Registration overview of therapeutic products

  1. Application Dossier

Application Dossier

Understand what is an application dossier, and the required formats to submit when you register your therapeutic product.

What is an application dossier

Application dossiers are technical documents accompanying a new drug application (NDA) or generic drug application (GDA). They should be submitted within two working days of the PRISM application submission for the NDA or GDA.

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. 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.

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.

Use the checklists below to guide you on compiling a complete application dossier. Each application must be accompanied by a completed checklist, which is to be attached in PRISM.

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 or in a CD/DVD.