| SUBMISSIONS & APPROVALS |
MALAYSIA |
UK |
INDIA |
| Timelines |
2 months |
1-2 months |
3 months |
| Electronic Submission |
√ |
× |
× |
| Website Tracking |
√ |
× |
× |
| Parallel Submission to Ethics Committee |
√ |
√ |
√ |
| DOCUMENTATION |
MALAYSIA |
UK |
INDIA |
| List / details / undertaking of the investigators |
√ |
√ |
√ |
| Synopsis of the Protocol |
√ |
√ |
√ |
| Affidavit in support of Investigator’s Brochure |
× |
√ |
√ |
| Regulatory / IRB approvals of other countries |
√ |
√ |
√ |
| Pre-clinical data |
√ |
√ |
√ |
| Patent information (if applicable) |
√ |
√ |
√ |
| Dissolution/stability study data |
√ |
√ |
√ |
| Chemical information of the drug |
√ |
√ |
√ |
| Finance; facilities and staff relation information |
√ |
√ |
√ |