Pharmaceutical Registration Dossier

Description

ACTD Format Dossiers

ACTD Format Dossier is also Described  as ASEAN CTD Dossier, ASEAN Common Technical Dossier (ACTD) provides a common format for the preparation of well-structured Common Technical Dossier applications for submission in ASEAN regulatory authorities for the registration of pharmaceuticals for human use. ACTD format significantly reduce the time and resources needed to compile applications for registration.  Regulatory reviews and communication with the applicant is facilitated by a standard document of common elements.

This guideline merely demonstrates an appropriate write-up format for acquired data. However,applicants can modify, if needed, to provide the best possible presentation of the technical information, in order to facilitate the understanding and evaluation of the results upon pharmaceutical registration.

Dossier writing and compilation as per ACTD Format.

Asian Common Technical Documents consists of following parts.

Part I Administrative Data and Product Information
Part II Quality Documents
Part III Non Clinical Documents
Part IV Clinical Documents.

ACTD Format is Asian harmonization for Common technical Documents used in

Asian Countries like Vietnam, Thailand, Singapore, and Malaysia, Philippines

& in Member States.