ASEAN Common Technical Dossier  | Subtitle :
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.
Registration No : B2243
Author :
ASEAN Secretariat
Edition :
Impresum : Jakarta: ASEAN Secretariat, 2016
Description :
Language : English
ISBN 978-602-6392-27-5
Classification:
1. 200 - ECONOMIC COMMUNITY / 210.5 - TRADE AND FACILITATION - Standards and Conformance
Keyword :
1 ACTD
Availability :
Hard copies 3 of 3
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