《药品注册管理办法》(试行)附件三:生物制品注册分类及申报资料项目要求(2)
信息来源:中国药典2000年版一部附录 更新时间:2006-12-10 18:17:45
四、申报资料要求 (一)治疗用生物制品申报资料项目表(资料项目1~15,29~38)
|
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 |
10 |
11 |
12 |
13 |
14 |
15 |
|
综述资料 |
1 |
+ |
+ |
参照相应指导原则 |
参照相应指导原则 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
2 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
3 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
4 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
5 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
6 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
药学研究资料 |
7 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
+ |
- |
+ |
|
8 |
+ |
+ |
+ |
- |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
+ |
|
9 |
+ |
+ |
+ |
- |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
+ |
|
10 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
+ |
- |
+ |
|
11 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
+ |
- |
+ |
|
12 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
+ |
- |
+ |
|
13 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
+ |
- |
+ |
|
14 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
+ |
- |
+ |
|
15 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
+ |
- |
+ |
|
临床研究资料 |
29 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
30 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
31 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
32 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
33 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
其他 |
34 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
35 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
36 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
+ |
- |
+ |
|
37 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
+ |
- |
+ |
|
38 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
+ |
- |
+ | 注: 1.+:指必须报送的资料; 2.-:指可以免报的资料;
|
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