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ASEAN Common Technical Dossier

ASEAN Publication > ASEAN Common Technical Dossier

ASEAN Common Technical Dossier

Author:ASEAN Secretariat


Abstract

This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. 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. Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements




More Details
Author ASEAN Secretariat
Barcode <000000002040> <000000002041> <000000002042> <000000011132>
Edition
Place Jakarta
Publisher ASEAN Secretariat
Year 2016
Classification

Economic - ASEAN Economic Minister Meeting (AEM)

207 – Standards and Conformance - elimination of technical barriers to trade, non-tariff barriers, non-tariff issues include specifications, regulations on safety and quality

207.6 – Pharmaceutical Product (PPWG), Medicinal product

Call Number 207.6 ASE a
ISBN 9786026392275
Language

English

Content Type Text Book
Media Type Print and Digital
Number of copies 3

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