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11-1470000-002510-14 49
(Good Review Practices)
2010. 9
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.
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2010. 8. 30
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GRP-SOP-2010-1 1
GRP-SOP-2010-2 11
GRP-SOP-2010-3 19
GRP-SOP-2010-4 49
GRP-SOP-2010-5 59
GRP-SOP-2010-6 77
GRP-SOP-2010-7 () 89
GRP-SOP-2010-8 125
GRP-SOP-2010-9 () 137
GRP-SOP-2010-10 161
GRP-SOP-2010-11 181
GRP-SOP-2010-12 257
GRP-SOP-2010-13 267
GRP-SOP-2010-14 307
GRP-SOP-2010-15 315
GRP-SOP-2010-16 327
GRP-SOP-2010-17 341
GRP-SOP-2010-18 351
GRP-SOP-2010-19 399
GRP-SOP-2010-20 425
GRP-SOP-2010-21 433
GRP-SOP-2010-22 445
GRP-SOP-2010-23 465
GRP-SOP-2010-24 499
GRP-SOP-2010-25 543
SOP number : GRP-SOP-2010-1
Version : 1.1
Date : 2010. 09. 01.
Standard Operating Procedure(SOP) for SOP
2010. 09. 01.
2
1 2008 GRP-SOP-2008-20 1.0
()
2 2010 GRP-SOP-2010-1 1.1
()
1
3
(Good Review Practice; GRP)
(Standard Operating Procedure; SOP) ,
.
(: 02-380-1703
~1705, : [email protected]) .
1.
1.1. (Good Review Practice, GRP)
1.2. (Standard Operating Procedure, SOP)
1.3. GRP
2.
2.1. ()
2.2.
2.3. ( 6)
3. SOP
3.1. SOP , , ,
4
3.2. SOP
3.3. SOP
3.4. SOP (Flow diagram)
4.
1.
1.1. (Good Review Practice, GRP)
, , ,
,
, .
1.2. (Standard Operating Procedure, SOP)
.
1.3. GRP
GRP ,
,
.
2.
2.1. ()
(1) SOP
.
(2) SOP , .
(3) SOP .
(4) SOP , , .
1
5
2.2.
(1) SOP .
(2) SOP SOP ,
.
(3) SOP
.
(4) SOP .
2.3. ( 6)
(1) SOP ,
SOP
.
(2) SOP SOP
.
(3) SOP ,
,
SOP (SOP
)
3. SOP
3.1. SOP , , ,
3.1.1. SOP .
SOP , ,
SOP SOP , .
3.1.2. SOP .
3.1.3. GRP SOP SOP
.
3.1.4. SOP
GRP .
6
3.1.5. SOP ,
. (15 ).
3.1.6. .
3.1.7. (15 ) ,
(hard copy) .
.
3.1.8. SOP , SOP
, .
3.1.9. SOP
. , .
3.1.10.
.
3.1.11. .
3.2. SOP
SOP . , SOP
.
GRP-SOP
Good Review Practice SOP
4
) GRP-SOP-2007-1
3.3. SOP
3.3.1. SOP , , GRP .
1
7
3.3.2.
SOP .
(1)
(2)
(3) (, , , () )
(4)
(5) ( )
(6) ( )
3.3.3.
(1) .
(2)
.
3.3.4.
(1) .(2)
., .(3) ,
.
3.3.5.
,
.
8
3.4. SOP (Flow diagram)
SOP/
-SOP /
-SOP ,
-SOP
-
-
-SOP (15 )-SOP
-SOP (hard copy)
-SOP -SOP , -
-SOP
()
-SOP , -GRP
-SOP (hard copy) SOP
-
--
-
SOP
- SOP (15 )
-SOP
?
?
NoYes
Yes
No
1
9
4.
SOP SOP
.
SOP number : GRP-SOP-2010-2
Version : 2.1
Date : 2010. 09. 01.
Review Responsibility Allotments in Drug Evaluation Department
2010. 09. 01.
12
1 2006 1-1 1.0
2 2007 GRP-SOP-2007-0 2.0
3 2010 GRP-SOP-2010-2 2.1
()
2
13
,
, , .
(: 02-380-1703
~5, : [email protected]) .
14
710 731 741 799
( ) ( )
110 120 190 210 220 264 , , , 799
( ) 800 () *
130
140 190 261 262
1. .
( 2009.8.24 196)
2. .
2
15
263 265 266 ( )269 410 420 430 490 610 620 640 739 799
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230 240 ( )250 267 (, , , )290 310 320 330 340 390 720 799
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SOP number : GRP-SOP-2010-3
Version : 1.4
Date : 2010. 09. 01.
Guidance on the Review Process of a New Drug Application
2010. 09. 01.
20
1 2006 1-3 1.0
2 2007 GRP-SOP-2007-1-1 1.3
3 2010 GRP-SOP-2010-3 1.4
()
3
21
( 238, 2009. 12. 22.)
()
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(: 02-380-1703
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1.
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1) GRP-SOP-2010-5 .
3
23
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GRP-SOP-2010-2
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2.2.
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24
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GRP-SOP-2010-5
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(GMP) ,
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(GMP)
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3.1. ()
3.1.1. ()
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+
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26
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85, 70.
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3.1.2.
.
.
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3.2.
3.2.1.
120 20
3.2.2.
60 45
3.2.3.
3
27
1. , ,
252,000 280,000
2. ,
. (, .)
189,000 210,000
. 126,000 140,000
. 38,000 43,000
3.
. ( ) 3,726,000 4,140,000
. 1,863,000 2,070,000
. 1,134,000 1,260,000
. 1) 5)
1) 1,935,000 2,150,000 2) 1,170,000 1,300,000
3) 1,449,000 1,610,000
4) 513,000 570,000
5) 306,000 340,000
. 207,000 230,000
4. ( 39 )
108,000 120,000
5.
. ( ) 2,097,000 2,330,000.
( )1,080,000 1,200,000
. 1) 4)
1) 513,000 570,000 2)
( )153,000
(1,170,000)170,000
(1,300,000)
3) 153,000 170,000 4) 207,000 230,000
3.2.4. ( , 2010-23, 2010.4.30)
28
6.
. 720,000 800,000 . 1) 3)
1) 306,000 340,000
2) 99,000 110,000
3) 207,000 230,000
7.
. ( ) 765,000 850,000
. 1) 4)
1) 153,000 170,000 2) 99,000 110,000 3)
(, 17 )
252,000 280,000
4) 207,000 230,000
8. 513,000 570,000
9. 252,000 280,000
10. 27,000 30,000
11. 14,000 15,000
12.
. ( 27 )
1,872,000 2,080,000
. 459,000 510,000 . 1) 4)
. 1) 1,035,000 1,150,000