TGA Fee Changes in 2026: Navigating TGA fee indexation, GMP costs, and regulatory budgeting
Budget Planning for Manufacturers
Manufacturers operating in Australia face a continually evolving fee environment, with the Therapeutic Goods Administration (TGA) updating its fees and charges annually through cost‑recovery frameworks. For FY2026, the primary indicators came from the TGA’s 2025–26 proposals and the fee schedules published in mid‑2025. These determine the cost structures applicable from 1 July 2025, directly shaping the financial planning landscape for manufacturers across medicines, medical devices and biologicals. This blog will review the 2026 regulatory fee environment, highlight key fee changes, and offer strategies for managing future cost pressures.
An Overview of TGA Fees: 2025–26 Cost‑Recovery Framework
The TGA operates under a full cost‑recovery model, meaning all regulatory activities – from product evaluations to GMP inspections – must be funded through fees and annual charges. The Cost Recovery Implementation Statement (CRIS) and annual public consultation outline how fees are set, adjusted and implemented. For FY2026, industry consultation occurred between 31 January and 28 February 2025, enabling stakeholders to influence the TGA’s proposed adjustments for 2025–26.
The TGA applies annual indexation using CPI/WPI‑based formulas under the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025. These amendments resulted in a 3.2% increase across fee categories for 2025/26, significantly lower than the previous year’s 4.7% increase.
Cost Recovery Implementation Statement 2025-2026
Key TGA Fee Updates Impacting Manufacturers in 2026
The fee categories most relevant to manufacturers—licensing fees, GMP certification, variation processing fees, and evaluation charges—are subject to indexation-driven increases. The TGA’s detailed fee tables for May–July 2025 show fee adjustments across prescription medicines, OTC medicines, complementary medicines, listed medicines, and medical devices. These provide the foundation for forecasts through 2026.
Medical device manufacturers, in particular, should note the continued application of risk-based fee structures. Class I devices attract lower application and annual charges and Class III/AIMD devices require substantially higher fees. For 2025, Class III device application fees exceeded $15,000–30,000, with annual charges around $1,566 per device. These values, updated September 2025, form the baseline for 2026 projections.
Note: The 2025 fees regulations Explanatory Statement notes the streamlining of medical device assessments (shorter timeframes, process changes) and that related fees were reviewed to reflect these improvements
The Explanatory Statement explicitly notes minor modifications to reduce indexation in 2025–26 because of the extra increases applied in 2023–24 and 2024–25 for digital/UDI cost recovery. Consequently charge increases for medicines, biologicals and medical devices ranges from 2.96-3.06%.
Licensing and GMP Certification Costs
Manufacturers holding TGA GMP licences or importing/producing regulated goods must budget for licence renewal and inspection costs. Annual charges apply to manufacturing licences under the Therapeutic Goods Act 1989, with updates issued via annual fee schedules each July. The TGA performs periodic GMP inspections to confirm compliance, and cost‑recovery means the expense of these inspections is passed directly to manufacturers.
The 2025–26 indexation uplift of 3.2% applies to manufacturing licence fees, GMP clearance applications and certification renewals. The indexed fees reflect the effort and resources required to undertake audits and evaluate evidence. This includes activities such as overseas GMP certificates, on‑site inspection reports, or conformity assessment documentation.
Routine Variations and Administrative TGA Fees in 2026
Routine variations, whether for listing updates, formula changes, manufacturing changes or device‑related amendment, also incur TGA processing fees. The 2025 fee schedules provide itemised costs for such variations across multiple product categories, including chemical entities, OTC products, complementary medicines and medical devices. As with all TGA fees, these variation charges are indexed annually and are therefore expected to increase in FY2026 in line with the 3.2% rate.
Practical implications for sponsors and manufacturers for 2025-2026
- Planning for FY2025–26: Assume ~3.2% uplift on most fees, and ~3% on annual charges (see category splits). Budget lines tied to device audits, clinical trial notifications, and consent/variation requests should reflect the 2025-25 fee structures.
