Fees and turnaround time for therapeutic products

Here is the list of fees and turnaround times to help you with your therapeutic product transactions.

New Drug Application (NDA) for product registration

NDA fees and turnaround time (TAT)

New Drug Application (NDA)
Click here for description of application types		 Fees TAT (in working days)
ABRIDGED evaluation route    
Screening $ 610 50
Evaluation:   180
  • NDA-1 or NDA-2
 $ 11,600
  • NDA-3
 $ 6,030
VERIFICATION evaluation route    
Screening  $ 610 50
Evaluation:   60
  • NDA-1 or NDA-2
 $ 17,100
  • NDA-3
 $ 6,030
FULL evaluation route    
Screening* $ 3,060 50
Evaluation* $ 83,100 270
*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

Generic Drug Application (GDA) for product registration

GDA fees and turnaround time (TAT)

Generic Drug Application (GDA)
Click here for description of application types		 Fees TAT (in working days)
ABRIDGED evaluation route    
Screening $ 610 50
Evaluation:   240
  • GDA-1
$ 4,280
  • GDA-2
 $ 2,450
VERIFICATION evaluation route    
Screening $ 610 50
Evaluation:   120
  • GDA-1
$10,600
  • GDA-2
 $ 5,500
VERIFICATION (CECA Scheme) evaluation route    
Screening $ 610 50
Evaluation:   90*
  • GDA-1
 $10,600
  • GDA-2
 $ 5,500
*HSA will issue the first communication to applicants within 14 working days from the date of acceptance for evaluation
Annual registration retention per registered product
 $ 330 NA

Biosimilar product registration

Biosimilar fees and turnaround time (TAT)

New Drug Application (NDA)
Click here for description of application types		 Fees TAT (in working days)
ABRIDGED evaluation route    
Screening $ 610 50
Evaluation:   180
  • NDA-2
 $ 11,600
  • NDA-3
 $ 6,030
VERIFICATION evaluation route    
Screening  $ 610 50
Evaluation:   60
  • NDA-2
 $ 17,100
  • NDA-3
 $ 6,030
Annual registration retention per registered product $ 330 NA

Major variation application

Major variation application (MAV-1)

Major Variation Application (MAV-1) Fees TAT (in working days)
ABRIDGED evaluation route    
Screening $    560 50
Evaluation:   180
  • for the first strength
 $ 6,030
  • for each subsequent strength 
 $ 3,060
VERIFICATION evaluation route    
Screening $    560 50
Evaluation:   60
  • for the first strength
 $ 8,850
  • for each subsequent strength
 $ 3,060
FULL evaluation route    
Screening* $ 2,780 50
Evaluation* $ 51,600 270
*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.

MAV-2 Product reclassification

There are no screening and evaluation fees for product reclassification applications. 

Product reclassification application (MAV-2) Fees TAT (in working days)
Screening  NIL 50
Evaluation  NIL 180

Minor variation application (MIV)

MIV-1 applications

MIV-1 applications Fees TAT (in working days)
ABRIDGED evaluation route  $  610 120
VERIFICATION evaluation route  $  610 90

Note: Fees are payable upon application submission. Turnaround time begins from the date of receipt of application dossier.

MIV-2 applications (Notification or Do-and-Tell)

There are no fees for MIV-2 applications.

MIV-2 (Notification) changes can be implemented 40 working days after application submission, if there are no objections from us.

MIV-2 (Do-and-Tell) applications do not require prior approval but must be submitted to us within 6 months of the implementation of changes.

Importer and wholesaler's licences

Importer and wholesaler's licence for therapeutic products

Importer and wholesaler's licence Fees
NEW application for importer's and wholesaler's licence
Import of any therapeutic product (full scope) $    560
Import of any therapeutic product under the following restricted activities only (limited scope):
  • For supply to a ship or an aircraft leaving Singapore.
  • For export only.
  • For non-clinical purpose.
 $    220
annual licence for multiple consignments
$   111
licence for single consignment only
Wholesale of any therapeutic product $    560
Bundled fee for importer's licence (full scope) and wholesaler's licence  $  1,000
RENEWAL of importer's and wholesaler's licence
Import of any therapeutic product (full scope) $    560
Import of any therapeutic product under the following restricted activities only (limited scope):
  • For supply to a ship or an aircraft leaving Singapore.
  • For export only.
  • For non-clinical purpose.
 $    220
annual licence for multiple consignments
Wholesale of any therapeutic product $    560
Bundled fee for importer's licence (full scope) and wholesaler's licence  $  1,000
AMENDMENT application for importer's and wholesaler's licence
Without site inspection (administrative amendment)  $     57
With site inspection $   330

Manufacturer's licence

Manufacturer's licence for therapeutic products

Manufacturer's licence Fees
NEW application for manufacturer's licence  
Manufacture of external preparations only (non-sterile) $ 1,670
Manufacture of oral preparations only (non-sterile) $ 1,670
Manufacture of external and oral preparations only (non-sterile) $ 2,230
Manufacture of sterile preparations, or other types of dosage forms or dosage form combinations not described in the options above $ 3,340
Primary packaging (with/without secondary packaging) $ 1,110
Secondary packaging only
 $    660
RENEWAL of manufacturer's licence  
Manufacture of external preparations only (non-sterile) $ 1,670
Manufacture of oral preparations only (non-sterile) $ 1,670
Manufacture of external and oral preparations only (non-sterile) $ 2,230
Manufacture of sterile preparations, or other types of dosage forms or dosage form combinations not described in the options above $ 3,340
Primary packaging (with/without secondary packaging) $ 1,110
Secondary packaging only
 $    660
AMENDMENT application for manufacturer's licence  
Without site inspection  $      57
With site inspection for a manufacturer carrying out packaging only $    560
With site inspection for all other manufacturers
 $ 1,110

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
GMP evidence evaluation $    660
Quality System Dossier (QSD) evaluation $ 4,970
On-site GMP audit of a manufacturing site located in:  
  •  an ASEAN country
  $ 18,600
  •  in an Asian country (outside of ASEAN)
  $ 20,600
  •  a country outside of Asia
  $ 24,600
 *All fees stated above are chargeable per manufacturing site

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

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

Certificates for local dealers  Fees TAT (in working days)
Good Manufacturing Practice (GMP) certificate for local manufacturers
Application for a GMP certificate $6,570 10 working days
from audit close out date
Each additional GMP certificate not requiring further assessment $220
Good Distribution Practice (GDP) certificate local importers and wholesalers
Application for a GDP certificate $3,900 10 working days
from audit close out date
Each additional GDP certificate not requiring further assessment $   220
Certificate of Pharmaceutical Products (CPP) or Statement of Licensing Status (SLS)
Application for a CPP $  111 10 working days
from application date
Application for a SLS $  111

Pharmacy licence

Pharmacy licence

Pharmacy licence Fees
Application for a new pharmacy licence $ 560
Application for the approval under regulations 3(1)(b)(ii) or 4(1)(b)*, if made on a separate occasion from an application for a pharmacy licence of that same retail pharmacy $ 330
Renewal of a pharmacy licence (annual) $ 560
Amend a pharmacy licence:
  • With site inspection
 $ 330
  • Without site inspection
 $   57

*Refers to the Health Products (Licensing of Retail Pharmacies) Regulations 2016, where:

  • Regulation 3(1)(b)(ii) refers to the supply by retail sale of any specified health products via special mode (e.g. secured box for self-collection)
  • Regulation 4(1)(b) refers to telepharmacy services

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