Fees and turnaround time for therapeutic products

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

Last updated 19 March 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").

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

Notes:

Fees: Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation. GIRO Progressive Payment Scheme is available for NDA submitted via full or abridged routes, and for all GDA (any route).
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.

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

Notes:

Fees: Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation. GIRO Progressive Payment Scheme is available for NDA submitted via full or abridged routes, and for all GDA (any route).
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.

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

Notes:

Fees: Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation. GIRO Progressive Payment Scheme is available for NDA submitted via full or abridged routes, and for all GDA (any route).
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.

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.

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.

MAV-2 Product reclassification

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

MAV-2 Product reclassification

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

Fees for Importer and wholesaler's licence

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 (6-month validity)
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

Turnaround time (TAT) and licence validity

TAT is 10 working days from the date of audit close out. The TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
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

Manufacturer's licence for therapeutic products

Fees for Manufacturer's licence

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

Turnaround time (TAT) and licence validity

TAT is 10 working days from the date of audit close out. The TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
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.

Fees for GMP conformity assessment types

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:

Fees for certificates for local dealers

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	10 working days from audit close out date
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	10 working days from audit close out date
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	10 working days from application date

Pharmacy licence

Pharmacy licence

Fees for 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

Turnaround time (TAT) and licence validity

TAT is 10 working days from the date of audit close out. The TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
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.

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Fees and turnaround time for therapeutic products

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