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|
(一)治療用生物製品申報資料專案表(資料專案1~15,29~38)
|
資料分類
|
資
料
項
目
|
註冊分類及資料專案要求
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
13
|
14
|
15
|
|
綜述資料
|
1
|
+
|
+
|
參照相應指導原則
|
參照相應指導原則
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
2
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
3
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
4
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
5
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
6
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
藥學研究資料
|
7
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
-
|
+
|
-
|
+
|
|
8
|
+
|
+
|
+
|
-
|
+
|
+
|
+
|
+
|
+
|
-
|
-
|
-
|
+
|
|
9
|
+
|
+
|
+
|
-
|
+
|
+
|
+
|
+
|
+
|
-
|
-
|
-
|
+
|
|
10
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
-
|
+
|
-
|
+
|
|
11
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
-
|
+
|
-
|
+
|
|
12
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
-
|
+
|
-
|
+
|
|
13
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
-
|
+
|
-
|
+
|
|
14
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
-
|
+
|
-
|
+
|
|
15
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
-
|
+
|
-
|
+
|
|
臨床研究資料
|
29
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
30
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
31
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
32
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
33
|
+
|
+
|
+
|
| | | |