2019 - 47 -

3

1

2013 84

1960145 14

2014 11 211121-(2)

14 3

1.1

14 3

1997 3 27 282016 1 22 9GCP

1997 3 2621 2008 6 13114 GLP

43

PMDA

8

1.2

GCP

2019 - 48 -

GCP

2003

PMDA 30

22

GCP

302003 5 15

89

PMDA

PMDA“ ” 1.4

31

2

a.2

b.

c.

d.

e.

ICH

DNAICH-M7

2016 1 15a e

DNA

2019 - 49 -

2015 11 101110-(3) 2018 6 27

0627-(1)

2015 12 14

2011 4 1

2013 5 31 0531-(8)

2008 4 1

2008 3 21 0321001

2014 2 1

2013 7 10701-(10)

201410 24 1024-(2)

1024-(1) 1024-(9) 1024-(15) 2016 11 221122-(4) 1122-(10)1122-(7) 1122-(4)

1.3

1995 3 20 227 ICH-E2A

ICH 19974

A: 7

2019 - 50 -

7

a)

b)

B: 1515

a)

b)

c)

d)

2008 2

ICH 2012 12 28

1611

2012 12 281228-(1) ICH E2F

2014 10 241024-(2) 1024-(1)

1024-(9) 1024 -(15) 201611 22 1122-(4)1122-(10) 1122-(7)1122-(4)

1.4

PMDA

PMDA

2012 32 0302070 2018 6 1

PMDA

PMDA HPhttp://www.pmda.go.jp/review-services/f2f-pre/consultations/0007.html

I

2019 - 51 -

IIII

II

IIIII /III

2011 9 10901-(1)

2016 1 22 0122-(12)0122-(2)

OTC

GCP/GLP/GPSP

GCP/GLP/GPSPGMP/QMSGCTP

2019 - 52 -

PMDA

GCP GLP

II

GMP/GCTP/QMS

PACMP

2018 3 90309-(1) 0309-(1)

Post-Approval Change Management Protocol;PACMP

PACMP

2019 - 53 -

PACMP

PACMP GMP

1.5

2014 11 21 1121-(2)

2014 11 21 1121-(12)PMDA HP

HPhttp://www.pmda.go.jp/review-services/drug-reviews/about-reviews/otc/0001.html

PMDA CTD

CTD2011 1 17

PMDAPMDA

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http://www.pmda.go.jp/files/000157674.pdfHP

http://www.pmda.go.jp/files/000153830.pdf

PMDA

PMDAHPhttp://www.pmda.go.jp/review-services/drug-reviews/user-fees/0001.html

2015 1 309

10

2010 6 9

6

1

CTD

6

6

MF

MFMF

MF

2019 - 54 -

CTD 2

GMP

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2014 10 61006-(1) 1006-(1)

1.6

1996 6

GLPGCP

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2010 5 280528027

GCP2010 5 28

0528028

GCP2012 10 12

1012063

2015 4 270427-(1) 2016 10 1

GCP

2016 5 11 0511005

2006 1 310131010 2014 11 21

1121-(5)

PMDAPMDA

EDC

2013 3 270327001 EDC

PMDA

GCPGCP 2006

1 31 01310062014 11 21 1121-(1)

42

GCP

PMDA HP 2017 31 PMDA GCP

GCP

PMDA

2019 - 55 -

http://www.pmda.go.jp/review-services/inspections/gcp/0002.html#r=s&r=s

1.7 GMP

GMP

GMP14 2 4

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0330001GMP

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EU GMPMRA 2003 5

2016 4 EU 28 MRA

2019 - 56 -

2016 4 260426-(3) 2018 7

GMP

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1.7.3

1999 6 262

2005 3 31

GMP

GMP

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2

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1999 48 6662005 4

2005 3 31 03310152008 10 20

10200012009 3 4 0304004

2013 7 10701-(10)

2014 6 12 0612-(6)481

2005 3 310331009

2008 10 20 1020002

2019 - 57 -

2009 34 0304015

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0612-(1)2014

11 211121-(2)

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ICH EUCTD

2001 6 21663

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2020 3 31

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2013 6 14PMDA

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20154 27 0427-(1) Q&A2018 5 17

Q&A2016 10 1

Clinical Data Interchange Standards Consortium

1. 1 1

2019 - 58 -

(1) 11

(2)

(3)GLP GCP

2004 5 27 0527004

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(6)

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/

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2019 - 59 -

(3)

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11. Common Technical Document (CTD)

CTD

FD FD

MF MFMF MF

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0927001

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4

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CTD

3

ICH

2019 - 60 -

1998 8 11739

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2006 10 5

PMDA

2007 9 280928010

2012 9 5

2014 10 27

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1999 2 1 4104

2019 - 61 -

1998 3 18256 265

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5 5

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1)

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ICHICH-Q6A ICH-Q6B

ICH2009 5 26

0526001 ICH-Q4BICH

6

1998 3 111-(5)

2)

2001 5 1 565ICH

2003 6 3 0603001ICH-Q1A(R2)

