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Full evaluation route registration guide

Follow this guide for documentary requirements, fees and turn-around-time to register your cell, tissue or gene therapy products (CTGTP) via the full evaluation route.

Eligibility

You must register your CTGTP via the full evaluation route if it has not been approved by any of our comparable overseas regulator at the time of submission.

Pre-submission notification

Notify us at least two months before you submit your full evaluation application via email to HSA_CTT_Enquiry@hsa.gov.sg with the following information:

  • Product name.
  • Active ingredients.
  • Summaries of quality, non-clinical and clinical data (e.g. Module 2.4 Non-clinical Overview, Module 2.5 Clinical Overview)
  • Planned submissions in other countries.
  • Planned date of submission to HSA.

Note: You may request for a pre-market consultation with us if it is necessary to discuss specific areas related to your application, including the need for an overseas Good Clinical Practice (GCP) inspection, where relevant. Your meeting request to us must be made at least four weeks before the proposed meeting date, with the meeting agenda clearly stated. Relevant documents such as presentation slides and briefing documents should be provided at least one week before the meeting.

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).
Documents Location in ICH CTD Location in ACTD Required for NDA full route
Administrative documents Module 1 Part I Yes
Common technical document overview and summaries Module 2 Incorporated in Parts II, III and IV Yes
Quality documents Module 3 Part II Yes
Non-clinical documents Module 4 Part III Yes
Clinical documents Module 5 Part IV Yes
 

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 turn-around-time for more information.

How to apply

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

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