🇦🇺Australia

TGA Non-Compliance Penalties

2 verified sources

Definition

Clinical trial design and patient recruitment must comply with TGA regulations requiring notification and HREC ethics approval. Non-compliance or delays result in enforceable undertakings, fines, or trial halts, creating financial losses from rework and lost timelines.

Key Findings

  • Financial Impact: 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.
  • Frequency: Per non-compliant trial; high risk in recruitment ethics breaches.
  • Root Cause: Manual handling of complex ethics submissions and patient consent processes prone to errors.

Why This Matters

The Pitch: Biotechnology players in Australia 🇦🇺 waste AUD 100,000+ per delayed trial on redesign and penalties. Automation of trial design compliance eliminates this risk.

Affected Stakeholders

Clinical Operations Manager, Regulatory Affairs Specialist, Trial Sponsor

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

Delayed RDTI Tax Incentive Claims

AUD 100,000 - 1M forgone refund per delayed claim; 6-12 month ATO processing drag.

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)

Datenmanipulation und Verstoß gegen Aufbewahrungspflichten in Forschungsvorhaben

Quantified (logic-based): For a typical biotechnology clinical or translational research project with a total budget of AUD 5–20 million, suspension or major protocol non‑compliance can reasonably jeopardise 2–5% of funding and add 1–2% in remedial compliance costs (≈ AUD 100,000–700,000 per affected project) through lost milestone payments, remedial monitoring and legal/consulting costs.

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