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2018 - 104 -

5

GVP

1

2014 11 25

1993 5

211995

7

1993 11 24999 1994 11 21 1445

31996 51997 4

3

1997 4 25 606

1997 4 25 59

1997 4 25 607

2003 5

2003 5 15

2018 - 105 -

05150052003 5 20

0520004 2003 7

2006 3 24 0324006

IT

2017 6 8 0608-(1)

2017 6 80608-(1)

2019 45

20148 6 0806-(3) GVP

i. 6

ii. PMDA HP

iii.

2014 9 10901-(1) PMDA HP

PMDA HPPMDA

PMDA

PMDA

PMDA2014

9 1

1.1 1)

2018 - 106 -

2

A4 4

2)

3)

1.2

18

19

3 60659 607

0515005 05200042005 4

2005 3 41332006 3 24 0324006

(1)

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(3)

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(5) JAN

(6)

(7)

(8)

(9)

(10)

(11) 606 59607 0515005

0520004 1.3 1.5

(12)

(13)

2018 - 107 -

(14)

(15)

(16)

(17)

(18)

(19)

(20)

1.3

60659 607

0515005 0520004

(1)

(2)

(3)

(4)

(5)

(6)

(7)

6072000 12 25

(8)

(9)

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(11)

(12)

(13)

(14)

(15)

15

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2500

WHO

1.4

2018 - 108 -

1988 101988 10 1 853

2002 3 13 170

1.5

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(1)

(2)

(3)

(4)

1.6

20009 19 935

25mg2004 6 2

0602009

2008 9 220922002 0922002

2012 3 310331001 0331001

2014 7 100710-(7) 0710-(5)

2005 9 220922001

2018 - 109 -

20132 14 0214-(1)

2013 8

2005 4

2 20099 5,400

1.7 HP

http://www.e-search.ne.jp/~jpr/

2

2.1

2015 9

662014

2015

2016

2017

2016

2001 10

(RMP)

RMP2017 6 5

4 . 1. GVP

2.2 IFIF

MR MR

MR

2013 42013 10

IF

2018 - 110 -

IFIF PDF

PMDA HP

3

PMDA

2014 11 25

PMDA HP

http://www.pmda.go.jp/files/000144200.pdfPMDA 1 2

PMDAPMDA

5

20 21PMDA

PMDA HPhttp://www.pmda.go.jp/safety/consultation-for-mah/0001.html

GVP

3.11)

2018 - 111 -

PMDA

2014 10 31 1031-(1)

2)

3)

MR

PMDA

PMDA

HP

HPPMDA

4)

1

3.2 1)

3.1 1)

PMDA

2014 10 311031-(1)

2)

3)

2018 - 112 -

MR

PMDA

PMDA

HP

HPPMDA

4)

1

3.3

2014 10 311031-(1) 2015 2 26

1291)

PMDA

PMDA

2)

3)

1) MR

PMDAPMDA

11

4)

3.4

3.5 Pharmaceuticals and Medical Devices

Safety Information

PMDA HP

WHO

1973 62001 6 167

2018 - 113 -

10 PMDA HP

http://www.pmda.go.jp/safety/info-services/drugs/calling-attention/safety-info/0043.html

3.6 DSU: Drug Safety Update

DSUOTC DSU OTC

DSU1992 9

2004 4 No. 128

10 1 19 6

5

OTC DSU OTC2015 11

PMDA HPhttp://www.pmda.go.jp/safety/info-services/dru

gs/calling-attention/dsu/0001.htmlhttp://www.pmda.go.jp/safety/info-services/drugs/calling-attention/dsu/0001.html

3.7

MR

1997 4

1997 6 27 88

200110

4 . 1. GVP

41997

1999 5 PMDAHP

http://www.pmda.go.jp/safety/info-services/drugs/0001.html

RMP

PMDA

SGML (Standard Generalized Markup Language)

PDF (Portable Document Format)

PMDA HP2019 4

SGML XML Extensible Markup Language

2018 - 114 -

20073

2009 5PMDA HP

PMDA

http://www.pmda.go.jp/safety/info-services/medi-navi/0006.html

5

1996 81998 9

1999 8 12

2011 1014

1999 8 12

2011 10 141014-(7) 1014-(8)

2013 3 27 0327-(1)0327-(1)

1991 3 27165 1991 6 3

2002 3 13170 2004 3

31

1652002 4 9 0409001

1991 6 3

1.4 2014 11 25

1.

62 3.2

PMDA HP

2014 8 6 0806-(3)

PMDA2014 9 1 0901-(1)

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2018 - 115 -

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PMS

2018 - 116 -

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9.9.1

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10.10.1

11.11.111.1.1

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12.

13.

14.

15.15.1

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16.16.1

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16.3

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2018 - 117 -

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16.7

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23.

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26.

2018 - 118 -

20 1

2018 - 119 -

21 2

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