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THE ASEAN COMMON TECHNICAL DOSSIER (ACT) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN Reversion: Revision 1 Version 00 1.0Date 7th PWG Meeting 2003 27th PWG Meeting 2019Status AdoptedAuthor ACCSQPPWGEndorsed
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wwwfdagovphwp-contentuploadsactd asean common technical is a document that outlines the common technical requirements for pharmaceutical products in the ASEAN region.
Manufacturers and distributors of pharmaceutical products in the ASEAN region are required to file wwwfdagovphwp-contentuploadsactd asean common technical.
To fill out wwwfdagovphwp-contentuploadsactd asean common technical, manufacturers and distributors must provide detailed information about the quality, safety, and efficacy of their pharmaceutical products.
The purpose of wwwfdagovphwp-contentuploadsactd asean common technical is to harmonize regulatory requirements for pharmaceutical products in the ASEAN region and facilitate trade.
Information such as product specifications, manufacturing processes, stability data, and packaging information must be reported on wwwfdagovphwp-contentuploadsactd asean common technical.
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