Fees and turnaround time for CTGTP

Here is the list of fees and turnaround time to help you with your cell, tissue and gene therapy products (CTGTP) transactions.

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

Click for application types and evaluation routes descriptions.

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 retention fee:   $330 per product

Fees for other applications or procedures

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
Special Access Routes (SAR): 
$      240
$      270

Major variation application (MAV-1)

Fees and turnaround time for MAV-1 applications

Click for submission guide for MAV-1 applications.

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.

Minor variation applications (MIV)

Fees and turnaround time for MIV applications

Click for submission guide for MIV applications.

Minor variation applications  Fees TAT
(working days)

MIV-1 application

 $ 2,730 120

MIV-2 application

 $ 400 40   

Dealer's notice

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

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.

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
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

Manufacturer's licence

Manufacturer's licence

All manufacturers are required to hold valid manufacturer’s licence to manufacture a CTGTP which is not minimally manipulated.

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

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.

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

Other local dealer's certificates (GMP, GDP, CPP or FSC)

Other local CTGTP dealer's certificates (GMP, GDP, CPP or FSC)

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

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
from audit close out date
GMP certificate (without technical assessment) $     220
Good Distribution Practice (GDP) certificate
Application for a GDP certificate (with technical assessment) $  3,890 10 working days
from audit close out date
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
from application date
Application for a FSC $     116