🇦🇺Australia

TGA Submission Non-Compliance Fines

3 verified sources

Definition

Manual errors in dossier preparation or missed deadlines result in application rejection, requiring resubmission and payment of new fees. Standard pathway takes 255 working days with 75% fees due by day 15 of submission month.

Key Findings

  • Financial Impact: AUD 250,000+ evaluation fees per rejected submission; 255 working days delay blocking market entry
  • Frequency: Per new medicine registration application
  • Root Cause: Manual dossier compilation fails ARGPM compliance checks; poor tracking misses 20-day submission window

Why This Matters

The Pitch: Pharmaceutical manufacturers in Australia 🇦🇺 waste 100-200 working days and AUD 500k+ in evaluation fees per delayed submission. Automation of regulatory submission preparation and tracking eliminates this risk.

Affected Stakeholders

Regulatory Affairs Manager, Submission Coordinator, Compliance Officer

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

Regulatory Delay Opportunity Cost

~1 year market entry delay; AUD 1M+ monthly lost revenue for high-value therapeutics

TGA Evaluation Fee Overpayments

AUD 250k-500k evaluation fees per resubmission (75% upfront + 25% final)

TGA Non-Compliance Fines

AUD 20,000 - 500,000 per violation; 2-5% production downtime costs

Cost of Poor Quality from Trending Failures

AUD 100,000+ per failed batch; 1-3% of production costs

Idle Capacity from Review Delays

AUD 5,000-10,000/day idle bioreactor; 5-10% capacity loss

Kosten durch TGA-GMP-Abweichungen bei Änderungsdokumentation

Estimated: AUD 70,000–250,000 per major GMP inspection cycle in extra remediation labour, consulting and TGA‑driven compliance costs due to deficient change control documentation.

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