原料藥許可證新風貌
Post on 14-Apr-2017
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2015/9/3
1
-
vs.
DMF
DMF
2
-
3
-
4
-
vs. -
()
Zaditen eye dropketotifen fumarate
Zaditen eye dropGlycerol,
5
-
vs. -
16
6
-
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http://www.fda.gov.tw/TC/siteList.aspx?sid=2996
GOOD!
7
-
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http://www.fda.gov.tw/TC/siteList.aspx?sid=2996
GOOD!
102/7/1 DMF
8
-
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Drug Master File(DMF)
9
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10
-
-
DMF
105/1/1DMF
98/9/16DMF
102/6/30103/6/30DMF
102/7/1+DMF
104/7/1DMF
12
-
-
DMF
DMF
(DMF)
DMF
13
-
DMF
()
DMF
()TFDADMF
14
-
DMF
DMF
15
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http://www.fda.gov.tw/TC/site.aspx?sid=2008
http://www.cde.org.tw/
(101127)
(101730)
6(98716)
16
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http://www.fda.gov.tw/TC/site.aspx?sid=2008http://www.fda.gov.tw/TC/site.aspx?sid=2008http://www.fda.gov.tw/TC/site.aspx?sid=2008http://www.cde.org.tw/http://www.cde.org.tw/
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16
17
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--(101730)
(USP)()
18
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Acetaminophen
Cefaclor
Cefazolin (Sodium)
Dextromethorphan HBr
Diclofenac Sodium
Gliclazide
Metformin HCl
Risperidone
Tamsulosin HCl
Valproic acid
19
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10273()1021231
103527
1041231
20
-
6()
2
(1)DMF0.5
(2)PIC/S GMPFDA/EMEA0.8
(3)(1)(2)0.9
(4)(1)(2)1.0
21
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PIC/S GMP
Pharmaceutical Inspection Convention and
Pharmaceutical Inspection Co-operation Scheme,
PIC/S()
GMP43
99
PIC/S GMP Part I(), Part II()
GMP
cGMP
cGMP
PIC/S GMP
1980s 1990s 2007.12~
International
Harmonization
22
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((DMF))
()
(DMF)
(CDE)DMF
DMF
DMF
23
../(DMF)/DMF/.doc
-
(DMF)
DMF
DMF
DMF
(1) 1() (2)COA()
24
../(DMF)/DMF/.doc
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