Tag: Australia

ARIM, ARIM Publisher, Australia, eCTD, RIM+

Australia Proposing Mandatory eCTD starting 2019

In late October 2018, Australia’s Therapeutic Goods Administration (TGA) opened consultation regarding their proposed schedule to make eCTD mandatory for prescription drug dossier submissions. The full proposal document can be found at the link above.

ACUTA, ARIM, Australia, eCTD, Validator

ACUTA Validator now listed by the Australian agency

In November of 2017, we reported the details of Australia’s updated guidance for version 3.1 of their regional eCTD specifications. ARIM Suite Version 3.2, which was released shortly after that, provided full support for publishing and validating Australian submissions. While ACUTA Validator has been capable of accurately validating submissions to Australia’s Therapeutic Goods Administration (TGA) …

ACUTA, ARIM, Australia, Canada, eCTD, South Africa, Validator

ARIM 2.3.3 hotfix 11 and ARIM Validator 3.2 Released: Canada, Australia, South Africa updates

ACUTA has released new versions of ARIM 2.3.3 Hotfix 11 and ARIM Validator 3.2 (desktop). The primary features included in this release are: Support for South Africa (ZA) Validation specifications v2.1 Support for Australia (AU) v3.1 Validation and eCTD specifications. Support for Canada (CA) Validation specifications v4.2 Other cool enhancements: The license key can now …

ACUTA, ARCS, ARIM, Australia, eCTD, NeES

E-Submissions Looking Up Down Under

Australia’s Therapeutic Goods Administration (TGA) released updated guidance for both eCTD (electronic Common Technical Document) and NeES (Non-eCTD Electronic Submissions). Version 3.1 of the Australian regional eCTD specifications, and version 2.0 of the NeES specifications will be accepted starting January 1, 2018, and will be mandatory July 1, 2018. Because the eCTD and NeES are …