Registration of Class 2 CTGTP

  2. Application submission

Application submission

Understand the submission requirements and how to apply.

Submission requirements

Application dossier

You must submit the application dossier within 2 working days of the application and organise it in either an International Council for Harmonisation Common Technical Document (ICH CTD) or ASEAN CTD (ACTD) format. You need to submit all documents in English.

Your application dossier must be submitted to us in a CD/DVD labelled with the following information:

  • Product name.
  • Application type.
  • Contents of the CD/DVD (e.g. Module 1).

Application checklists

Each application must be accompanied by an application checklist, completed by the applicant and attached in the online application form.

Use one of the following application checklists based on your choice of CTD format. Each checklist provides details on the specific documents that need to be submitted with your application.

Note: Your choice of CTD  format submitted for NDA will determine the submission format for the rest of your product life cycle. This means that future applications for changes to your registered product (variation application) will have to be in the same CTD format.

Fees and turn-around-time

Refer to CTGTP fees and turnaround time for more information.

Two types of fees are payable for a new CTGTP registration application:

  • Screening fee, payable upon successful online application.
  • Evaluation fee, payable uppon dossier acceptance for evaluation.

GIRO payments

You are encouraged to make payment via GIRO. To activate GIRO payment, please fill up the Inter-bank GIRO Application Form227 KB and mail the original copy to:

Health Sciences Authority, 11 Outram Road, Singapore 169078.

Upon successful GIRO deduction, an e-mail will be sent to you informing of the completion of the retention procedure.

 

How to apply

Submit your application through the relevant application form. Ensure you have the following before submitting your application:

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