Asia-Pacific Roundup: TGA seeks feedback on proposed changes to drug shortage reporting

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on several proposals to improve reporting of medicines shortages and discontinuations. The current proposals reflect feedback received on related consultations in February and March.

The agency proposes to require sponsors of all reportable drugs to provide 12 months’ notice of a decision to permanently discontinue a medicine, up from 6 months, based on earlier feedback. Further, TGA is considering adding more medicines, such as oral opioids, to the list of products on the critical impact list. TGA sees its proposal to simplify reporting and free sponsors from the need to assess if discontinuation would be of critical impact.

Another proposal would increase the number of medicines covered by the reporting requirements. TGA has seen problems created by shortages of non-reportable products including non-prescription medicines, sterile intravenous fluids, contrast agents for medical imaging and radiopharmaceuticals

The regulator proposes to add 23 registered, non-prescription medicines critical to the health of patients in Australia to the Reportable Medicines Determination. The proposal includes a provision requiring sponsors of any approved drug to provide the TGA with detailed supply information on request.

TGA believes the proposal helps balance the regulatory burden on sponsors with the need to improve the monitoring of medicine shortages. The agency said the alternatives are to do nothing or to add all current registered non-prescription drugs to the Reportable Medicines Determination.

The regulator’s preferred plan would affect around 100 products in the Australian Register of Therapeutic Goods and 23 sponsors. Most of the sponsors already supply other reportable medicines, so TGA does not expect the proposal to significantly increase regulatory burdens.

TGA is not proposing to require the reporting of shortages of radiopharmaceuticals or most contrast agents. The agency said it would be “challenging for radiopharmaceutical sponsors to comply with the mandatory reporting timeframes for shortages when manufacturing or logistical issues arise.” TGA found a high regulatory burden and no meaningful benefit for contrast agent reporting because of the large number of products.

The agency is accepting feedback until 13 January.

TGA Consultation

India launches medtech industry scheme, targets regulatory compliance benefits

The Indian government has launched a scheme to strengthen the medical device industry. Officials aim to realize benefits, including “improvement in regulatory compliance specified for medical devices.”

Through the scheme, the government aims to address challenges, including a lack of infrastructure. The scheme features five components, including investment in common facilities such as R&D labs for medical device clusters and support for companies running clinical studies. Officials identified the common facilities and study support as ways to improve regulatory compliance.

Each component of the scheme accounts for around one-fifth of the total budget. Officials will provide grants for common facilities and testing centers and financial support for animal studies and clinical trials. Another component, which accounts for another fifth of the funding, will build capacity by offering training to people, including regulators.

The Department of Pharmaceuticals outlined how the scheme will work in operational guidelines. The document covers the eligibility criteria for the support, how officials will decide which projects to back and the schedule for the release of the grant funding.

Press Release, Operational Guidelines

Malaysia’s MDA starts consultation on obsolete and discontinued medical devices

Malaysia’s Medical Device Authority (MDA) is seeking feedback on draft guidance on the control of obsolete and discontinued medical devices. The MDA will accept feedback until 26 November.

The document is designed to help companies and healthcare professionals comply with the Medical Device Act. MDA said devices that are “orphaned, obsolete or discontinued” may still be used in healthcare facilities and other settings. The ongoing use of the devices requires “careful management to ensure patient safety and compliance with regulatory requirements,” the agency said.

Under Malaysian law, a medical device may be exempt from registration requirements if the manufacturer has declared it obsolete or discontinued and the regulatory authority has confirmed the product’s status.

The guidance describes the criteria for assessing whether a device is obsolete or discontinued. Both types of devices were previously available, are still in use, and are in a well-maintained condition, but they are no longer registered. One key difference between the two types of products is that obsolete devices no longer receive maintenance support, and no spare parts are made.

The rest of the guidance describes the process for applying to declare a device obsolete or discontinued and includes a submission form. MDA is aiming to evaluate applications and confirm the status of devices within 14 working days.

Draft Guidance

TGA withdraws drug advertising fine, plans to clarify rules in upcoming guidance

TGA has withdrawn the infringement notices it issued to InstantScripts one year ago. TGA fined InstantScripts AU$ 742,500 ($479,274) for alleged unlawful advertising of therapeutic goods but the online pharmacy sought a judicial review of the actions.

Nine months after InstantScripts applied for the review, TGA settled the proceedings and withdrawn the 45 infringement notices that caused the fine. InstantScripts has agreed not to make material changes to the functionality of the online prescription service of its website until the earlier of 30 June 2025 or the publication of further guidance by TGA in relation to the advertising of prescription medicines.

TGA said the withdrawal “takes into account the need for the efficient resolution of the court proceedings and InstantScripts’ ongoing efforts and commitments to amend its website” to address the concerns and ensure compliance. The agency added it will “continue to take strong enforcement actions to address unlawful advertising of therapeutic goods, consistent with our regulatory framework.”

TGA Notice

Other news:

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published details of a pilot project for post-approval changes using reliance. The project is intended to reduce timelines and improve efficiency for variation applications by leveraging the work of reference agencies. NPRA plans to conclude the pilot project in June 2025. NPRA Notice

Asia-Pacific Roundup: TGA seeks feedback on proposed changes to drug shortage reporting

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