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Fees and turnaround time for CTGTP

Here is the list of fees and turnaround times to help you with your cell, tissue and gene therapy products (CTGTP) transactions.

Class 1 CTGTP product notification

Fees: $90, 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)

Application 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

  • Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation.
  • All fees for the abridged 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.
Fees Abridged evaluation route Full evaluation route
Screening fee $570 $2,900
Evaluation fee for NDA-1 $13,700 $82,700
Evaluation fee for NDA-2 $13,700 $82,700
Evaluation fee for NDA-3 $5,700 $82,700

Annual retention fee (per registered product) : $310

Turnaround time

  • 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.
Turnaround time (in working days) Abridged evaluation route Full evaluation route
Screening 50 50
Evaluation 180 270

Fees for other applications or procedures

Applications or procedures  Fees
 Pre-market consultation for CTGTP registration $200 
 Change a registrant of a CTGTP $150 
 Overseas Good Clinical Practice (GCP) inspection $11,200
 SAR: import of an unregistered Class 2 CTGTP for named patient use $230 
 SAR: Import of a registered CTGTP on a consignment basis $260 per consignment 

Major variation application (MAV-1)

Fees

  • Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation.
  • All fees for the abridged evaluation route are charged per MAV-1 application submitted.
  • All fees for full evaluation route are charged per MAV-1 submission package which can contain one or more MAV-1 for a product or product line.
Fees Abridged evaluation Full evaluation
Screening fee $520 $2,600
Evaluation fee for first strength submitted $7,700 $51,200
Evaluation fee for subsequent strengths submitted $2,900 N.A

Turnaround time

  • 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.
Turnaround time (in working days) Abridged evaluation route Full evaluation route
Screening 50 50
Evaluation 180 270

Minor variation applications (MIV-1 and MIV-2)

Fees and turnaround time

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.
Fees and turnaround time MIV-1 MIV-2
Application fee $2,600 $380
Turnaround time (in working days) 120 40

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 and turnaround time

The applicable fees for a new dealer’s notice submission is $90. No fees are applicable for changes to a dealer’s notice.

The dealer must ensure that the details submitted are true and accurate.

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.

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.

New licence application

Licence type Fee
Importer's licence (full scope) $1,400
Importer's licence under the following activities only (limited scope):
  • For export only.
  • For scientific education, research and development, or non-clinical purpose.
  • $210 (annual licence for multiple consignments)

OR

  • $110 (licence per consignment only)
Wholesaler's licence $1,400
Both importer's licence (full scope) and wholesaler's licence $2,500

Note:

  • Turnaround time is 10 working days from the date of application or 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 of a licence

Licence renewal for Fee
Importer's licence (full scope) $520
Importer's licence for the following activities only (limited scope):
  • For export only.
  • For scientific education, research and development, or non-clinical purpose.
$210 (annual licence for multiple consignments)
Wholesaler's licence $520
Both importer's licence (full scope) and the wholesaler's licence $940

Note:

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

Amend a licence

Amendment type Fee
Amend an importer's licence (full scope) or wholesaler's licence with technical assessment  $1,100
Amend an importer's licence or wholesaler's licence without technical assessment $120

Note:

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

Manufacturer's licence

All manufacturers are required to hold valid manufacturer’s licence to manufacture a CTGTP which is not minimally manipulated.

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.

New licence application

Licence type Fee
Manufacturer's licence $22,000
Manufacturer's licence (secondary packaging only) $10,600

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").

Renew a licence

Licence type Fee
Manufacturer's licence $13,400
Manufacturer's licence (secondary packaging only) $3,600

Note:

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

Amend a licence 

Amendment type Fee
Amend a manufacturer's licence with technical assessment  $5,100
Amend a manufacturer's licence (secondary packaging only) with technical assessment $2,700
Amend a manufacturer's licence without technical assessment $180
Amend a manufacturer's licence (secondary packaging only) without technical assessment $180

Note:

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

Certificate of a Pharmaceutical Product

Application type Fee
Certificate of a Pharmaceutical Product for CTGTP $110

Note:

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

 

Good Manufacturing Practice and Good Distribution Practice certificates

Good Manufacturing Practice (GMP) certificates and Good Distribution Practice (GDP) certificates are valid for up to 3 years.

Certificates are non-renewable. Upon expiry, you will need to submit a new application if you are still interested in re-certification.

Application type Fee
GMP certificate
$22,000
GMP certificate without technical assessment
$210 per copy
GDP certificate $3,700
GDP certificate without technical assessment $210 per copy

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").

GMP Conformity Assessment of overseas manufacturers of CTGTP

Fees

Assessment types Fee (per manufacturing site)
Verification of compliance with GMP Standard (for overseas CTGTP Manufacturer) $620
GMP On-Site Inspection of an Overseas CTGTP Manufacturer  $31,500

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