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.

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 Application checklist for NDA and GDA)
• ACTD checklist (Appendix 3A Application 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:
1. Prepare your documents:  

• Key Points to Note when Preparing Documents for Submission via EasiShare
  
• EasiShare FAQ

2. 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

• Submission of Drug Master File
• Submission of Plasma Master File

How to Apply