三、申报资料项目表及说明
(一)中药、天然药物申报资料项目表
资料分类 |
资料项目 |
注册分类及资料项目要求 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
6。1 |
6。2 |
6。3 |
综述资料 |
1 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
2 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
3 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
4 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
5 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
6 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
药学资料 |
7 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
8 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
9 |
- |
+ |
+ |
- |
▲ |
▲ |
▲ |
▲ |
- |
- |
- |
10 |
- |
+ |
+ |
+ |
▲ |
▲ |
▲ |
▲ |
- |
- |
- |
11 |
- |
+ |
+ |
- |
▲ |
▲ |
▲ |
▲ |
- |
- |
- |
12 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
13 |
+ |
+ |
± |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
资料分类 |
资料项目 |
注册分类及资料项目要求 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
6。1 |
6。2 |
6。3 |
药学资料 |
14 |
+ |
+ |
± |
+ |
+ |
+ |
± |
± |
± |
± |
- |
15 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
17 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
18 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
药理毒理资料 |
19 |
+ |
+ |
* |
+ |
+ |
+ |
+ |
+ |
+ |
± |
- |
20 |
+ |
+ |
* |
+ |
+ |
± |
+ |
+ |
+ |
± |
- |
21 |
+ |
+ |
* |
+ |
+ |
± |
+ |
+ |
- |
- |
- |
22 |
+ |
+ |
* |
+ |
+ |
+ |
+ |
+ |
+ |
± |
- |
23 |
+ |
+ |
± |
+ |
+ |
+ |
+ |
+ |
+ |
± |
- |
24 |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
25 |
+ |
+ |
▲ |
+ |
* |
* |
* |
* |
* |
- |
- |
26 |
+ |
+ |
* |
* |
* |
* |
* |
* |
* |
- |
- |
27 |
* |
* |
* |
* |
* |
* |
* |
* |
* |
- |
- |
28 |
+ |
- |
* |
- |
- |
- |
- |
- |
- |
- |
- |
临床资料 |
29 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
30 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
* |
- |
31 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
* |
- |
32 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
* |
- |
33 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
* |
- |
(二)说明 1。“+”指必须报送的资料; 2。“-”指可以免报的资料; 3。“±”指可以用文献综述代替试验研究或按规定可减免试验研究的资料; 4。“▲”具有法定标准的中药材、天然药物可以不提供,否则必须提供资料; 5。“* ”按照申报资料项目说明和申报资料具体要求。
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