Clinical dossier definition registration#

This guideline merely demonstrates an appropriate write-up format for acquired data. Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements.

Clinical dossier definition registration#

This guideline describes a CTD format that will significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions. That will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals and biologics for human use.Īlthough the current ASEAN Common Technical Requirements (ACTR) has not included specific requirements for biosimilar products, the ACTD format is also applicable for biosimilar products. This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon commonįormat for the preparation of a well-structured Common Technical Dossier (CTD) application Neither the type nor extent of specific supporting data has been addressed in this guideline and both may depend upon national guidance and or accepted leading international references ( pharmacopoeias). The “Body of Data” in this guideline merely indicates where the information should be located.

To determine the applicability of this format for a particular type of product, applicant should consult with the appropriate National Regulatory Authorities. This format is appropriate for NCE (New Chemical Entity), Biotech (Biotechnological Products), MaV (Major Variations), MiV (Minor Variations) and G (Generics). This document is intended to provide guidance on the format of a registration application for drug products regarding ASEAN CTR.