Asia-Pacific Roundup: Australia’s TGA consults on updated draft companion diagnostics guidance

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on its plans to revise the guidance on companion diagnostics, providing a guide to help companies determine if companion testing is needed and introducing a concept to recognize the diagnostic evaluations carried out as part of a medicine application. The agency published the current version of its guidance on regulatory requirements for in vitro diagnostic (IVD) companion tests in October 2022.

TGA would add a new section on the medicine or biological indications that need companion diagnostic (CDx) testing. The section would include a flowchart intended to help companies determine if they need a companion diagnostic for the safe and effective use of the therapy and, if so, whether Australian standard-of-care testing could provide the required data.

The draft also introduces the concept of a “companion testing plan” to recognize the companion diagnostic “component evaluations undertaken as part of the medicine application.”

“The purpose of the plan is to provide reassurance that there is access to at least one adequate IVD for companion testing and ensure the Australian patients can be treated for that indication safely and effectively. All applications for registration of a new medicine or biological indication that require CDx testing must include a companion testing plan,” the agency wrote in the draft.

While the plan is “not meant to be a comprehensive description of all possible companion tests that are available in Australia,” it needs to identify one IVD that TGA “considers adequate.” The IVD can be the subject of a concurrent submission for authorization in Australia, in which case the applicant can cross-reference to the relevant details of the diagnostic filing.

In the absence of a concurrent application, the plan “provides a mechanism for the TGA to evaluate the performance and validity of IVDs intended for companion testing.” The agency said its proposed approach “recognizes that there may be barriers to bringing a CDx to the Australian market for local supply, and Australian samples may have to be sent for testing internationally.”

TGA would prefer to avoid that scenario but the option is open to bridge the gap to the availability of local testing. The agency will only accept the sending of samples to “appropriately accredited” overseas testing facilities if the development of onshore testing with an authorized or notified test “is infeasible or incomplete.”

Other proposed changes include the addition of four case studies. The case studies describe situations such as the development of a test to detect PD-L1 in esophageal squamous cell carcinoma to identify patients for treatment with an anti-cancer monoclonal antibody. Because the IVD is essential for the safe and effective use of the drug and not a mainstream pathology test, the applicant must apply for inclusion in the Australian Register of Therapeutic Goods. TGA describes the evidence to include in the filing.

The draft guidance is open for comment until 17 June.

TGA Consultation

India publishes revised marketing code for medicines and medical device

India’s Department of Pharmaceuticals (DoP) has released the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, an updated guidance on promoting therapeutic goods.

The original guidance, released almost 10 years ago, established a voluntary marketing code. The updated code adds new information about brand reminders, continuing medical education and support for research. DoP has also stated that the code applies to medical devices.

In an analysis of the document, Deloitte said the updated code “addresses crucial topics” missing from the older document while largely retaining its content. “Further clarity may be necessary regarding its interplay with other regulations,” the analysts wrote.

The new section on brand reminders builds on existing restrictions on the provision of free samples. The new code permits the use of informational and educational items and free samples as brand reminders, if manufacturers comply with certain restrictions. Companies can provide items such as books, calendars and diaries if they are worth Rs. 1,000 ($12) or less and do not have “an independent commercial value for the healthcare professionals.”

The new section on continuing medical education notes that engaging healthcare professionals via conferences and other forms of education “should only be allowed through a well-defined, transparent, and verifiable set of guidelines based on which the pharmaceutical industry may undertake such expenditures.

“All pharmaceutical companies should share the details of such events conducted by them, including the expenditures incurred thereupon, on their website, and may be subject to independent, random, or risk-based audit for this purpose,” the code states. Overseas events are banned.

Another new section addresses support for research. Companies can engage with healthcare professionals to “provide rational support and encouragement to research and innovation through the industry-academia linkage” but only on projects approved by a competent authority. Healthcare professionals must provide “bona-fide research services, under a consultancy agreement.”

UCPMP, Deloitte Analysis

TGA seeks to clarify rules on CDSS software

TGA is seeking feedback on proposed clarifications of its position on the regulation of clinical decision support system (CDSS) software

The agency introduced clarifications to the Therapeutic Goods (Medical Devices) Regulations 2002 for software-based medical devices in 2021 to address a government request for improvements to the regulation of digital products. Since then, industry representatives and other people have raised questions and sought further clarification about CDSS and how they are regulated in Australia.

TGA has responded with a consultation document that outlines problems related to the use of the term “clinical decision support” by device suppliers, the incorrect application of the conditional exemption to IVD software and issues assessing the performance of CDSS software.

The agency has proposed four actions to address the problems. TGA is seeking feedback on whether to introduce a definition of CDSS, clarify the scope of a regulatory exemption, require software to provide the reasons behind its recommendations and change its guidance materials.

The consultation closes on 6 May.

TGA Notice

Indian government forms committee to reform drug, device pricing framework

India’s DoP has formed a committee to consider reforms to the framework for pricing drugs and medical devices.

The committee’s core members are three leaders from DoP and the National Pharmaceutical Pricing Authority (NPPA). Representatives of the Indian Pharmaceutical Alliance and Indian Drugs Manufacturers’ Association will serve as “special invitees from the industry.” The committee will invite other people to share their views.

Together, the committee members will consider reforms to NPPA, “how to balance price and availability of essential medicines,” and “how to design a price moderation framework” for medical devices and for emerging and precision therapies. The plan is to create a new Drugs and Medical Devices (Control) Order to achieve those objectives.

The committee will submit its report in three months.

Press Release

Other news

TGA has released draft guidance on high-risk implantable or cardiac invasive medical device clinical trials. TGA Consultation

Asia-Pacific Roundup: Australia’s TGA consults on updated draft companion diagnostics guidance

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