eCTD AU Module 1 v3.2 Summary of Changes

News Healthcare & Pharma Guidance

Date: 9th Sep, 2024 Source: Therapeutic Goods Administration (TGA) Country: Australia Original Source

Brief

On "09/09/2024", the "Therapeutic Goods Administration (TGA)" issued an update regarding eCTD AU Module 1 v3.2. The update includes changes to regulatory activity leads, sequence types, and module 1 headers, as well as amendments to the Sequence Matrix and Document Matrix. The TGA has also expanded allowable file types to include .txt and .doc formats and introduced new requirements for work-sharing and partial withdrawals.

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Therapeutic Goods Administration (TGA)

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eCTD AU Module 1 v3.2 Summary of Changes

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eCTD AU Module 1 v3.2 Summary of Changes

Brief

Therapeutic Goods Administration (TGA)

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