Asia-Pacific Roundup: Australia’s TGA seeks feedback on fee increases, warns of need to cut costs

Australia’s Therapeutic Goods Administration (TGA) is planning to increase its fees and charges by 4.7% for the 2024 to 2025 financial year. The agency, however, warned the higher rate will not cover all known increases in its costs, and it will need to “find efficiencies and savings.”

TGA calculates an “indexation factor” based on the consumer and wage price indexes (CPI/WPI) to determine how much to increase its fees each year. In the year up to September 2023, CPI was 5.4%, down from more than 7% the year before. With WPI hitting 4% over the same period, TGA calculated an indexation factor of 4.7%.

The proposed fee increase comes at a time when TGA is dealing with two cost pressures that it expects to drive an AU$ 14.3M ($9.4M) increase in spending. TGA forecasts that employee costs will account for around half of the predicted extra spending, mainly because non-senior executive staff are set to get a 4% pay increase in March. An increase in leave provision and staff pay increments will also add to TGA spending when they take effect in July.

TGA said increased corporate costs will account for the remaining AU$ 7.3M in additional spending. The extra outlay is “mainly due to the yearly increase apportioned for depreciation/amortization (AU$ 6.1M) on TGA’s business and IT software systems and the inflation-based increase to corporate charge back (AU$ 1.2M) payable to the Department.”

The agency expects the 4.7% indexation factor to generate an additional AU$ 10.6M, meaning the forecast increase in revenue falls almost AU$ 4M short of the anticipated jump in costs. The actual shortfall could be larger if sponsors consolidate their listings on the Australian Register of Therapeutic Goods (ARTG). Officials plan to look for ways to reduce discretionary costs to close the gap between income and spending.

TGA also plans to raise annual charges to recover investments in its digital transformation and business systems enhancements. The agency used money in its reserves, spending AU$ 23.3M over two financial years, to pay for the work and will recover the costs from industry over the next five years.

The size of the fee increases, which were covered in last year’s consultation, are different for different types of products. A 1.78% increase related to the digital transformation project applies to all products, but the burden of recovering investment in the adverse event management system, device digitalization, and unique device identification only falls on sponsors of certain products. Class II and above medical device sponsors face the biggest fee increase of 4.98%. The total fee jump for those devices is 9.13%.

TGA is proposing further targeted changes to medical device fees. The agency plans to reduce the fee for Class 3 and 4 in vitro diagnostic application audit assessments from AU$ 22,387 to AU$ 14,198, subject to indexation, if no laboratory testing is required. The proposal will partly reverse the increase TGA imposed last year to address “significant under recovery mainly during the COVID time.”
TGA plans to keep the fee for assessments that require laboratory testing at AU$ 22,387. The agency discussed the proposals with trade groups late last year.

TGA said the groups “were generally supportive of the annual indexation increase” but maintained previously raised concerns about the extra charges for recovering the cost of investment in digital and business systems. The industry acknowledged the decision was taken by the government but noted the “cumulative effect, especially on smaller sponsors, and the impacts of parallel cost increases by other parts of the government.”

TGA is accepting feedback until 23 February.

TGA Consultation

TGA starts consultation on proposed adoption of 13 international scientific guidelines

TGA is seeking feedback on plans to adopt 13 international scientific guidelines. Adopting the documents is intended to provide guidance that helps sponsors meet their legislative obligations in Australia.

Eleven of the guidelines are from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH guidelines cover topics including the development of medicines in children, testing for carcinogenicity, residual solvents, controlling DNA reactive impurities, and general considerations for clinical studies.

The other two documents come from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The FDA guidance covers the clinical trial eligibility criteria for cancer patients with organ dysfunction or prior or concurrent malignancies. US officials published the document in 2020 to push back against the routine exclusion of people with organ dysfunction from clinical trials and thereby help sponsors enroll broader patient populations that better represent the real world.

TGA is also proposing adopting EMA’s guideline on evaluating anticancer medicinal products in men. EMA brought the latest version of the long-running guideline into effect in 2018 to reflect changes to the “collection and reporting of safety data in order to inform the benefit-risk evaluation, including a need for more differentiated and detailed safety data presentation.”

The Australian regulator wants to know if people support the adoption of the documents and why. TGA is accepting feedback until 4 March.

TGA Consultation

Malaysia’s NPRA rejects studies run by Indian CRO after EMA finds ‘irregularities’ in data

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has decided to reject all bioequivalence studies conducted at the BE Centre Synapse Labs in response to the findings of an EMA inspection.

Last month, EMA’s human medicines committee recommended the suspension of certain generic drug marketing authorizations tested by Synapse, an Indian contract research organization (CRO). EMA adopted that position after a good clinical practice inspection “showed irregularities in study data and inadequacies in study documentation and in the computer systems and procedures to appropriately manage study data.”

Since then, EMA has agreed to reexamine its opinion in response to requests from affected companies. Before news of the reexamination became public, NPRA decided to reject all bioequivalence studies run at the Synapse site with immediate effect.

The agency is rejecting all applications for the Evaluation on the Need for BE Study Inspection (BEDE) on bioequivalence studies conducted on or before 2023, canceling study inspection exemptions and delisting the center from its compliance program. Two studies of the antiretroviral drug darunavir and the cancer therapy erlotinib are exempt and can still be used to support product registration evaluation.

NRPA will consider accepting data from studies run in 2024 but will require study-specific inspections. The agency will not consider BEDE applications. NPRA published details of its actions on the day that EMA revealed it was reexamining its original decision.

NPRA Letter

Other News:

The Drug Regulatory Authority of Pakistan (DRAP) has created a “procedure for capacity assessment” for contract manufacturers. At a meeting last month, a DRAP board agreed to register contract production agreements in light of “capacity assessment of the contract accepter.” DRAP shared details of a process for inspecting contract acceptors to verify their capacity last week. DRAP Notice

Singapore’s Health Sciences Authority (HSA) has shared an alert about shoulder joint replacement devices that were packaged in defective bags. HSA Notice

Asia-Pacific Roundup: Australia’s TGA seeks feedback on fee increases, warns of need to cut costs

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