Asia-Pacific Roundup: TGA seeks feedback on plans to cut medtech fees, raise other charges

Australia’s Therapeutic Goods Administration (TGA) has proposed reducing specific medtech fees to streamline regulatory processes while implementing inflation-linked increases for others.

In 2021, TGA’s Medical Device and Product Quality Division asked external experts to review its fees and charges structure for medical device regulatory activities, identifying premarket fees that were too low to cover the costs of providing the services. At the same time, TGA began consultations about regulatory reforms, leading to new fees designed to align costs with the reformed processes.

Fees for conformity assessments stayed the same because TGA wanted to perform further analyses “to better understand the variability in costs, identify process improvements, and account for policy changes, such as those relating to acceptance of comparable overseas regulator certificates.” The agency has worked with sponsors to analyze the application audit and conformity assessment processes.

“We have committed to implementing shorter target assessment time frames, streamlined processes and improved transparency,” TGA said. “Implementation of the streamlined processes are underway, and the associated fees have been reviewed to identify adjustments required to reflect these new processes and the efficiencies realized.”

TGA is proposing to cut its fees for initial design examination and design examination of a change. The reductions affect fees for in vitro diagnostics (IVD) and other types of medical devices. TGA is planning to reduce the fee for an initial design examination of a non-IVD device by AU$5,926 ($3,688), bringing the rate down to AU$59,924. The fee for design examination of an IVD change is set to fall by AU$3,869.

The cuts are one of two medtech fee proposals put forward by TGA. The agency said the external review and its subsequent analyses have shown there “remains under-recovery in conformity assessment work, mainly due to the TGA’s fee reduction policy.” The findings have informed TGA’s plans to revise the policy, including applying fee reductions based on the number of devices included in an application.

“We propose to undertake more targeted consultation with impacted sponsors on the options to change the fee reduction policy,” the agency said. “To ensure transparency and engagement of sponsors, a consultation process will occur to discuss the proposal for how the TGA applies fee reductions in a consistent way for design examinations.”

TGA said it can update the fee reduction policy and guidance without changing regulations. The agency plans to hold a targeted consultation on its options early this year, “with a possible commencement date in 2025.”

The Australian regulator shared the planned changes to medtech fees alongside details of its intention to raise all fees and charges in line with inflation. TGA plans to increase fees by 3.2% and raise charges, such as annual medicines and biologicals payments, by around 3%.

A consultation on the proposals will end on 28 February. TGA plans to consider the feedback and submit the amendment for consideration by the federal government in May or June. The timeline is intended to give “sufficient notice” to affected businesses before the changes take effect on 1 July.

TGA Notice

DRAP publishes rules on advertising therapeutic goods in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) has published rules on advertising therapeutic goods, setting out how companies can apply to run ads and the restrictions imposed on promotional materials.

Companies need prior written permission from Pakistan’s Advertisement Board to run ads in the country. DRAP has created a form that companies must submit with a payment for each ad and product. Officials will consider the requests, seek input from other groups when evaluating over-the-counter drugs and medical devices, and issue approvals that impose conditions and are valid for two years.

All ads are subject to general conditions. DRAP has banned materials that contain direct or indirect comparisons to other therapeutic goods for the “purpose of attracting customers or to discredit other such product” and imposed other restrictions.

“Advertisement shall be presented with courtesy and good taste,” DRAP said. “Words and phrases implying urgency, uniqueness or such expressions which are absolute in character, such as ‘the most potent,’ ‘the most rapid,’ ‘the most efficacious’ or which make exaggerated claims or too general claims, such as ‘effective in all cases’ or ‘effective against all complaints’ or superlatives shall be avoided.”

DRAP Notice

CDSCO starts consultation into evaluating the performance of infectious disease test

India’s Central Drugs Standard Control Organization (CDSCO) is seeking feedback on a draft protocol for evaluating the performance of a human metapneumovirus (HMPV) test.

CDSCO created the HMPV real-time PCR protocol with the Indian Council of Medical Research to enable independent verification of manufacturers’ claims. The protocol covers topics such as preparing an RNA evaluation panel, choosing a reference assay, and blinding laboratory staff. CDSCO has provided a form for reporting details of the performance evaluation.

The consultation, open until 15 March, comes weeks after CDSCO released draft protocols for 14 tests against the chikungunya, dengue, and zika viruses. CDSCO will continue to accept feedback on the 14 draft protocols until 15 February (RELATED: Asia-Pacific Roundup, Regulatory Focus, 06 January 2025).

CDSCO Consultation

MDA updates guidance on placing HIV self-test kits on Malaysian market

Malaysia’s Medical Device Authority (MDA) has published the second edition of its guidance on bringing HIV self-tests to market.

MDA published the first edition one year ago. The second edition is shorter, coming in at half the length of its predecessor, because MDA has removed information such as two scenarios for registering HIV self-tests. The scenarios included workflow diagrams and explanatory notes for tests with and without overseas approvals. MDA cut the information from the second edition.

The resulting guidance is more narrowly focused on performance evaluation, conformity assessment procedures, labeling requirements, and other topics. MDA also updated its advice, providing additional information on topics such as what to do when a problem with a self-test is found during postmarket surveillance.

MDA Guidance

Philippine FDA threatens antibiotic cancellation and suspension over noncompliance

The Philippine Food and Drug Administration (FDA) has warned it could cancel batch notifications and suspend market distribution of antibiotics over a change in the regulatory process.

FDA’s warning follows the move to an online batch notification process for antibiotics. The agency has published guidance on the documents, steps, and schedules involved in the new process and provided an updated application form. All applications must conform to the new guidelines and use the new form starting 3 February.

The penalties for failing to follow the new process include canceling batch notification and suspending market distribution upon inspection. The FDA has moved to the new model as part of a push to streamline and improve regulatory processes.

FDA Notice

Other news

DRAP has published a recall alert about a substandard infectious disease drug manufactured by Sanofi Aventis Pakistan. Discussing the risks, DRAP said intravenous products that contain endotoxins can lead to potentially fatal organ failure. DRAP Notice

Hong Kong’s Department of Health has issued a warning about the illegal use of the pharmacy logo. The maximum penalty for illegally using the logo includes up to two years in prison. Press Release

Asia-Pacific Roundup: TGA seeks feedback on plans to cut medtech fees, raise other charges

Related topics

Recommended content

Welcome to the new RAPS Digital Experience