Application submission
Understand the submission requirements and how to apply.
Last updated 2 April 2026
Application dossier
Application dossiers are the collections of technical documents supporting your application. You need to submit all documents in English. For documents which are not in English, a certified translation is acceptable.
Your application dossier must be organised in either an International Council for Harmonisation Common Technical Document (ICH CTD) or ASEAN CTD (ACTD) format. These formats use the modular framework described by the ICH Topic M4 (opens in new tab) and the ASEAN guidelines (opens in new tab) on the Common Technical Document for Registration of Pharmaceuticals for Human use: Organisation of the Dossier, respectively.
The table below summarises the organisation of each dossier format:
Organisation of Application dossier
Documents | Location in ICH CTD | Location in ACTD |
|---|---|---|
Administrative documents | Module 1 | Part 1 |
Common technical documents | Module 2 | Incorporated in Parts ll, lll and IV |
Quality documents | Module 3 | Part ll |
Non-clinical documents | Module 4 | Part lll |
Clinical documents | Module 5 | Part lV |
The dossier format used in registering the CTGTP will determine the submission format for future variation applications of your registered CTGTP.
Application checklist
Application checklists provide guides on the documentary requirements for the respective applications.
Each application must be accompanied by the chosen CTD application checklist, completed by the applicant:
NDA Checklist for Class 2 CTGTP (ICH CTD Format) (opens in new tab)
NDA Checklist for Class 2 CTGTP (ACTD Format) (opens in new tab)
Checklist for Registration of Class 2 CTGTP containing materials of animal origin (opens in new tab) (if applicable)
How to apply
Submit your applications through SHARE (opens in new tab).
Schedule a pre-market consultation with us, if necessary.
You may request for a pre-market consultation if it is necessary to discuss specific areas related to your application, including the need for an overseas Good Clinical Practice (GCP) inspection.
Your meeting request must be made at least five months before the proposed meeting date.