
(No Transcript)
42
??????????????????????????
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  • ??????,???????

43
??????????
??????
?????? ??????????
44
??
45
Reviewers in FDA (CDER/CBER)
N2,735 Data for CDER/CBER, 11/2000 FDA Office
of Budget
Statistical Reviewers (98)
Chemistry Reviewers (323)
Admin (218)
Computer Specialist (112)
Consumer Safety Officer (339)
Project Manager
Pharmacist (47)
Pharmacology
Physiology
Pharmacology/Toxicology Reviewers (204)
Medical Reviewers (336)
Toxicology
General Health Science (185)
????PMDA????250??Medical reviewer?9???????3??
46
??????????????2?3
47
??????????????????????????????
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  • FDA?????BSE,COX?2???
  • ?????????????????
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  • ??????????

48
??????????????????EU???????????(ICH)
?????, FDA, EU/EMEA, ???, PhRMA, EFPIA (obs.)
WHO,????, EFTA
???????????(??????)
10??
??
PhRMA
FDA
???
MHLW
FDA
ICH
?????
6?????????????
??
European Commission
EU
???????
EFPIA
??
50??????????????????(??????????? GCP ?
E5?????????)
49
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50
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51
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52
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53
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54
?????
55
?????
Risk
Benefit
56
???????????????????
  • Cox2???(???)?????
  • ????????????
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  • ????????????
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  • ??????????
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57
FDA?Gold Standard????
  • ???????????
  • FDA????
  • COX2??????
  • FDA??????????
  • ?????????
  • ????????

58
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16?4????????????
59
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60
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61
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62
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63
????????? ??????? ??
1???8-10??????????? ?????
?? 2-3? ?? 3-4? ??? 1-2? ????? 1-2?
64
????????????
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  • ??????????????????
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  • ????????
  • ????????
  • ICH???????????,??GCP??
  • ??????????

65
???????
66
Reviewers in FDA (CDER/CBER)
N2,735 Data for CDER/CBER, 11/2000 FDA Office
of Budget
Statistical Reviewers (98)
Chemistry Reviewers (323)
Admin (218)
Computer Specialist (112)
Consumer Safety Officer (339)
Project Manager
Pharmacist (47)
Pharmacology
Physiology
Pharmacology/Toxicology Reviewers (204)
Medical Reviewers (336)
Toxicology
General Health Science (185)
????PMDA????250??Medical reviewer?9???????3??
67
????????????!!
????ikecell_at_mail.goo.ne.jp
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