Regulatory Focus™ > News Articles > 2021 > 1 > Asia-Pacific Roundup: TGA studying risk classification of circulatory system devices

Asia-Pacific Roundup: TGA studying risk classification of circulatory system devices

Posted 12 January 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA studying risk classification of circulatory system devices

The Therapeutic Goods Administration (TGA) is holding a consultation on the definition of “central circulatory system” (CCS) in the Australian medical device regulations. TGA identified concerns about the misalignment of the current definition with the European Union in an earlier consultation.
 
That earlier consultation, which took place in 2019, sought feedback on proposed changes to the classification of medical devices that come into direct contact with the CCS. At that time, TGA did not plan to amend the CCS definition. Respondents to the consultation took a different position. Two of the three respondents called for TGA to align the definition with the EU. The third respondent raised the issue of the misalignment.
 
The misalignment stems from the exclusion of common iliac arteries from the EU definition. Due to the exclusion, some devices have a lower risk classification in the EU than in Australia. As TGA puts the devices as Class III, not the Class IIa used in the EU, manufacturers need to obtain additional conformity assessment documentation and possess more clinical evidence to enter the Australian market. The misalignment goes against pressures on TGA to align with the EU framework.
 
TGA has put two questions to the industry to inform its thinking about the definition. Firstly, TGA wants to hear views on the risk classification of devices that come into contact with the common iliac artery and other CCS blood vessels. Secondly, the agency is asking for details of other issues related to the safety and performance of common iliac artery devices. Responses to the consultation will influence whether TGA deems it necessary to exclude common iliac arteries from its CCS definition.
 
The consultation is open for feedback until 10 February.
 
TGA Notice
 
Medical products industry voices support for TGA’s handling of COVID crisis
 
TGA has responded effectively to the COVID-19 crisis, according to two-thirds of medical industry respondents to a survey from the agency.
 
TGA sent the survey via email and accepted responses in July and August. More than 1,500 people working in the medical products field, plus smaller numbers of healthcare professionals and other stakeholders, responded to the survey. TGA engaged a market research provider to get the views of more consumers and pharmacists, who TGA struggles to reach via emailed surveys.
 
Sixty-seven percent of respondents from the medical products industry agreed or strongly agreed that TGA “has responded effectively to the COVID-19 pandemic”; 5% disagreed. The remaining industry respondents were either unsure or neutral about TGA’s handling of the pandemic. A similar pattern emerged in the responses from pharmacists. TGA saw a higher percentage of neutral or unsure responses among consumers.
 
Responses to other questions suggest the medical products industry is broadly supportive of TGA’s work. Between 5% and 15% of respondents disagreed with statements about the agency TGA’s performance such as the agency takes strong action and strikes the right balance between safety and access.
 
Support was weakest for statements about how TGA interacts with industry. Between 14% and 15% of respondents disagreed with statements that TGA provides input opportunities, listens to feedback and is collaborative. Even so, 52%-60% of respondents agreed with the statements and 20% strongly agreed.
 
TGA Report
 
Philippine FDA vows fast review of AstraZeneca vaccine
 
AstraZeneca has applied for emergency use authorization (EUA) of its COVID-19 vaccine from the Philippine Food and Drug Administration (FDA). FDA plans to decide on the vaccine within 21 days of receiving the request.
 
The AstraZeneca vaccine, which is approved for emergency use in countries including India and the United Kingdom, is under review as is Comirnaty (Pfizer/BioNTech). With FDA aiming to make decisions within 21 days of receiving an EUA request, the Philippines could be vaccinating people with two products by the end of January,
 
Russia’s Gamaleya National Center of Epidemiology and Microbiology submitted an EUA request for its Sputnik V vaccine last week. However, pre-assessment of the application by FDA identified a need for additional documents. The setback follows the registration of Sputnik V by multiple countries in recent weeks. Since Belarus became the first foreign country to register Sputnik V late last year, Argentina, Bolivia and Algeria have cleared the vaccine for use in their populations.
 
FDA Notice
 
Persistent problems drive PMDA to change advice on handling insulin vials
 
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) wants healthcare professionals to administer insulin in syringes designed for the task following reports of medical accidents stemming from the use of incorrect syringes.
 
Insulin syringes featuring markings to show how many units have been drawn from the vial; by contrast, general-purpose syringes show how many milliliters have been drawn. The different units can lead to adverse events.
 
In its updated materials, PMDA cites the case of a healthcare professional who administered 0.4 mL  of insulin instead of  4 unit. In fact, the syringe contained 40 units, resulting in hypoglycemia. PMDA also noted the risk of incorrect conversions leading to hyperglycemia.
 
PMDA changed the package inserts of insulin vial preparations last year, before going on to revise the safety information on insulin syringes. PMDA shared details of the changes in a safety publication last week.
 
PMDA Notice
 
Australian committee debates use of digital expiry dates for COVID-19 shots
 
TGA’s Advisory Committee on Vaccines (ACV) has debated the use of digital expiry dates for COVID-19 vaccines. ACV sees digital expiry dates as a way to adapt to the provision of updated shelf-life stability data after the registration of a vaccine.
 
The pace of COVID-19 vaccine development has raised the prospect that TGA may have limited data on the shelf life of a product at the time of approval. Using digital expiry dates would make it easier to update product labels in response to stability data generated after a vaccine is approved for use in Australia. ACV is yet to share full details of its discussion of the topic.
 
Australian officials expect TGA to approve Comirnaty (Pfizer/BioNTech) by the end of the month. If TGA hits that target, the Australian government will bring forward the start of its vaccination campaign to February. The change to the vaccination start date follows the emergence of new clusters of COVID-19 in a country that has had relatively few cases to date. 
 
TGA Notice
 
Other News:
 
India’s National Pharmaceutical Pricing Authority (NPPA) has published a list of the 324 overcharging cases it is litigating. The list features cases involving companies including Pfizer and Sanofi. NPPA shared the list so the targeted companies can see the status of their cases and provide feedback if needed. NPPA Notice

 

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