🇦🇺Australia

TGA CTN/CTA Notification Costs

2 verified sources

Definition

Sponsors must notify or obtain TGA approval via CTN/CTA schemes for clinical trials involving unapproved therapeutic goods, plus HREC review.

Key Findings

  • Financial Impact: 30-60 hours per trial (at AUD 250/hr specialist rate = AUD 7,500 - 15,000)
  • Frequency: Per clinical trial authorisation
  • Root Cause: Complex manual notifications and ethics integrations

Why This Matters

The Pitch: Australian biotech firms waste 30-60 hours annually per trial on TGA submissions. Automation of CTN/CTA filings recovers this capacity.

Affected Stakeholders

Regulatory Affairs Specialists, Trial Sponsors

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

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.

Delayed RDTI Tax Incentive Claims

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

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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