Application dossiers are technical documents accompanying your new CTGTP registration (NDA). They should be submitted within two working days of the application submission.
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.
|Location in ICH CTD
|Location in ACTD
|Common technical document overview and summaries
|Incorporated in Parts II, III and 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.