19975 28 422 ICH-Q1B

1997 5 28 425ICH-Q1C

2019 - 62 -

1998 16 6 ICH-Q5C

2002 7 31 07310042003 6 3

ICH-Q1D

1991 2 15165 43

3)

19899 11 1-(24)

ICH 7

3

1975 3 14 113

1978 6 7 383

2012 3 230323-(1)

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2010 6 40604-(1)

4) GLP

1997 326 21 2008 6 13

114 GLP

2001 6 21 902

GLPGLP

20086 13 0613007

8 19

1 1-4

2019 - 63 -

2 5-8

3 9 10

4 11 12

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6 15 16

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PMDA GLPGLP

PMDA GLPGLP

2008 6 200620058 2008 8 15 0815007

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GLP

2014 11 211121-(9) 1121-(13)

5)

8

ICH2001 6 21

902 ICH-S7AGLP

2019 - 64 -

1991 1 29 42001 6

21 902

2001 64 813

6)

9

1998 6 26 496in vitro

1996 7 2442 ICH-S3B

7

10

3.2

1)

ICH 3

1998 31998

4 21 380 ICH-E8

2019 - 65 -

5

GCP ICH

1997 3 2728 2016 1 229 GCP GCP

2013 7 1

2)

2.1

2010 2 190219-(4) ICH-M3R(R2) Q&A 2012 816(i)

(ii)

2.2)

2019 - 66 -

2008 7 9GMP 0709002

GMP Q&A2009 7 2

2.3)

4 IIV

3 ICH1998 4 21

380 ICH-E8

4

5

12

12 2

4

(i) I

I

II

2001 6 1796

2012 4 2 0402-(1)

(ii) II

II

II

III

IIII III

(iii) III

IIIIII

II

2019 - 67 -

1981 7

4 2005 11 1

(iv) IV

2.4)

2.5)

(i)

(ii)

(iii)

(iv)

In vitro in vivo1/100

GCP

2008 6 3 0603001

2019 - 68 -

3)

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GCP

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1996 5 1335 ICH-E3

4)

1992 3 4 20

199811 30 1047 ICH-E9 ICH

2019 - 69 -

5)

ICH ICH

11

6) GCP

GCP 198910 2 874 1990 10

1

1997 3 13

GCP 1997 327 28 1997 41

GCP2016 1 22 9GCP 6 59

3

2016 1 22 0122-(7)

7) GMP

GCP 17 “ ”

1997 3 31 480

2019 - 70 -

GMP 2008 79 0709002

GMP

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GMP GCP

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GMP 2000 11ICH 5

20

PIC/SGMP

2012 2 1

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4

4.1

DNADNA

1986 12 11 10511987 5 21 434 1995 8 18

769

2019 - 71 -

GILSP Good Industrial Large Scale Practice 1

2 3 4

2003 6 18 97

2004 1 291

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DNA

1984 3 30 243

1988 6 6 1 10

2017 7 5 0705-(5)

ICH

12

4.2

200012 1

2000 12 1

2000 12 26 1314

26.4 BSE

2002 7 31

2003 5

2003210

2013

BSE

2014 375

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2019 - 72 -

2009 3 40304007

ICH Q5E

Q&A2009 7 21 2010 3

31 2015 12 15

2009 3 4 03040079

2012 4 26 0426-(2)

4.4

1999 11 11 1651

2002 5 29 0529003

2005 4 220422001 2005 4 22 0422004

2007 11 26 11260052013 3 25 0325-(1)

PMDA

HPhttp://www.pmda.go.jp/PmdaSearch/iyakuSearch

HPhttp://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html

2005 1 6IFPMA PhRMA

EFPIAJPMA

1

2019 - 73 -

UMIN (UMIN-CTR;

http://www.umin.ac.jp/ctr/index-j.htm

JapicCTI JAPIC Clinical Trial Information http://www.japic.or.jp/index.html

jRCT(Japan Registry of Clinical Trials)JapicCTI

2018 3 260326-(3)

2013 5 150515-(5)

0331-(9)2017 3 31

4.5 ICH

ICH1990 4

6 ICHEU EFPIA MHLW JPMA FDA

PhRMA Swissmedic Health CanadaWHO IFPMA

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13 ICH 70

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HPhttps://www.pmda.go.jp/int-activities/int-harmony/ich/0014.html

HPhttp://www.ich.org/home.html

2019 - 74 -

PMS

8

PMDA

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PMDA

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PMDA

GCP1. 2. 3.

