TGA approved a new Six Monthly Report Form – Sponsor for 2026, repealing the 2021 version, effective June 11, 2026.
Sponsors and MAHs in Australia must use the updated form for periodic reporting of unapproved therapeutic goods supply; failure to use the correct form may result in non-compliance with TGA reporting obligations.
Sponsors and MAHs must replace the 2021 form with the new 2026 approved form for all six-monthly reports on unapproved therapeutic goods supplied under SAS and CTA schemes.
Regulatory Intelligence Lead
Review before 2026-06-11.
Introduction of a new approved form for six-monthly reporting of unapproved therapeutic goods; Repeal of the 2021 version of the form (Approval of Six Monthly Report Form - Sponsor 2021).
Sponsors and Marketing Authorisation Holders (MAHs) in Australia must ensure that the updated form is used for their periodic reporting of unapproved therapeutic goods supply, ensuring compliance with TGA reporting formats and timelines. This affects teams responsible for regulatory reporting and country compliance.
Sponsors and MAHs must replace the 2021 form with the new 2026 approved form for all six-monthly reports on unapproved therapeutic goods supplied under SAS and CTA schemes.
The Therapeutic Goods Administration (TGA) issued an approval for the 'Six Monthly Report Form - Sponsor' for 2026, effective June 11, 2026. This form replaces the 2021 version and must be used by sponsors for periodic reporting of unapproved therapeutic goods supplied under the Special Access Scheme (SAS) and Clinical Trial Approval (CTA) scheme. MAHs in Australia must adopt the updated form to ensure compliance with TGA reporting formats and timelines.
What changed: TGA approved a new Six Monthly Report Form – Sponsor for 2026, repealing the 2021 version, effective June 11, 2026.
Why it matters: Sponsors and MAHs in Australia must use the updated form for periodic reporting of unapproved therapeutic goods supply; failure to use the correct form may result in non-compliance with TGA reporting obligations.
Practical implication: Sponsors and MAHs must replace the 2021 form with the new 2026 approved form for all six-monthly reports on unapproved therapeutic goods supplied under SAS and CTA schemes.
Published from the Firecrawl policy change extraction pipeline.
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