Medicinal Product / Drug Trials
Type of Application | Target Processing Timeline (working days, excluding stop-clock time) | |
1 | Application for Clinical Trial Certificate (CTC) | 30 |
Phase 1 clinical trials (solely to evaluate bioequivalence, bioavailability, food effect or drug-drug interaction) | 15 | |
2 | Extension of Clinical Trial | 10 |
3 | Application for Import of Clinical Trial Materials (CTM) | |
a) In conjunction with Application for CTC or Extension of Clinical Trial | As per (1) or (2) | |
b) Subsequent application for approved clinical trial | 3 | |
4 | Amendment of Protocol and/or Patient Informed Consent Form | 15 |
5 | Addition of Trial Site | 10 |
6 | Change of Principal Investigator | 10 |
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Import of Unregistered Medical Devices for Clinical Trials
Type of Application | Target Processing Timeline (working days, excluding stop-clock time) | |
1 | Application for Import of Clinical Trial Materials (Medical Devices) (CTM-MD) | 5 |
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(With effect from 1 April 2011)
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