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Health Sciences Authority

Fees and turnaround time for CTGTP

Here is the list of fees and turnaround time to help you with your CTGTP transactions.

Last updated 4 September 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
(working days)

ABRIDGED evaluation route



Screening of each NDA

$600

50

Evaluation of each NDA:


180

  • NDA-1 or NDA-2

$13,900

  • NDA-3

$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.

Annual registration retention per registered CTGTP

$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
(per consultation, up to one hour)

$210

Change of registrant (CTGTP)

$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
(working days)

ABRIDGED evaluation route



Screening of each MAV-1

$550

50

Evaluation of each MAV-1:


180

  • for the first strength

$7,900

  • for each subsequent strength 

$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
(working days)

MIV-1 application

$2,730

120

MIV-2 application
- Notification

$400

40 

 MIV-2 application
- Do-and-Tell

$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 for CTGTP dealer's notices

New Dealer's Notice for CTGTP

Fees

Importer

$95

Wholesaler

$95

Manufacturer

$95

Note: No fees are applicable for updates to a dealer’s notice.

Turnaround time (TAT)

  • TAT is 10 working days from application date.

  • TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

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):

  • For export only.

  • For scientific education, research and development, or non-clinical purpose.

$220
annual licence for multiple consignments

$116
licence for single consignment only (6-month validity)

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):

  • For export only.

  • For scientific education, research and development, or non-clinical purpose.

$220
annual licence for multiple consignments

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)

  • TAT is 10 working days from the date of technical assessment completion or inspection close out.

  • For applications which do not require technical assessment or inspection, TAT is 10 working days from application date.

  • TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Licence validity

  • 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:


  • Without technical assessment

$189

  • With technical assessment

$5,300

Manufacturer's licence (secondary packaging only):


  • Without technical assessment

$189

  • With technical assessment

$2,840

Turnaround time (TAT)

  • TAT is 10 working days from the date of technical assessment completion or inspection close out.

  • For applications which do not require technical assessment or inspection, TAT is 10 working days from application date.

  • TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Licence validity

  • 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 
(for overseas CTGTP manufacturer)

$650

GMP on-site inspection of an overseas CTGTP manufacturer 

$31,700

 *All fees stated above are chargeable per manufacturing site

Good Manufacturing Practice and Good Distribution Practice Certificates

Local dealers may voluntarily apply for the following certificates subject to compliance with the relevant standards:

List of application fees for various certificate types

Application type

Fees

Good Manufacturing Practice (GMP) certificate (with technical assessment)

$22,200

Good Manufacturing Practice (GMP) certificate (without technical assessment)

$220

Good Distribution Practice (GDP) certificate (with technical assessment)

$3,890

Good Distribution Practice (GDP) certificate (without technical assessment)

$220

Turnaround time (TAT)

  • TAT is 10 working days from the date of technical assessment completion or inspection closeout.

  • For applications which do not require technical assessment or inspection, TAT is 10 working days from application date.

  • TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

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

Other local dealer's certificates (CPP or FSC)

Local dealers may voluntarily apply for the following certificates subject to compliance with the relevant standards:

List of application fees for various certificate types

Application type

Fees

Application for a CPP

$116

Application for a FSC

$116

Turnaround time (TAT)

  • TAT is 10 working days from application date.

  • TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").