It is a submission format for dossiers used in most ASEAN countries (Association of South-East Asian Nations).
The main aim of ACTD is to regulate the pharmaceutical regulations of the ASEAN member countries to complement and facilitate the objective of AFTA (ASEAN Free Trade Area), particularly, the elimination of technical barriers to trade posed by regulations, without compromising the quality, efficacy and safety of drugs.
The development of ACTD can also help developing nations to register their product in developed countries like the US and Europe hassle-free.
The ACTD format data requirement is nearly similar to those of CTD (Common technical document) which is accepted in some developed countries. Which is developed by the ICH working group with representatives from regulatory bodies in Europe, Japan and the United States.
The CTD is a set of specifications for the submission of regulatory data in the application for the right to market pharmaceuticals.
The ACTD format is used to facilitate the creation, review, life cycle management and archiving of the electronic submission, and it can be used as a step towards meeting the pharmaceutical regulations of developed countries.
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