2018 - 42 -

3

1

25 84

35145 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

GCP

2003

PMDA 30

2018 - 43 -

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

201511 10 1110-(3)

2015 12 14

2018 - 44 -

2011 4 1

2013 5 31 0531-(8)

2008 4 1

2008 3 21 0321001

20142 1

2013 7 10701-(10)

1.3

1995 3 20 227 ICH-E2A

ICH 19974

A: 7

7

a)

b)

B: 1515

a)

b)

c)

d)

2008 2

ICH 2012 12 28

1611

2018 - 45 -

2012 12 281228-(1) ICH E2F

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

1024-(9) 1024 -(15) 2016 1122 1122-(4)

1122-(10) 1122-(7)1122-(4)

1.4 PMDA

PMDA

2012 3 20302070 2018 1 4

PMDA

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

I

II

II

II

I

II

II /III

2011 9 10901-(1)

20161 22 0122-(12)

0122-(2)

2018 - 46 -

OTC

GCP/GLP/GPSP

GCP/GLP/GPSP

GMP/QMS

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PMDA

GCP GLP

( II)

2018 - 47 -

GMP/GCTP/QMS

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.pdf

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

PMDA

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

2015 1 309

2010 6 9

6

1

CTD

6

6

MF

MFMF

MF

2018 - 48 -

CTD 2

GMP

PMDA

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

1.6 1996 6

GLPGCP

PMDA

2010 5 280528027

GCP2010 5 28

0528028

GCP2012 10 12

1012063

2015 4 270427-(1) 2016 10 1

GCP2016 5 11 0511005

2006 1 310131010 2014 11 21

1121-(5)

PMDAPMDA

GCP

2012 112014

3 PMDA

EDC

2013 327 0327001

EDC

PMDA

GCPGCP

2006 1 310131006 2014 11 21

1121-(1)

4

2

GCP

GCPEDC

PMDA

PMDA HP2017 3 1 PMDA

2018 - 49 -

GCP GCP

PMDA

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

1.7 GMP

GMP

GMP14 2 4

GMP

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0330001GMP

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B

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GMP

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GMP

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EU GMPMRA 2003 5

2016 4 EU 28 MRA2016 4 26

0426-(3)

PIC/SGMP

2012 3

2018 - 50 -

PMDA PIC/S2014 7 1

PIC/S GMP 2012 2 1

2017 8 92013 8 PIC/S GMP

GMP 2005 3 300330001

2013 8 30 0830-(1)

1.7.3

1999 6 262

2005 3 31

GMP

GMP

2005 4 1

2015 122016 1

2

1999 4 8 4812004 5 25 0525003

1999 4 8666

2005 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 10200022009 3 4

03040152013 7 1

0701-(10)2014 6 12

0612-(1)

2014 11 211121-(2)

1121-(12)

ICH EUCTD

2001 6 21663

2018 - 51 -

2001 6 21899 2017 2 2

0202-(1) CTDCTD

25 1

3 5 CTD

2017 2 2

CTD eCTD

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0707-(3) Version3.2.2 200910 1

Q&A

2004 5 270527004 2017 7 5

2017 7 5eCTD0705-(1)

eCTDQ&A

eCTD Version 4.0 ICH eCTD

2016 10 1eCTD

2020 3 31

25 6 14PMDA

25 6 14PMDA

2014 6 200620-(6) Q&A 2014 6 20

2015 4 27 0427-(1)Q&A 2015 4 27

Q&A2016 10 1

Clinical Data Interchange Standards Consortium

1. 1 1

(1) 1

1

(2)

(3) GLP GCP

20045 27 0527004

(4)

(5)

(6)

(7)

(8)

(9)

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(13)

2018 - 52 -

CTD 2011 1 17

/

2017 6 23

eCTD

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(1) 2 2 55

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(2)

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(4)

10. Common Technical Document (CTD)

CTD

FD FD

MF MFMF MF

2016 10 71007001

2.1 2.1.1

2018 - 53 -

2014 11 21 1121-(2)1 2-(1) 3.

