Registration overview of Class 2 CTGTP
- Application submission and screening
Application submission and screening
Understand how to submit a registration application and what happens during application screening.
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).
Files containing the below scripts will not be accepted due to cybersecurity reasons:
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 turn-around-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.
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.
- A GIRO account setup may take up to 4 weeks, which may surpass your payment due date. Please take this setup time into account when applying for GIRO account payment.
- If payment is not made through GIRO, an invoice will be sent via email. Both screening and evaluation fees must be paid upfront during submission. In this scenario, the evaluation fee will be refunded if the application is not accepted for evaluation.
How to apply
Submit your application through the relevant application form. Ensure you have the following before submitting your application:
Application screening involves us checking to ensure the application type is correct and that the dossier is complete. The screening timeline starts from the date of receipt of the application dossier.
Screening will not be done if:
- Screening fees are non-refundable after your application is submitted.
- If your application is identified to be more appropriately submitted under a different application type during screening, you will be informed of the change via an input request.
- The screening process only checks for completeness of the application dossier for evaluation. The acceptance of the dossier for evaluation does not denote the adequacy of the data for regulatory approval.
If the dossier submitted is incomplete, an input request stating the deficiencies will be issued to you. The stop-clock starts when the input request is sent and ends upon receipt of a complete and satisfactory response to the query. The total number of input requests sent during screening is capped at two. You will be given 20 working days to respond to each input request, starting from the date it was sent.
The application will only be accepted when all deficiencies have been adequately addressed and HSA is satisfied that the dossier is complete for evaluation. An acceptance notice will then be issued and the date of acceptance of the application will be taken as the start of the evaluation timeline.
Failure to address the deficiencies raised during screening will render the dossier incomplete for evaluation. An input request will be issued to you to withdraw the application. If the application is subsequently re-submitted, it will be processed as a new application.