Asia Regulatory Roundup: TGA Shares Guidance on Mitigating Ventilator Shortages During COVID-19 Pandemic

RoundupsRoundups | 31 March 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Shares Guidance on Mitigating Ventilator Shortages During COVID-19 Pandemic
Australia’s Therapeutic Goods Administration (TGA) has shared details of how clinicians can mitigate shortages of ventilators triggered by surging numbers of COVID-19 cases. The agency proposes the modification of devices such as anaesthesia gas machines and production of ventilators based on the specifications drawn up in the United Kingdom as ways to counter anticipated shortages.
Like the rest of the world, Australia faces the prospect of its intensive care capacity, particularly the availability of ventilators, being overwhelmed by fast-rising numbers of COVID-19 cases. TGA pointed to that risk in new guidance, in which it warned there “may be a shortfall” in the devices.
With many countries trying to buy ventilators simultaneously, conventional sources of the devices may not be able to ship the equipment Australia needs to ensure capacity exceeds demand. As such, TGA has sketched out fallback options for sites that lack enough approved conventional full-featured ventilators to treat all patients with respiratory failure.
TGA’s plan echoes and draws on those established by its peers, including the United States Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA). Like FDA, TGA is allowing organizations to modify devices for use in the pandemic.
TGA thinks emergency ventilators and anaesthesia gas machines can be used in patients who need mechanical ventilation without creating undue risks, although it warns clinicians need to understand how the devices differ to minimize the risks to patients. TGA is “strongly” discouraging the use of anaesthesia devices in pediatric and neonatal patients.
By permitting the use of the devices in patients needing mechanical ventilation, and using equipment including continuous positive airway pressure machines in people with respiratory insufficiency, TGA may be able to close the gap between supply and demand. However, the agency recognizes the steps may not be enough to ensure all patients who need a ventilator can access one.
Given that risk, TGA linked manufacturers to MHRA’s recently published specifications for a rapidly manufactured ventilator system. MHRA created the specifications to help manufacturers, including those that do not normally make medtech devices, to produce ventilators. TGA said devices made to the specifications, “with adaptations to apply equivalent Australian standards,” may be a valuable resource for clinicians dealing with a surge in patients with severe respiratory problems.
The day after TGA issued its guidance, the Philippine Food and Drug Administration (FDA) added ventilators to a list of devices covered by a circular on the regulation of products donated to support the fight against COVID-19.
TGA Guidance, FDA Notice
TGA Tries to Clear up Confusion Over What Software is Regulated as a Medical Device
TGA has begun a consultation intended to clear up confusion about what software is considered to be a medical device for regulatory purposes. The agency is seeking input on what kinds of software should be exempt from requirements such as listing in the Australian Register of Therapeutic Goods (ARTG).
Last year, TGA held a consultation on the regulation of software. The feedback suggested, “There was confusion over what was considered a medical device,” according to TGA, leading the agency to put the clarification of the regulatory boundaries on its to-do list. TGA moved a step closer to clearing up the situation last week by starting a consultation on the topic.
The consultation asks what kinds of software-based products should be exempted from inclusion in the ARTG, and what kinds of software-based products should be excluded from regulation by TGA. In both cases, TGA wants respondents to justify the exclusions and exemptions, for example by pointing to existing regulatory oversight that negates the need for the application of the rules on therapeutic goods.
TGA highlighted software used by consumers to manage diseases as an example of a type of product that may be eligible for exemption on the grounds that there is no potential for significant harm. Software used by healthcare professionals for class-based analyses, not patient-specific diagnosis and management, may be eligible for exemption on similar grounds.
The consultation also identifies some classes of software that may already be subject to appropriate oversight. For example, accreditations held by laboratories may negate the need for TGA to regulate the information management software used at such sites.
TGA is accepting feedback until 13 May.
TGA Consultation
Australia, New Zealand and Pakistan Move to Stop Off-Label use of Drugs in COVID-19
Several countries in Asia Pacific have restricted distribution of chloroquine and hydroxychloroquine in response to demand for the products in the treatment of COVID-19.
With chloroquine and hydroxychloroquine emerging as potential treatments for COVID-19, interest in the drugs has soared. That creates a potential problem for patients who need the medicines to treat malaria and autoimmune diseases including lupus, who face the prospect of being unable to source their medications.
TGA moved to mitigate that risk last week by restricting the power to prescribe hydroxychloroquine to specialists in certain fields. The new rules permit specialists in intensive care medicine to prescribe the medicine, meaning physicians who treat the sickest COVID-19 patients could still administer the drug, but TGA is strongly discouraging the use of hydroxychloroquine in coronavirus patients.
Australia’s TGA imposed the restrictions within days of similar actions by its peers in New Zealand and Pakistan. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) revealed the Pharmaceutical Management Agency has limited funded access to hydroxychloroquine, while the Drug Regulatory Authority of Pakistan (DRAP) has put restrictions on sites that sell chloroquine. DRAP took the action after observing “hoarding” of the drug.
TGA Notice, Medsafe Statement, DRAP Alert
TGA Relaxes Batch Release Requirements to Facilitate Drug Supply During Pandemic
TGA has temporarily stopped requiring sponsors of biological medicines and biosimilars to send physical samples for batch release. The agency dropped the requirement to facilitate the release of medicines during the COVID-19 pandemic.
Sponsors first learned of the change via email. However, last week TGA felt it necessary to publish a reminder about the relaxed rules on its website.
In the notice, TGA said sponsors should still supply protocols for products on batch release. To cut turnaround times, batch release will be done using the protocols alone. Older products not on batch release, pre-market evaluations and post-marketing monitoring of biological medicines and biosimilars are not affected by the relaxed rules.
TGA will reassess its position on the provision of physical samples in June.
TGA Notice
Other News:
China’s National Medical Products Administration (NMPA) has approved a medical device based on real-world data. The product, a glaucoma drainage tube, was assessed in China in a real-world data pilot project that evaluated racial differences in the performance of the device. NMPA set the stage for the approval last year by establishing the real-world data initiative. NMPA Notice (Chinese)
TGA has found no evidence to support the intravenous administration of high doses of vitamin C to manage COVID-19. Clinical trials of the intervention are underway, but as it stands, there are no peer-reviewed studies in the medical literature. TGA issued its notice days before the Philippine FDA warned against the use of a vitamin B combination therapy. TGA Notice, FDA Statement
India’s Central Drugs Standard Control Organization (CDSCO) has published details of the hand sanitizers it approves. CDSCO List


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