Fees and turnaround time for therapeutic products

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

Product registration for new drug application

Application types

NDA-1

First strength of a product containing a new chemical or biological entity.

NDA-2

  • First strength of a product containing one or more of the following chemical or biological entities which has been used as an active ingredient in a registered product:
    • A new combination.
    • A new dosage.
    • A new route of administration.
    • A new indication, dosage recommendation or patient population.
  • 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 an NDA-1 or NDA-2.

Fees

  • Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation.
  • All fees for the abridged or verification evaluation route are charged per NDA application submitted.
  • 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.
Application type Screening fee   Evaluation fee NDA-1 Evaluation fee NDA-2 Evaluation fee NDA-3
Verification evaluation route $565   $16,700
$16,700
$5,665
Abridged evaluation route $565   $11,200 $11,200 $5,665
Full evaluation route $2,830 $82,700 $82,700 $82,700

Annual retention fee (per registered product) : $309

Turnaround time

Application type Screening (in working days) Evaluation (in working days)
Verification evaluation route 50 60
Abridged evaluation route 50 180
Full evaluation route 50 270

Note:

  • Screening turnaround time begins from the date of receipt of application dossier.
  • Evaluation turnaround time begins from the date of acceptance for evaluation.
  • Turnaround time may be extended if your response to our queries is incomplete, and you are required to provide further clarification or additional information.

Payment modes

Product registration for generic drug application

Application types

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.

Fees

  • Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation.
  • All fees are charged per GDA application submitted.
Application type Screening fee  Evaluation fee GDA-1 Evaluation fee GDA-2
  • Verification evaluation route
  • Verification evaluation route (CECA scheme)
$565   $10,200 $5,150
Abridged evaluation route $565   $3,965 $2,265

Annual retention fee (per registered product) : $309

Turnaround time

Application type Screening (in working days) First communication (in working days) Evaluation (in working days)
Verification evaluation route 50 N.A. 120
Verification evaluation route (CECA scheme) 50 14 90
Abridged evaluation route 50 N.A. 240

Note:

  • Screening turnaround time begins from the date of receipt of application dossier.
  • Evaluation turnaround time begins from the date of acceptance for evaluation.
  • Turnaround time may be extended if your response to our queries is incomplete, and you are required to provide further clarification or additional information.

Payment modes

Product registration for biosimilar product

Application types

NDA-2

For the first strength of a biosimilar product with the same dosage form and route of administration as the Singapore reference biological product.

NDA-3

For subsequent strengths of a biosimilar product that has been registered or submitted as an NDA-2. The product name, dosage form, indication, dosing regimen and patient population should be the same as that for the NDA-2.

Fees

  • Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation.
  • All fees are charged per NDA application submitted.
Application type  Screening fee Evaluation fee NDA-2 Evaluation fee NDA-3
Biosimilar product application  $565 $11,200 $5,665
Annual retention fee (per registered product) : $309

Turnaround time

Application type Turnaround time for all applications (in working days)
Screening 50
Biosimilar product application 180

Note:

  • Screening turnaround time begins from the date of receipt of application dossier.
  • Evaluation turnaround time begins from the date of acceptance for evaluation.
  • Turnaround time may be extended if your response to our queries is incomplete, and you are required to provide further clarification or additional information.

Payment modes

Post-approval variation application

Major variation application (MAV-1)

Fees and turnaround time  Full evaluation Abridged evaluation Verification evaluation
Screening fee (payable upon application submission) $2,575 $515 $515
Evaluation fee (payable upon acceptance of application for first strength) $51,200 $5,665 $8,450
Evaluation fee (payable upon acceptance of application for subsequent strengths) N.A. $2,830 $2,830
Screening turnaround time (in working days) 50 50 50
Evaluation turnaround time (in working days) 270 180 60

Note:

  • Fees for full evaluation route are charged per submission package containing one or more MAV-1 for a product or product line.
  • Screening turnaround time begins from the date of receipt of application dossier.
  • Evaluation turnaround time begins from the date of acceptance for evaluation.
  • Turnaround time may be extended if your response to our queries is incomplete, and you are required to provide further clarification or additional information.

Minor variation application (MIV-1)


Abridged evaluation Verification evaluation
Submission fee $565 $565
Turnaround time (in working days) 120 90

Note:

  • Turnaround time begins from the date of receipt of application dossier.
  • Turnaround time may be extended if your response to our queries is incomplete, and you are required to provide further clarification or additional information.

MIV-2 application (Notification and Do-and-tell)

There are no fees for MIV-2 applications.