(1) (8 2) (9) (10)(10 4)

CTD8 2 10 10 4

2018 2 28

2.1.2

25 103 2014 6 12

4

2014 11 21 1121-(2)

CTD 2003 7 1

CTD

3

ICH

1998 8 11739

1998 811 672 1999 14 Q&A 2004 2 25

2006 10 5

PMDA

2007 9 280928010

2012 9 5

2014 10 27

2018 - 54 -

1999 2 1 4104

1998 3 18256 265

CTD3 3 4 4

5 5

3.1 1)

2001 5 1 568 ICH-Q6A

2001 5 1571 ICH-Q6B

ICHICH-Q6A ICH-Q6B

ICH

2009 5 260526001 ICH-Q4B

ICH

6

1998 3 111-(5)

2)

2001 5 1 565

2018 - 55 -

ICH

2003 6 3 0603001ICH-Q1A(R2)

19975 28 422 ICH-Q1B

1997 5 28 425ICH-Q1C

1998 1 66 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)

2010 5 27 0527-(1)

2010 6 40604-(1)

4) GLP

1997 326 21 2008 6 13

114 GLP

2001 6 21 902

GLPGLP

20086 13 0613007

8 19

2018 - 56 -

1 1-4

2 5-8

3 9 10

4 11 12

5 13 14

6 15 16

7 17 18

8 19

GLPGLP

PMDA GLP

GLP

PMDA GLP PMDAGLP GLP

2008 6 200620058 2008 8 15

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GLP

PMDA GLP

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GLPGLP

GLP

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

5)

8

ICH2001 6 21

902 ICH-S7AGLP

1991 1 29 42001 6

21 902

2018 - 57 -

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

5.

GCP ICH

1997 3 2728 2016 1 229 GCP GCP

2018 - 58 -

2013 7 1

2)2.1

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

(ii)

2.2)

2008 7 9GMP 0709002

GMP Q&A2009 7 2

2.3) 4 I

IV3 ICH

1998 4 21380 ICH-E8

4

5

11

11 2

2018 - 59 -

4

(i) I

I

II

2001 6 1796

2012 4 2 0402-(1)

(ii) II

II

II

III

IIII III

(iii) III

IIIIII

II

1981 7

4 2005 11 1

(iv) IV

2.4)

2.5)

(i)

(ii)

2018 - 60 -

(iii)

(iv)

In vitro in vivo1/100

GCP

2008 6 3 0603001

3)

3.1)

3.2)

3.3)

GCP

3.4)

3.5)

1996 5 1335 ICH-E3

4)

1992 3 4 20

2018 - 61 -

199811 30 1047 ICH-E9 ICH

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

28 1 220122-(7)

2018 - 62 -

7) GMPGCP 17 “ ”

1997 3 31 480

GMP 2008 79 0709002

GMP

GMP Q&A2009 7 2

GMP GCP

GMP

GMP

GMP2001 11 2 1200

ICH-Q7A ICH-Q7 GMP

GMP 2000 11ICH 5

20

PIC/SGMP

2012 2 1

GMPGMP

2009 3 30GMP

2009 3 300330023 GMP

44.1

DNADNA

1986 12 11 1051

2018 - 63 -

1987 5 21 434 1995 8 18769

GILSP Good Industrial Large Scale Practice 1

2 3 4

2003 6 18 97

2004 1 291

2006 6 62 2004 2 19

DNA

1984 3 30 243

1988 6 6 1 10

2017 7 5 0705-(5)

ICH

12

3-xx

4.2

200012 1

2000 12 1

2000 12 26 1314

26.4 BSE

2002 7 31

2003 5

15 2102013

BSE

26 375

4.3

2009 3 4

2018 - 64 -

0304007

ICH Q5E

Q&A2009 7 21 2010 3

31 2015 12 15

2009 3 4 03040079

2012 4 26 0426-(2)2013 4 1

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)

PMDAHP

http://www.pmda.go.jp/PmdaSearch/iyakuSearch/ HP

2005 1 6IFPMA PhRMA

EFPIAJPMA

1

UMIN (UMIN-CTR;

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

http://www.japic.or.jp/index.html

2008 10 11001013 2009 4 2

4.5 ICHICH

1990 4

2018 - 65 -

6 ICHEU EFPIA MHLW JPMA FDA

PhRMA Swissmedic Health CanadaWHO IFPMA

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27 10ICH

ICH 5

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6 ICH 70

34 5

ICH ICH HP

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

HP http://www.ich.org/home.html

2018 - 66 -

PMS

8

PMDA

GMP

PMDA

GVP GPSP PMDA

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PMDA

GCP1. 2. 3.