2019 - 75 -

201412

201335

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GMP

2575

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2019 - 76 -

20149

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2019 - 77 -

32014 11 21 1121 2 2-(1)

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2019 - 78 -

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2019 - 79 -

42014 11 21 1121 2 2-(2)

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4(4)

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2019 - 81 -

5

2019 - 82 -

6

7551995 7 20

ICH-Q2A Q2A(R1)877

1995 9 25

1204001 2006 12 4

ICH-Q3A Q3A(R2)539

1997 6 23

0703004 2006 7 3ICH-Q3B Q3B(R2)

3381997 10 28

ICH-Q2B Q2(R1)307

1998 3 30

0719-(3) 2018 7 19ICH-Q3C Q3C (R5)

0930-(4)2015 9 30

ICH-Q3D568

2001 5 1ICH-Q6A

5712001 5 1

ICH-Q6B574

2001 5 1

09010012006 9 1

0628-(1) 2010 6 28ICH-Q8

0616-(1)2011 6 16

0710-(9)2014 7 10

ICH-Q11

Q&A 2018 9 14

2019 - 83 -

DNA 1110 –(3)2015 11 10

ICH-M7

0627-(1) 2018 6 270927-(3)

2018 9 27

2019 - 84 -

7

881993 8 10

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5441996 8 6

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3151997 14

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5481998 7 9

ICH-S1B1019

1998 11 13

18312000 12 27

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Q&A 2012 8 16

16041999 11 1

ICH-S21607

1999 11 1

1127001 2008 11 27

04180012006 4 18

ICH-S8QT 1023-(4)

2009 10 23ICH-S7B

2019 - 85 -

0920-(2)2012 9 20

ICH-S2 (R1)1002-(5)

2012 10 2

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ICH-S10

8

41991 1 29

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ICH-S7A813

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9

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0711-(1)2013 7 11

Q&A 2013 7 11

0401-(1)2014 4 1

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0723-(4)2018 723

Q&A 2018 7 23

2019 - 86 -

10

0229-(10)2012 2 29

0229-(10)2012 2 29

0229-(10)2012 2 29

0229-(10)2012 2 29

11240042006 11 24

11240012006 11 24

1101 -(1)2010 11 1

Q&A 2013 4 19

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11

11-(10)

1987 4 211-(22)1987 10 31

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2017 10 23742

1999 4 152017 7 70707-(1)

01280012002 1 28

ICH-E12A ICH-E120325035

2004 3 250512001

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2019 - 87 -

11010012005 11 1

2005 11 2

02170012006 2 17

06280012006 6 28

0527-(5)2010 5 27

0709-(1)2010 7 9

2014 5 191116-(1)

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2011 3 290930-(1)

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2011 12 130930-(1)

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2016 4 72

1041993 12 2

ICH-E7 (2010 9 17Q&A

2010 9 17494

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5921995 5 24

ICH-E1335

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3801998 4 21

ICH-E8672

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Q&A 2006 10 5Q&A 2

10471998 11 30

2019 - 88 -

ICH-E91334

2000 12 15ICH-E11

1227-(5)2017 12 27

ICH-E11(R1)136

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06030012008 6 3

QT/QTc 1023-(1)2009 10 23

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7 3 Q&A2

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0612-(1)2018 6 12

ICH-E173

11(4) 198015(2) 198415(6) 198416(3) 1985

1-(5)1988 3 11

1031-(1)2011 10 31

0611-(1)2012 6 11

0701-(10)2013 7 1

2013 12 26PK PD 1225-(10)

2015 12 250328-(19)

2016 3 28siRNA

2016 3 28

2019 - 89 -

12

3292000 2 22

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0323-(1)2012 3 23

ICH-S6(R)0701-(4)

2013 7 1

0701-(7)2013 7 1

2019 - 90 -

11 Common Technical Document (CTD)

2019 - 91 -

12

2018 - 92 -

Quality Safety Efficacy Multidisciplinary

Step 5

Q1A(R2)Q1BQ1CQ1DQ1EQ2(R1)Q3A(R2)Q3B(R2)Q3C(R5)Q3DQ4BQ4B(Annex1)(R1)Q4B(Annex2)(R1)Q4B(Annex3)(R1)Q4B(Annex4A, 4B, 4C) (R1)

Q4B(Annex6)(R1)Q4B(Annex5)(R1)Q4B(Annex7)(R2)Q4B(Annex8)(R1)Q4B(Annex9)(R1)Q4B(Annex10)(R1)Q4B(Annex11)Q4B(Annex12)Q4B(Annex13)Q4B(Annex14)Q5A(R1)Q5BQ5CQ5DQ5EQ6A

Q6BQ7Q8(R2)Q9Q10Q11

&

&

ICH

/ 3

GMP

S1AS1BS1C(R2)S2(R1)S3A

S3BS4S5(R2)S6(R1)S7AS7BS8S9S10

QT

E1

E2A

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E2C(R2)E2DE2EE2FE3E4E5(R1)E6(R1)E7E8E9E10E11E12E14

E15E16

(ICSR)

(PBRER)

(PvP)(DSUR)

QT/QTc

M1M2M3(R2)M4M4E(R2)M7

M8M8

ICH (MedDRA)

CTDDNA

v.3.2.2v.4.0

Step 4

Q3C(R6) E6(R2) E11(R1)E17E18

M7(R1) DNA

Step 3 S5(R3) E9(R1)

Step 2a/2b Q12

Step 1

Step 1Q3C(R7) S1

S11E19E8(R1)E11A

M9M10

BCS

1 Step1 Step 2a/2b /Step 3 Step 4 Step 5

2 Q&A

13 ICH 2017 11 17

http://www.pmda.go.jp/files/000221387.pdf