Asia-Pacific Roundup: TGA seeks feedback on temporary increase to Australia’s annual device charges
Australia's Therapeutic Goods Administration (TGA) is holding a consultation into a planned temporary increase to medical device annual charges.
TGA has reformed medical device pathways in recent years, including by increasing use of assessments from comparable overseas regulators and by cutting the proportion of applications subject to mandatory audits. TGA performs non-mandatory application audits to support its use of evidence from comparable overseas regulators.
However, the agency does not currently recover the costs associated with non-mandatory application audits. The funding gap led TGA to propose a temporary increase to medical device annual charges for the 2027 to 2028 financial year to recover the audit costs.
TGA is seeking feedback on plans to impose a 5% increase in the medical device annual charge on top of its across-the-board fee revision. Overall, the annual charges for medical devices will increase around 7.4%, depending on the risk class.
The agency proposed the action in the belief that increasing the annual charges is “the most practical mechanism for recovering these costs” until it finalizes the outcomes of a broader review of charging arrangements.
TGA is performing the review as part of its broader financial sustainability strategy. The agency will assess whether the current funding framework is sustainable, transparent, and fit for purpose. Through the review, TGA aims to identify opportunities to better align regulatory effort and revenue.
The funding review comes at a time when TGA is facing “unavoidable cost pressure growth each year.” In the coming financial year, TGA expects to face AU$7.1 million ($5 million) in cost pressures, AU$5.4 million of which relates to cost-recovered activities. The agency has proposed offsetting the pressures by raising AU$2.9 million and AU$2.5 million more from fees and annual charges, respectively.
TGA is accepting feedback on the proposals until 16 November.
India caps trade margins on Keytruda, Tagrisso, and 135 other oncology drugs
India’s National Pharmaceutical Pricing Authority (NPPA) has imposed a 30% cap on the trade margins of 137 oncology drugs, including Merck’s Keytruda and AstraZeneca’s Tagrisso.
An expert committee formed of oncologists, medical specialists, hospital experts, and government officers drew up the list of 137 drugs. Capping the margins of the products is in the public interest because it will “control excessive trade margins in the distribution and retail channel while safeguarding legitimate manufacturer revenues and preventing artificial market shortages,” the government said.
Market data indicates that the trade mark-up for non-scheduled anti-cancer drugs is “significantly high” in certain cases, officials said. The government has also observed differences between retail and hospital prices, including varying maximum retail price (MRP) discounts. The variations show that the MRP and the actual transaction price “may differ considerably,” the government added.
Pembrolizumab, the checkpoint inhibitor that Merck sells as Keytruda, has the highest global sales of the affected products. Other blockbuster medicines on the list include AstraZeneca’s Tagrisso, Bristol Myers Squibb’s Opdivo, and Johnson & Johnson’s Darzalex.
Affected manufacturers must tell NPPA their revised prices within seven days. The revised prices will take effect on 9 November. Manufacturers must display price lists on their websites and send the information to all retailers and hospitals. Officials will require drugmakers to maintain production and supply levels for the affected products to ensure timely and uninterrupted access for patients.
Retailers and hospitals must share new prices with patients and are responsible for ensuring the revised prices are charged from the date of implementation. State drug controllers will ensure compliance with the new prices.
The action builds on a pilot project that NPPA ran in 2019. Through the pilot project, NPPA capped the trade margins of 42 oncology drugs at 30%. After the action, the MRPs of 526 brands of non-scheduled anti-cancer medications fell by up to 90%.
Press Release, Gazette Notification
Japan’s PMDA shares advice on developing oncology companion diagnostics
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published guidance on developing companion diagnostics (CDx) in parallel with oncology drugs.
In an English-language translation of an “early consideration” document published this month, PMDA summarized how to assess whether a cancer drug needs an accompanying diagnostic and whether the product qualifies as a CDx. The document outlines practical development considerations, including the timing of consultations with PMDA.
Once a sponsor has identified a need for a CDx, they should share the development plan with PMDA as early as possible. The agency wants sponsors to share their plans no later than the consultation on the proposed design of the pivotal clinical trial.
The sponsor’s consultation materials should explain the rationale for using a CDx. PMDA also wants to see details of the diagnostic planned for the approval application, plus an assessment of its relationship to the test used during clinical development.
In principle, a CDx should be covered by insurance when the cancer drug is listed on the National Health Insurance drug price list. Sponsors should design their development schedules around the time required for CDx insurance coverage, the timing of the cancer drug’s listing, and the standard review period based on the CDx application, PMDA said.
Philippine FDA starts consultation into formulating risk management plans
The Philippine Food and Drug Administration (FDA) has released draft guidelines on formulating risk management plans (RMPs) for consultation.
Manufacturers and other stakeholders must submit an RMP as part of their applications for licenses to operate. The RMP must outline systematic approaches for identifying, assessing, and controlling risks throughout the supply chain. RMPs apply to activities including storage and distribution, complaint handling, adverse events, and product recalls.
FDA drafted the guidelines to define the scope and minimum requirements of RMPs, including those created by drugmakers. Other objectives include standardizing the process for preparing, documenting, and maintaining an RMP. FDA sees the guidelines as a way to ensure that risk management activities are appropriately implemented and documented.
The RMP should contain information about the company and a brief description of its approach to risk management. FDA wants manufacturers to share analyses of the risks they face, as well as the policies and procedures they have implemented to minimize, reduce, or prevent the threats.
FDA is accepting feedback on the draft until 23 November.
Malaysia’s MDA gathers views on conformity assessment and device registration
Malaysia’s Medical Device Authority (MDA) is seeking feedback on draft updates to guidance on conformity assessments and medtech registration submissions.
MDA’s proposed changes to the device registration document cover ISO 13485 certifications. The legal manufacturer should provide updated copies of the certificates or other acceptable quality management system paperwork. MDA also proposed adding notes on preclinical and clinical studies to the device registration guidelines, as well as to the conformity assessment document.
The agency published the first versions of the documents in March 2025. MDA updated the guidelines in September 2025. Throughout the revisions, the documents have remained focused on certification assessments for medical device registration and conformity assessments in the verification process.
MDA is accepting feedback until 4 November.
Other News:
Margarita Gutierrez has begun as director general of the Philippine FDA. Gutierrez is implementing “FDA RESET,” an initiative intended to deliver efficient, fair, transparent, and trustworthy regulatory services. FDA plans to set targets for its performance in 2027. FDA Notice