2018 - 67 -

26 12

2535

31 85 83 96

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2575

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2018 - 68 -

26 9

2512

12 34 30 31

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GMP

2575

1.6~1.9~2.0 4.2~4.4~5.60.2~0.3~0.7 1.1~1.3~1.5 0.8~0.8~1.1

2018 - 69 -

32014 11 21 1121 2 2-(1)

×

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2018 - 70 -

3(1)

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2018 - 71 -

42014 11 21 1121 2 2-(2)

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(1)

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2018 - 72 -

4(4)

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(7)

5

(8)

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1. 2. 3.

1. 2.

3.

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1. 2. 3. 4.

5. 6. 7.

2018 - 73 -

5

2018 - 74 -

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

0211-(1) 2011 2 21ICH-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-Q11DNA 1110 –(3)

2015 11 10ICH-M7

2018 - 75 -

7

881993 8 10

ICH-S4443

1996 7 2ICH-S3A

5441996 8 6

ICH-S1C551

1998 7 9ICH-S1C(R) S1C(R1)

3151997 14

ICH-S1A316

1997 4 14ICH-S5A/ICH-S5B

18342000 12 27ICH-S5B(M) S5(R2)

5481998 7 9

ICH-S1B1019

1998 11 13

18312000 12 27

0219-(4) 2010 2 19ICH-M3(M) M3(R2)

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

2018 - 76 -

0920-(2)2012 9 20

ICH-S2 (R1)1002-(5)

2012 10 2

0521-(1)2014 5 21

ICH-S10

8

41991 1 29

9022001 6 21

ICH-S7A813

2001 6 4

9

4961998 6 26

4421996 7 2

ICH-S3B

0711-(1)2013 7 11

Q&A 2013 7 110401-(1)

2014 4 1

Q&A 2014 4 1

8132001 6 4

2014 7 8

2018 - 77 -

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

2016 3 11

2016 3 11

11

11-(10)

1987 4 211-(22)1987 10 31

1(1)1988 1 5

1(7)1988 3 16

7431998 8 25

2010 8 3742

1999 4 152017 7 70707-(1)

01280012002 1 28

ICH-E12A ICH-E120325035

2004 3 250512001

2004 5 121101001

2018 - 78 -

2005 11 12005 11 2

02170012006 2 17

06280012006 6 28

0527-(5)2010 5 27

0709-(1)2010 7 9

2014 5 191116-(1)

2010 11 160329 -(18)

2011 3 290930-(1)

2011 9 301213-(1)

2011 12 130930-(1)

2015 9 300407-(1)

2016 4 72

1041993 12 2

ICH-E7 (2010 9 17Q&A

2010 9 17

4941994 7 25

ICH-E4592

1995 5 24ICH-E1

3351996 5 1

ICH-E3380

1998 4 21ICH-E8

6721998 8 11

ICH-E5 ICH-E5(R1)2004 2 25

Q&A 2006 10 5Q&A 2

10471998 11 30

2018 - 79 -

ICH-E91334

2000 12 15ICH-E11

1362001 2 27

ICH-E10 20014 10

06030012008 6 3

QT/QTc 1023-(1)2009 10 23

ICH-E14 2009 10 23Q&A 2012

7 3 Q&A2

0219-(4)2010 2 19

ICH-M3(R2) 2012 816 Q&A

311(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

2018 - 80 -

12

3292000 2 22

ICH-Q5ADNA 3

1998 1 6ICH-Q5B

) 61998 1 6

ICH-Q5C( ) 873

2000 7 14ICH-Q5D

) 04260012005 4 26

ICH-Q5E571

2001 5 1ICH-Q6B

0323-(1)2012 3 23

ICH-S6(R)0701-(4)

2013 7 1

0701-(7)2013 7 1

2018 - 81 -

11 Common Technical Document (CTD)

2018 - 82 -

12

2018 - 83 -

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

E2B(R2)E2B(R3)

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