🇦🇺Australia

TGA Non-Compliance Fines

1 verified sources

Definition

Regulatory submissions without proper fee payment or standards compliance incur statutory fines; logic-based on TGA enforcement for therapeutic goods.

Key Findings

  • Financial Impact: AUD 5,000+ minimum statutory fines for non-compliance (e.g., unapproved imports AUD 583+ per entry); 20-40 hours manual rework per rejected submission[1]
  • Frequency: Per violation or failed submission
  • Root Cause: Errors in manual TGA dossier preparation leading to rejections or penalties

Why This Matters

The Pitch: Biotech companies risk AUD 5,000+ fines for TGA submission failures. Automation ensures compliance and avoids penalty losses.

Affected Stakeholders

Regulatory Team, Legal Counsel

Deep Analysis (Premium)

Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

HREC Review Costs

AUD 6,000 typical HREC review fee + AUD 350 TGA notification[3]

TGA CTN/CTA Notification Costs

30-60 hours per trial (at AUD 250/hr specialist rate = AUD 7,500 - 15,000)

Biosafety Non-Compliance Fines

AUD 10,000 - 500,000 per breach (typical civil penalty range for regulatory contraventions)

HREC and SSA Approval Delays

20-40 hours per trial site (at AUD 200/hr = AUD 4,000 - 8,000 opportunity cost)

Embryo Research Licensing Overhead

15-30 hours per licence application (AUD 3,000 - 6,000 at AUD 200/hr)

TGA Non-Compliance Penalties

AUD 50,000 - 500,000 per violation (civil penalties up to 5,000 penalty units at AUD 313/unit); 20-40% trial budget overrun from delays.

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