2015/9/3

1

vs.

DMF

DMF

2

3

4

vs. -

()

Zaditen eye dropketotifen fumarate

Zaditen eye dropGlycerol,

5

vs. -

16

6

-

http://www.fda.gov.tw/TC/siteList.aspx?sid=2996

GOOD!

7

-

http://www.fda.gov.tw/TC/siteList.aspx?sid=2996

GOOD!

102/7/1 DMF

8

-

Drug Master File(DMF)

9

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

http://www.fda.gov.tw/TC/site.aspx?sid=2008

http://www.cde.org.tw/

(101127)

(101730)

6(98716)

16

~~

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/

16

17

--(101730)

(USP)()

18

Acetaminophen

Cefaclor

Cefazolin (Sodium)

Dextromethorphan HBr

Diclofenac Sodium

Gliclazide

Metformin HCl

Risperidone

Tamsulosin HCl

Valproic acid

19

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

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

((DMF))

()

(DMF)

(CDE)DMF

DMF

DMF

23

../(DMF)/DMF/.doc

(DMF)

DMF

DMF

DMF

(1) 1() (2)COA()

24

../(DMF)/DMF/.doc