PV Bulletin

TGA Approval 2026: Six Monthly Report Form for Unapproved Therapeutic Goods

TGA approved a new Six Monthly Report Form – Sponsor for 2026, replacing the 2021 version, for reporting unapproved therapeutic goods supply under SAS and CTA schemes.

Primary source: https://www.tga.gov.au/news/regulatory-decision-notices/therapeutic-goods-six-monthly-report-form-sponsor-approval-2026

PV Impact Brief

Urgency: LowConfidence: high

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.

Action needed

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.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
Country ComplianceICSR
Owner

Regulatory Intelligence Lead

Review cadence

Review before 2026-06-11.

Policy change details

Document type
Form
Policy status
effective
Publication date
2026-06-11
Effective date
2026-06-11
Policy change
The TGA has issued an approval for the 'Six Monthly Report Form - Sponsor' for 2026. This form is used by sponsors to report on the supply of unapproved therapeutic goods (medicines, biologicals, and medical devices) under the Special Access Scheme (SAS) and Clinical Trial Approval (CTA) scheme. The new form replaces the 2021 version and must be used for future reporting periods.

Key changes

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).

Affected workflows

Country ComplianceICSR

Responsible groups

Regulatory AffairsPharmacovigilance OperationsSafety Reporting

PV impact

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.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 11, 2026

Full briefing

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.

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.

View original source

Published from the Firecrawl policy change extraction pipeline.

#TGA#Therapeutic Goods Administration (TGA)#Reporting Requirement#Effective#Unapproved Therapeutic Goods#SAS#CTA#Form

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