|
No. |
Our Promise |
Target |
Achieve Expectation |
Below Expectation |
Total |
||
|
Number |
Percentage |
Number |
Percentage |
||||
|
1. |
To evaluate application for registration of: |
||||||
|
Prescription Drugs |
210 working days |
123 |
73.65% |
44 |
26.35% |
167 |
|
|
Non-prescription Drugs |
210 working days |
31 |
100% |
0 |
- |
31 |
|
|
New Drugs and Biologicals |
245 working days |
93 |
98.9% |
1 |
1.06% |
94 |
|
|
2. |
To evaluate application for registration of traditional products containing: |
||||||
|
Single active ingredient |
116 working days |
164 |
85.8% |
27 |
15.5% |
191 |
|
|
2 or more active ingredients |
136 working days |
352 |
83.0% |
72 |
17.0% |
424 |
|
|
To evaluate application for registration of health supplements containing: |
|||||||
|
Single active ingredient |
116 working days |
78 |
100% |
0 |
- |
78 |
|
|
2 or more active ingredients |
136 working days |
158 |
98.75% |
2 |
1.25% |
160 |
|
|
3. |
To evaluate application for registration of non-prescription drugs (as stated in Table V Drug Registration Guidance Document) containing: |
||||||
|
Single active ingredient |
116 working days |
6 |
100% |
0 |
- |
6 |
|
|
2 or more active ingredients |
136 working days |
6 |
100% |
0 |
- |
6 |
|
|
4. |
Issuance of Cosmetic Notification |
1 working day |
63,821 |
100% |
0 |
- |
63,821 |
|
5. |
Certificate of Free Sale (CFS) for Cosmetics |
15 working days |
2,470 |
100% |
0 |
- |
2,470 |
|
6. |
Decision on application for change of registration holder |
45 working days |
333 |
100% |
0 |
- |
333 |
|
7. |
Certificate of Pharmaceutical Product (CPP) |
15 working days |
2,323 |
100% |
0 |
- |
2,323 |
|
8. |
Certificate of Free Sale (CFS) |
15 working days |
35 |
100% |
0 |
- |
35 |
|
7. |
Decision on application for change of manufacturing site |
60 working days |
490 |
88.9% |
61 |
11.1% |
551 |
|
9. |
Issuance of manufacturer's, wholesaler's and importer's license |
4 working days |
1,698 |
93.9% |
110 |
6.1% |
1,808 |
|
10. |
Evaluation of Import License Application for Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) : |
||||||
|
For products involving Phase 1 study, biological products, Cell & Gene Therapy Products (CGTPs) and herbal products |
45 working days |
58 |
100% |
0 |
- |
58 |
|
|
For products other than stated above |
30 working days |
129 |
100% |
0 |
- |
129 |
|
