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 product 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 (NDA)

NDA types

There are three application types to register a Class 2 CTGTP:

Application Type Conditions
NDA-1 For the first strength of a product containing a new CTGTP. This means the CTGTP is currently not registered in Singapore.
NDA-2

(a)  For the first strength of a product containing:

  • New combination of registered CTGTP.
  • Registered CTGTP in either of the following:
    • New dosage form, such as capsules and injectables.
    • New presentation, such as single-dose vials, multi-dose vials and pre-filled syringes.
    • New formulation, such as preservative-free.
  • Registered CTGTP for use by a new route of administration.

(b)  For products that do not fall under the requirements for NDA-1 or NDA-3.
NDA-3 For subsequent strengths of a product that has been registered or submitted as a NDA-1 or NDA-2. The product name, dosage form, indication, dosing regimen and patient population should be the same as that for the NDA-1 or NDA-2 submission.

Fees and turnaround time (TAT)

New Drug Application (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 product
  $     330  NA

Fees for other applications or procedures

Applications or procedures  Fees
Pre-market consultation for CTGTP registration (per consultation, up to one hour) $      210
Change a registrant of a CTGTP $      158
Overseas Good Clinical Practice (GCP) inspection $ 11,400
Special Access Routes (SAR): 
$      240
$      270

Major variation application (MAV-1)

Major variation application (MAV-1)

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)

MIV-1 and MIV-2 applications

Applicants will receive an “Acceptance” notification sent to you within 3 working days after your submission of the MIV application via FORMSG.

  • Fees are payable upon submission of the MIV application via FORMSG.
  • The target processing timeline for the MIV-1 application is 120 working days. The target processing timeline starts from the date of receipt of the MIV-1 application in FORMSG to the date of regulatory decision or withdrawal date, excluding stop-clock time.
  • The MIV-2 changes may be implemented 40 days after application submission if there are no objections raised by HSA.
Minor variation applications (MIV-1 or MIV-2) Fees
MIV-1 application $ 2,730
MIV-2 application $    400

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