- Medical devices: Those impacted in 2024–25 (e.g., Class II+ devices due to UDI/digital recovery) should expect a return to near‑indexation growth in 2025–26.
- Medicines & biologicals: Similar pattern – 2025–26 annual charge growth ~3.06%, fees ~3.2%. Track any use of the condition‑variation fee (in place since 1 Jan 2025).
- GMP/manufacturing licences: Annual charges indexed ~3.09% in 2025–26; inspection‑related fees follow the general 3.2% indexation.
Forecasting Administrative Costs Beyond 2026
Because the TGA regularly updates its cost‑recovery model, manufacturers should monitor annual CRIS publications, new indexation amendments, and any future changes tied to regulatory streamlining initiatives (such as faster device assessments). The TGA’s 2025 Explanatory Statement notes that streamlined processes are already influencing cost structures, and these will continue to shape the fee environment beyond 2026.
Manufacturers should incorporate an annual 3–4% indexation factor into planning unless the TGA releases materially different updates via consultation. This aligns budgets with historical adjustment patterns while allowing buffer capacity for category‑specific increases.
Effective budget planning for FY2026 depends on understanding the TGA’s fee mechanisms. Anticipate yearly indexation and leverage regulatory efficiencies where possible. By predictively using the TGA’s mid‑2025 fee schedules, manufacturers can prepare for the 2026 with confidence and financial accuracy.
- Use prior‑year fee schedules as a baseline: Because the TGA applies formula‑based annual indexation, the 2025–26 fee tables are likely to provide a close indicator for 2026–27 planning.
- Leverage Comparable Overseas Regulator pathways (FDA/CE): For devices, using comparable overseas approvals can reduce evidence requirements and, in some cases, streamline TGA evaluations—thereby reducing high evaluation fees.
- Consolidate variations: Instead of submitting multiple minor variations, consider grouping changes where permissible to reduce administrative processing fees. (Supported by TGA’s variation fee structures.)
- Participate in public consultations: Through the TGA’s annual fee consultation process, manufacturers can advocate for more proportionate fee structures or highlight unintended burden.
- Use Annual Charge Exemptions: Products not yet generating turnover may qualify for exemption from annual charges, reducing early‑stage costs.
- Build multi‑year regulatory budgets: Integrate GMP inspection cycles, device listing anniversaries, and product‑specific evaluation timings into three‑ to five‑year cost forecasts to anticipate high‑cost years.
PharmOut Services & Training
PharmOut supports manufacturers and sponsors in navigating the complexity of TGA licensing, GMP certification, and regulatory submissions. Our consultants can align regulatory strategy with TGA cost‑recovery frameworks and submission pathways. We also assist with licence applications and renewals, GMP readiness and inspection support, and preparation/management of regulatory submissions and variations.
You might explore elearning or public courses via onlinegmptraining.com, or contact us discuss your compliance and regulatory needs.
Frequently Asked Questions (FAQ)
The TGA funds its regulatory activity under a full cost‑recovery model. For 2025–26, most fees and annual charges have increased by approximately 3.0–3.2%. This reflects CPI/WPI‑based indexation set out in the Cost Recovery Implementation Statement and supporting legislation
Licensing fees, GMP inspection and certification costs, application and evaluation fees, and routine variation charges may likely to impact budgets. These costs apply across medicines, medical devices, and biologicals and are subject to annual indexation.
Because the government adjusts TGA fees using formula‑based indexation, the published schedules provide a reliable baseline for forecasting future costs. Manufacturers can reasonably plan for a further 3–4% uplift unless the TGA announces material regulatory.
Yes. Medical device fees have largely returned to standard indexation‑level growth, particularly for higher‑risk devices, following the previous year’s higher increases.
Manufacturers may reduce administrative burden by consolidating variations, using comparable overseas regulator pathways where applicable, applying for annual charge exemptions.
Regulatory budgets should be reviewed annually with the release of the TGA’s updated fee schedules and Cost Recovery Implementation Statement. Longer term forecasts should incorporate inspection cycles and major submission milestones.
