Organization of the ASEAN Common Technical Dossier (ACTD) for the Registration of Pharmaceutical Products for Human Use

Pursuant to Administrative Order No. 2013-0021 known as the "Adoption of the Association of Southeast Asian Nations (ASEAN) Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR) for the Registration of Pharmaceutical Products for Human Use," the Center for Drug Regulation and Research (CDRR), in enhancing public health and welfare by providing faster access to and increasing availability of quality, safe and efficacious pharmaceutical products, hereby stipulates the format for the preparations of well-structured ACTD applications.

This Circular intends to provide assistance to stakeholders in the submission of applications with an organized structure following the ACTD format, for the documentation of data on the administrative, quality, non-clinical an clinical aspects of pharmaceutical products for human use that will be submitted to the CDRR for registration.

This Circular shall apply to all manufacturers, traders and distributors (e.g. exporters, importers and wholesalers) of pharmaceutical products.  However, this shall not cover manufacturers, traders, and distributors of single and multiple-component vitamin and mineral products, traditional medicines, over-the-counter preparations, household remedies, medical gases, and veterinary products.

 

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