Fees and turnaround time for CTGTP
Here is the list of fees and turnaround time to help you with your CTGTP transactions.
Last updated 2 April 2026
Fees are payable via GIRO (apply eGIRO) or eNETS
Turnaround time (TAT) excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
Class 1 CTGTP notification
Fees: $95, payable at the point of application submission.
Turnaround time: The outcome of notification can be expected within 14 working days of your notification submission.
Class 2 CTGTP registration
Fees and turnaround time for NDA applications
Click for application types and evaluation routes descriptions.
List of fees and turnaround time
NDA for Class 2 CTGTP registration | Fees | TAT |
ABRIDGED evaluation route | ||
Screening of each NDA | $600 | 50 |
Evaluation of each NDA: | 180 | |
| $13,900 | |
| $5,900 | |
FULL evaluation route | ||
Screening of each NDA package (NDA-1, NDA-2 and NDA-3)* | $3,050 | 50 |
Evaluation of each NDA package (NDA-1, NDA-2 and NDA-3)* | $82,900 | 270 |
*All fees for full evaluation route are charged per NDA submission package which can contain one or more NDA to register the product or product line. | ||
$330 | N.A. | |
Notes:
Fees: Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation.
Turnaround time (TAT): Screening turnaround time begins from the date of receipt of application dossier. Evaluation turnaround time begins from the date of acceptance for evaluation.
Fees for other applications or procedures
List of fees
Applications or procedures | Fees |
Pre-market consultation for CTGTP registration | $210 |
$158 | |
Overseas Good Clinical Practice (GCP) inspection | $11,400 |
Major variation application (MAV-1)
Fees and turnaround time for MAV-1 applications
Click for submission guide for MAV-1 applications.
List of fees and turnaround time
Major Variation Application (MAV-1) | Fees | TAT |
ABRIDGED evaluation route | ||
Screening of each MAV-1 | $550 | 50 |
Evaluation of each MAV-1: | 180 | |
| $7,900 | |
| $3,050 | |
FULL evaluation route | ||
Screening of MAV-1 package* | $2,730 | 50 |
Evaluation of MAV-1 package* | $51,400 | 270 |
*All fees for full evaluation route are charged per MAV-1 submission package which can contain one or more MAV-1 for the product or product line. | ||
Notes:
Fees: Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation.
Turnaround time (TAT): Screening turnaround time begins from the date of receipt of application dossier. Evaluation turnaround time begins from the date of acceptance for evaluation.
Minor variation applications (MIV)
Fees and turnaround time for MIV applications
Click for submission guide for MIV applications.
List of fees and turnaround time
Minor variation applications | Fees | TAT | ||
MIV-1 application | $2,730 | 120 | ||
MIV-2 application | $400 | 40 | ||
MIV-2 application | $400 | -* | ||
* MIV-2 (Do-and-Tell) changes do not require prior approval from us before implementation but an MIV-2 application must be submitted to us within 6 months of the implementation of changes.
Dealer's notice
All dealers dealing in minimally manipulated CTGTP are required to notify HSA on their activities prior to commencing the import, manufacture or wholesale of the CTGTP.
Fees: The applicable fees for a new dealer’s notice submission is $95. No fees are applicable for changes to a dealer’s notice.
Importer's and wholesaler's licences
All dealers dealing in a CTGTP which is not minimally manipulated are required to hold valid importer's or wholesaler's licence to import or wholesale the CTGTP, respectively.
List of fees
Importer and wholesaler's licence for CTGTP | Fees |
NEW application for importer's and wholesaler's licence | |
Import of any CTGTP (full scope) | $1,470 |
Import of any CTGTP under the following restricted activities only (limited scope):
| $220 |
$116 | |
Wholesale of any CTGTP | $1,470 |
Bundled fee for importer's licence (full scope) and wholesaler's licence | $2,630 |
RENEWAL of importer's and wholesaler's licence | |
Import of any CTGTP (full scope) | $550 |
Import of any CTGTP under the following restricted activities only (limited scope):
| $220 |
Wholesale of any CTGTP | $550 |
Bundled fee for importer's licence (full scope) and wholesaler's licence | $990 |
AMENDMENT application for importer's and wholesaler's licence | |
Without technical assessment | $126 |
With technical assessment | $1,160 |
Turnaround time (TAT) and licence validity
TAT is 10 working days from the date of audit close out. The TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
Licences are valid for 12 months from the date of licence approval unless otherwise stated. Applications for renewal of licences must be submitted and processed before the licence expiry.
Manufacturer's licence
All manufacturers are required to hold valid manufacturer’s licence to manufacture a CTGTP which is not minimally manipulated.
List of fees
Manufacturer's licence for CTGTP | Fees |
NEW application for manufacturer's licence | |
Manufacturer's licence | $22,200 |
Manufacturer's licence (secondary packaging only) | $10,800 |
RENEWAL of manufacturer's licence | |
Manufacturer's licence | $13,600 |
Manufacturer's licence (secondary packaging only) | $3,780 |
AMENDMENT application for manufacturer's licence | |
Manufacturer's licence: | |
| $189 |
| $5,300 |
Manufacturer's licence (secondary packaging only): | |
| $189 |
| $2,840 |
Turnaround time (TAT) and licence validity
TAT is 10 working days from the date of audit close out. The TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
Licences are valid for 12 months from the date of licence approval unless otherwise stated. Applications for renewal of licences must be submitted and processed before the licence expiry.
GMP conformity assessment of overseas manufacturers
HSA may conduct a Good Manufacturing Practice (GMP) conformity assessment on overseas manufacturers as part of the product registration requirements.
List of fees
GMP conformity assessment types | Fees |
Verification of compliance with GMP standard | $650 |
GMP on-site inspection of an overseas CTGTP manufacturer | $31,700 |
*All fees stated above are chargeable per manufacturing site | |
Other local dealer's certificates (GMP, GDP, CPP or FSC)
Local dealers may voluntarily apply for the following certificates subject to compliance with the relevant standards:
Good Manufacturing Practice (GMP) certificate for local manufacturers
Good Distribution Practice certificate for local importers and wholesalers
Certificate of Pharmaceutical Product (CPP) and Certificate of Free Sale (FSC)
List of fees
Other certificates for local CTGTP dealers | Fees | TAT (working days) |
Good Manufacturing Practice (GMP) certificate for local manufacturers | ||
Application for a GMP certificate (with technical assessment) | $22,200 | 10 working days |
GMP certificate (without technical assessment) | $220 | |
Good Distribution Practice (GDP) certificate | ||
Application for a GDP certificate (with technical assessment) | $3,890 | 10 working days |
GDP certificate (without technical assessment) | $220 | |
Certificate of Pharmaceutical Products (CPP) or Certificate of Free Sale (FSC) | ||
Application for a CPP | $116 | 10 working days |
Application for a FSC | $116 | |
Special Access Routes
List of fees and turnaround time
Special Access Route (SAR) applications | Fees | TAT (working days) |
Import of an unregistered Class 2 CTGTP for named patient use | $240 | 14 |
Import of a registered CTGTP on a consignment basis (per consignment) | $270 |