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Asia-Pacific Roundup: TGA sets out international engagement strategy

Posted 03 August 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA sets out international engagement strategy

Australia’s Therapeutic Goods Administration (TGA) has published its international engagement strategy for 2021 to 2025. The document details TGA’s plans to collaborate on the creation of a more globally aligned regulatory framework to reduce the burden on industry.
 
TGA sets out four goals in the document. Over the next few years, the agency wants to “build a globally aligned regulatory framework that fosters sovereign decision making.” TGA sees such a framework as a way to reduce the regulatory burden on industry while ensuring products are safe, effective and high quality.
 
Many of the specific activities TGA plans to take to achieve that goal are continuations of its existing work, such as participating in international forums to develop “timely and appropriate guidance” for medical devices. However, TGA said the “unprecedented cooperation, collaboration, information sharing and understanding among international regulators” that happened in response to COVID-19 has created an opportunity to forge a framework that “spans the lifecycle of therapeutic products.”
 
TGA’s second goal is to “increase collaboration and information sharing with overseas comparable regulators to reduce regulatory burden.” Again, work toward that goal is already underway, for example through TGA’s involvement in the Access Consortium and Project Orbis. TGA plans to continue those activities. Other specific activities include the use of “digital technologies” to conduct manufacturing inspections and the sharing of the resulting information with other regulators.
 
The third goal is to “utilize international networks to monitor product safety and quality and maintain supply chains.” By working toward that goal, TGA wants to “build a greater body of real-world evidence for informing regulatory decisions” and “implement internationally aligned post market regulatory controls.”
 
Finally, TGA wants to “strengthen regional regulatory capabilities for safer and effective therapeutics.” In practice, that will mean seeking to strengthen the regulatory capacity of countries across the South-East Asia and Pacific region. An early focus will be on the COVID-19 response.
 
The publication of the strategy follows a period during which TGA has looked overseas to inform how products are regulated in Australia. TGA has aligned its medical device regulations with those of the European Union, while also basing its positions on International Medical Devices Regulatory Forum or US Food and Drug Administration guidance when appropriate.
 
TGA Strategy
 
J&J still in discussion with Indian authorities, as Japan, New Zealand approve AstraZeneca jab
 
Johnson & Johnson has withdrawn an application requesting accelerated approval for local clinical trials in India after the country dropped the requirement for "well-established" foreign COVID-19 vaccines. However, J&J subsequently told Reuters it is still talking to the government and “exploring how best to accelerate our ability to deliver our COVID-19 vaccine to India.”
 
The Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee (SEC) disclosed the withdrawal of the J&J application in a summary of the updates from its meeting late last week.
 
Early in the year, SEC recommended against the approval of the Pfizer-BioNTech vaccine, in part over a lack of local data, but CDSCO revised its stance on vaccines approved overseas in early June. Facing a mounting COVID-19 crisis, CDSCO decided to exempt vaccines that are approved for emergency use in the US, European Union, UK or Japan from the need to run bridging clinical trials.
 
The one-dose schedule, ability to be stored at refrigerator temperatures and not-for-profit pricing of J&J’s vaccine makes the prophylactic potentially well suited to use in rural settings and low- and middle-income countries. However, India’s wait for the vaccine looks set to continue.
 
News of the withdrawal of the clinical trial application in India emerged within days of details of progress for AstraZeneca in Japan and New Zealand. A Japanese health ministry panel approved AstraZeneca’s vaccine for use in patients over 40 late last week, according to local media reports. The vaccine was authorized for emergency use in May, but the health ministry held off on clearing it for use in Japan’s immunization campaign amid concerns about the very rare reports of blood clots.
 
New Zealand also granted provisional consent to the distribution of AstraZeneca’s vaccine. However, with the virus under control in New Zealand and the government planning to vaccinate everyone with the Pfizer-BioNTech jab by the end of the year, the doses look set to be used overseas. New Zealand put in an order for 7.6 million AstraZeneca doses last year, some of which it sent to Fiji this week.
 
SEC Recommendations, Reuters, Medsafe Update, The Japan Times
 
China breaks record for annual innovative drug approvals with months to spare
 
China approved 21 innovative drugs over the first half of the year, setting a new record with months to spare. The surge in approvals was supported by the development of COVID-19 vaccines.
 
Until 2019, China had never approved 10 or more innovative drugs in a year. The country hit a new high in 2020, when 20 innovative drugs won approval. Over the first half of 2021, China approved 21 innovative medicines.
 
The 2021 approvals include the authorizations of three COVID-19 vaccines. Without those approvals, China would not have surpassed the 2020 total so quickly but would still be on course to break the record.
 
China’s Center for Drug Evaluation (CDE) used the half-year update to share details of its effort to implement the electronic common technical document and otherwise improve the approval process.
 
CDE Notice (China)
 
TGA shares guide to determining if software is regulated as a medical device
 
TGA has released a decision tree to help software developers determine if their products will be regulated as medical devices.
 
The decision tree poses a series of questions, some of which are accompanied by guidance on how to reach an answer. The first question asks whether the purpose of the product is likely to be medical. In a supporting slide, TGA explains the intended uses that are classed as medical purposes under Australian legislation.
 
TGA’s guide also features details of how software developers can determine if their product may be excluded from medical device regulation and if clinical decision support software is exempt.
 
TGA Guide
 
Australian court fines supplement company AU$11M for unlawfully advertising products
 
The Federal Court of Australia has ordered Evolution Supplements Australia to pay AU$11 million ($8.1 million) over the unlawful advertising of unapproved sports supplement products. The director of Evolution Supplements has to pay a further AU$1 million.
 
In February, the court found the company and its sole director unlawfully advertised prescription-only substances and therapeutic goods not in the Australian Register of Therapeutic Goods to consumers. The court also ruled that the director failed to comply with TGA requests to stop running the promotions. The ruling has led to fines for both the company and its director.
 
The court imposed the largest-ever fines for contraventions of the Therapeutic Goods Act 1989 after considering evidence of the harm that can be caused by the products promoted by Evolution Supplements. TGA said the court accepted evidence that selective androgen receptor modulators pose “'a serious risk to human health and safety, if not used within the TGA framework.”
 
TGA Notice

 

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