4. Application Dossier
Understand what is an application dossier, and the required formats to submit when you register your therapeutic product.
Last updated 20 May 2026
What is an application dossier
Application dossiers are technical documents accompanying a new drug application (NDA) or generic drug application (GDA). Applicants must organise the dossier (i.e. folders and subfolders) according to the CTD format and to include bookmarks in all documents to facilitate the retrieval of documents.
All documents must be in English and submitted in an electronic format (non-eCTD or eCTD). PDF files submitted must be in a format that is searchable, flattened (without layers) and without encryption. Files that are layered, password-protected, or have security restrictions will not be accepted.
Types of application dossier formats
Your application dossier submitted to us must be organised in either the International Council for Harmonisation Common Technical Document (ICH CTD) or the ASEAN CTD format, with both non-eCTD and eCTD options available for ICH CTD. These formats use the modular framework described by the ICH Topic M4 and the ASEAN guidelines on the Common Technical Document for Registration of Pharmaceuticals for Human use: Organisation of the Dossier, respectively.
The table below summaries the organisation of each dossier format.
List of dossier format summaries
Documents | Location in ICH CTD | Location in ACTD |
Administrative documents | Module 1 | Part I |
Common technical document overview and summaries | Module 2 | Incorporated in Parts II, III and IV |
Quality documents | Module 3 | Part II |
Non-clinical documents | Module 4 | Part III |
Clinical documents | Module 5 | Part IV |
Note: The CTD format cannot be changed once the application is submitted. Any subsequent variation applications for the product should follow the same format.
Application checklists
Each application must be accompanied by a checklist, completed by the applicant and attached in PRISM.
Use one of the following application checklists for your choice of CTD. Each checklist provides details on the specific documents that need to be submitted with your application. Submit the completed checklist together with your application dossier for application screening.
ICH CTD checklist (Appendix 2A Checklist for NDA and GDA)
ACTD checklist (Appendix 3A Checklist for NDA and GDA)
Note: Your choice of CTD 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 chosen here.
How to submit the dossier
Application dossiers must be submitted to HSA within 5 working days of the PRISM application submission.
Non-eCTD submissions (ICH and ACTD formats)
Submit via PRISM, CD/DVD or EasiShare
All administrative documents under Module 1 (ICH CTD) or Part I (ACTD) must be submitted in soft copy in PRISM. The other parts of the ICH CTD or ACTD may be submitted online via PRISM, CD/DVD or third-party cloud-based file exchange software (EasiShare).
To submit via EasiShare:
Prepare your documents:
Request for access (click here) to EasiShare for dossier submissions.
eCTD submissions (ICH format only)
Submit via SG-HSA eCTD portal
Applicants must prepare the dossier according to the current SG-HSA eCTD Specification and submit the eCTD package via the SG-HSA eCTD portal. In addition, applicant must upload a file named with the eCTD ID in PRISM document section 7.1 – CD Submission to indicate that the submission is via eCTD.
Other dossier types
How to Apply
Submit your application through PRISM. Ensure you have the following before you access the e-service:
If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).
Refer to our Guideline on PRISM Submission for more details on how to submit.
More details on submission requirements may be found in our Guidance on Therapeutic Products Registration