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(二)治療用生物製品藥理毒理研究資料專案要求(資料專案16~28)
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分類
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項目
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註冊分類及資料專案要求
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1
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2
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3
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4
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5
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6
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7
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8
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9
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10
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11
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12
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13
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14
|
15
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藥理毒理研究資料
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16
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+
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+
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參照相應指導原則
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參照相應指導原則
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+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
17
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
18
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
19
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
±
|
|
20
|
+
|
±
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
|
21
|
+
|
±
|
±
|
±
|
±
|
-
|
+
|
±
|
+
|
+
|
+
|
+
|
±
|
|
22
|
+
|
-
|
±
|
±
|
±
|
-
|
+
|
±
|
±
|
+
|
-
|
±
|
-
|
|
23
|
+
|
-
|
±
|
±
|
±
|
-
|
+
|
±
|
±
|
+
|
-
|
±
|
-
|
|
24
|
+
|
-
|
±
|
±
|
±
|
-
|
+
|
±
|
±
|
+
|
-
|
±
|
-
|
|
25
|
+
|
+
|
+
|
+
|
+
|
-
|
+
|
+
|
+
|
+
|
-
|
+
|
±
|
|
26
|
+
|
+
|
+
|
+
|
+
|
-
|
+
|
+
|
+
|
+
|
+
|
+
|
±
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|
27
|
-
|
-
|
-
|
+
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|
28
|
+
|
-
|
-
|
-
|
-
|
-
|
+
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-
|
-
|
±
|
-
|
-
|
-
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注:
1.+
:指必須報送的資料;
2.-:指可以免報的資料;
3.±:根據申報品種的具體情況要求或不要求。
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