Product registration for biosimilar product
Application types
NDA-2
For the first strength of a biosimilar product with the same dosage form, route of administration and presentation as the Singapore reference biological product.
NDA-3
For subsequent strengths of a biosimilar product that has been registered or submitted as an NDA-2. The product name, dosage form, presentation, indication, dosing regimen and patient population should be the same as that for the NDA-2.
Fees
- Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation.
- All fees are charged per NDA application submitted.
Application type |
Screening fee |
Evaluation fee NDA-2 |
Evaluation fee NDA-3 |
Verification evaluation route |
$580 |
$16,900 |
$5,830 |
Abridged evaluation route
|
$580
|
$11,400 |
$5,830 |
Annual retention fee (per registered product) : $318
Turnaround time
Application type |
Screening (in working days) |
Evaluation (in working days) |
Verification evaluation route |
50 |
60 |
Abridged evaluation route |
50 |
180 |
Note:
- Screening turnaround time begins from the date of receipt of application dossier.
- Evaluation turnaround time begins from the date of acceptance for evaluation.
- Turnaround time may be extended if your response to our queries is incomplete, and you are required to provide further clarification or additional information.
Payment modes