TGA’s Latest Update on “eCTD AU Module 1 & Regional Information”
In a recent development, the Therapeutic Goods Administration (TGA), Australia has updated its guidance document titled “eCTD AU Module 1 & Regional Information,” making crucial changes to Module 1 v3.1 while adopting the International Council for Harmonization’s (ICH) electronic Common Technical Document (eCTD) v4.0 specification. This update significantly impacts sponsors and manufacturers, particularly those dealing with prescription medicines and their eCTD submissions.