Product reclassification (MAV-2)

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

Turnaround time 

Screening Evaluation 
50  180

Payment 

Dealer's licence application

Importer and wholesaler's licences

Application for a new licence

Importer and wholesaler's licence Fee
Import of any therapeutic product (full scope) $515
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.
  • $206 (annual licence for multiple consignments)
  • $103 (licence per consignment only)
Wholesale of any therapeutic product $515
Bundled fee for importer's licence (full scope) and wholesaler's licence $925

Note:

  • Licences are valid for 12 months from the date of licence approval unless otherwise stated. Renewal of licences must be submitted and processed before the expiry.
  • Turnaround time is 10 working days from the date of audit close out.
  • Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Renewal fees

Licence Fee
Importer's licence (full scope) $515
Importer's licence for the following restricted activities only (limited scope):
  • For supply to a ship or an aircraft leaving Singapore.
  • For export only.
  • For non-clinical purpose.
$206
Wholesaler's licence $515
Bundled renewal fee of the importer's licence (full scope) and the wholesaler's licence $925

 

Amendment fees

Amendment Fee
Amend an importer's licence (full scope) or wholesaler's licence with site inspection $309
Amend an importer's licence or wholesaler's licence without site inspection $52

Note:

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

Manufacturer's licences

Application for a new licence 

Manufacturer's licence Fee
Manufacture of external preparations only (non-sterile) $1,545
Manufacture of oral preparations only (non-sterile) $1,545
Manufacture of external and oral preparations only (non-sterile) $2,060
Manufacture of sterile preparations, or other types of dosage forms or dosage form combinations not described above $3,090
Primary packaging only (with or without secondary packaging) $1,030
Secondary packaging only $615

Note:

  • Licences are valid for 12 months from the date of licence approval. Renewal of licences must be submitted and processed before the expiry.
  • Turnaround time is 10 working days from the date of audit close out.
  • Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Renewal fees

Licence Fee
Manufacture of external preparations only (non-sterile) $1,545
Manufacture of oral preparations only (non-sterile) $1,545
Manufacture of external and oral preparations only (non-sterile) $2,060
Manufacture of sterile preparations, or other types of dosage forms or dosage form combinations not described in the options above $3,090
Primary packaging only (with our without secondary packaging) $1,030
Secondary packaging only $615

 

Amendment fees

Amendment Fee
Amend a manufacturer's licence with site inspection for a manufacturer carrying out packaging only $515
Amend a manufacturer's licence with site inspection for all other manufacturers $1,030
Amend a manufacturer's licence without site inspection $52

Note:

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

Payment modes

Good Manufacturing Practice and Good Distribution Practice certificates

Fees

Application type Fee
Good Manufacturing Practice (GMP) certificate (valid for 3 years)
$6,180
Each additional GMP certificate not requiring further assessment
$206
Good Distribution Practice (GDP) certificate (valid for 3 years) $3,605
Each additional GDP certificate not requiring further assessment $206

Turnaround time

Turnaround time is 10 working days from the date of audit close out.

Note: Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Payment modes

GMP Conformity Assessment of overseas manufacturers of therapeutic products

Fees

Assessment types Fee (per manufacturing site)
GMP evidence evaluation $615
Quality System Dossier (QSD) evaluation $4,635
On-site GMP audit of a manufacturer located in an ASEAN country $18,200
On-site GMP audit of a manufacturer located in an Asian country (outside of ASEAN) $20,200
On-site GMP audit of a manufacturer located in a country outside of Asia $24,200

Payment modes

Retail pharmacy licence

Fees

Application type Fee
Application for a new retail pharmacy licence $515
Annual licence renewal fee
$515
Application fee for the authority’s approval under Regulation 3(1)(b)(ii) or 4(1)(b) in respect of a retail pharmacy if made on a separate occasion from an application for a pharmacy licence in respect of that same retail pharmacy $309
Amend retail pharmacy licence with site inspection $309
Amend retail pharmacy licence without site inspection $52

Note:

  • Regulation 3(1)(b)(ii) indicates the supply by retail sale of any specified health products via special mode (e.g. secured box for self-collection).
  • Regulation 4(1)(b) is for the regulation of telepharmacy services.
  • Turnaround time is 10 working days from the date of audit close out.
  • Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Payment modes

Certificate of a Pharmaceutical Product and Statement of Licensing Status

Fee

The application fee is $103.

Turnaround time

Turnaround time is 10 working days from the date of application.

Note: Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Validity

  • 24 months from the date of issuance of the Statement of Licensing Status.
  • 6 or 24 months from the date of issuance of the Certificate of a Pharmaceutical Product, depending on the product type.

Payment modes

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