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This application is a service of the Singapore Government.

Health Sciences Authority

Fees

Application/Evaluation Fees for Therapeutic Products

Description of Application Types
Fees

Application Types

NDA-1: First strength of a product containing a new chemical or biological entity

NDA-2:

a)First strength of a product containing one or more chemical or biological entity(ies) which has been used as an active ingredient in a registered product:

i) A new combination; 
ii) A new dosage form/presentation/formulation;
iii) A new route of administration; or
iv) New indication, dosage recommendation and/or patient population

b) Products that do not fall under the requirements for NDA-1, NDA-3 or GDA

NDA-3: Subsequent strength of a product that has been registered or submitted as a NDA-1 or NDA-2

GDA-1: First strength of a generic chemical product

GDA-2: Subsequent strength of a product that has been registered or submitted as GDA-1

MAV-1: A variation to the indication(s), dosing regimen(s), patient population and/or inclusion of clinical information for extending the use of a registered product

MIV-1: A minor variation to the quality aspects, i.e chemistry, manufacturing and controls, and/or product labelling of a registered product. 

For more information on the application type (NDA 1/2/3, GDA 1/2, MAV, MIV) and evaluation routes (abridged/verification/full), please refer to the Guidance on Therapeutic Product Registration Nov 2016. 

 

Fees

(A) PRODUCT REGISTRATION

Registering a product – New Drug Application (NDA) & Generic Drug Application (GDA)
a) Screening (Payable upon submission)  
  (i) Abridged/Verification Dossier (NDA & GDA) $550
  (ii) Full Dossier (NDA)* $2,750
b) Evaluation (Payable upon acceptance)  
  (i) NDA Abridged Dossier (Chemical Drugs & Biologics)  
  - NDA-1 & NDA-2 $11,000
  - NDA-3 $5,500
  (ii) NDA Verification Dossier (Chemical Drugs & Biologics)  
  - NDA-1 & NDA-2 $16,500
  - NDA-3 $5,500
  (iii) NDA Full Dossier* $82,500
  (iv) GDA Abridged Dossier  
  - GDA-1 $3,850
  - GDA-2 $2,200
  (v) GDA Verification Dossier  
  - GDA-1 $10,000
  - GDA-2 $5,000
  (vi) GDA Verification Dossier (CECA Scheme)  
  - GDA-1 $10,000
  - GDA-2 $5,000
     
c) Annual retention fee $300

 

Amendment to a registered therapeutic product -Major Variation (MAV) and Minor Variation (MIV)

 
a) MAV-1 (Chemical Drugs & Biologics)  
  (i) Screening (Payable upon submission)  
  - Abridged/Verification Dossier $500
  - Full Dossier* $2,500
  (ii) Evaluation (Payable upon acceptance)  
  - Abridged Dossier  
 

- for first strength

$5,500
 

- for subsequent strength

$2,750
  - Verification Dossier  
 

- for first strength

$8,250
 

- for subsequent strength

$2,750
  - Full Dossier* $51,000
  * Fees will be charged based on per submission (regardless of the number of strengths and/or dosage forms).  
     
b) MIV-1 (Payable upon submission) $550
(B) CONSIGNMENT APPROVAL  
Application fee for approval to import registered therapeutic products under Health Products (Therapeutic Products) Regulation 2016 regulation 5(1)(b)(vii) $250