Asia-Pacific Roundup: TGA defines its international engagement strategy
Australia’s Therapeutic Goods Administration (TGA) has released its international engagement strategy for 2021 to 2025. The document details TGA’s plans to work together to create a more globally aligned regulatory framework to reduce the burden. Of the industry.
TGA defines four objectives in the document. Over the next few years, the agency aims to “build a globally aligned regulatory framework that promotes sovereign decision-making”. TGA views such a framework as a way to reduce the regulatory burden on the industry while ensuring that products are safe, effective and of high quality.
Many of the specific activities that TGA plans to undertake to achieve this goal are a continuation of its existing work, such as participating in international forums to develop “timely and appropriate guidance” for medical devices. However, TGA said that the “unprecedented cooperation, collaboration, information sharing and understanding among international regulators” that have occurred in response to COVID-19 has created an opportunity to forge a framework that “s’ extends over the life cycle of therapeutic products ”.
The second objective of TGA is “to increase collaboration and information sharing with comparable regulators abroad in order to reduce the regulatory burden”. Again, work towards this goal is already underway, for example through TGA’s participation in the Access Consortium and the Orbis Project. TGA plans to continue these activities. Other specific activities include the use of “digital technologies” to perform manufacturing inspections and the sharing of the resulting information with other regulatory bodies.
The third objective is “to use international networks to monitor product safety and quality and maintain supply chains”. By working towards this goal, TGA wants to “build more real-world evidence to inform regulatory decisions” and “implement internationally aligned post-market regulatory controls”.
Finally, TGA wishes to “strengthen regional regulatory capacities for safer and more effective treatments”. In practice, this will mean seeking to strengthen the regulatory capacity of countries in the Southeast Asia and Pacific region. At first, the focus will be on responding to COVID-19.
The release of the strategy follows a period in which TGA has sought overseas to provide information on 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 guidance from the International Medical Device Regulatory Forum or the United States Food and Drug Administration, where applicable.
J&J Withdraw India’s COVID-19 Vaccine Application, As Japan, New Zealand Approve AstraZeneca Jab
Johnson & Johnson has withdrawn its request to introduce its COVID-19 vaccine to the Indian market. However, J&J subsequently stated Reuters he is still in discussions with the government and “is exploring how best to speed up our ability to deliver our COVID-19 vaccine to India”.
The Central Drugs Standard Control Organization (CDSCO) Subject Matter Expert Committee (SEC) revealed the withdrawal of J&J’s application in a summary of updates from its meeting late last week. It is not known why J&J withdrew the request. Updates from previous SEC meetings lack recommendations on the submission and data the committee would need to support fast-track approval.
At the start of the year, the SEC spoke out against the approval of the Pfizer-BioNTech vaccine, in part due to a lack of local data, but the CDSCO revised its position on vaccines approved abroad early June. In the face of a growing COVID-19 crisis, CDSCO has decided to exempt vaccines approved for emergency use in the United States, European Union, United Kingdom or Japan from the need to perform post-approval transition clinical trials.
The single-dose schedule, the ability to be stored at refrigerator temperature, and the non-profit price of J & J’s vaccine make the prophylactic vaccine potentially well suited for use in rural settings and in low- and middle-income countries. However, India’s wait for the vaccine looks set to continue.
News of the J&J app’s withdrawal in India emerged days after details of AstraZeneca’s progress in Japan and New Zealand. A Japanese health ministry panel approved AstraZeneca’s vaccine for use in patients over 40 at the end of last week, according to local media. The vaccine was cleared for emergency use in May, but the Department of Health has delayed approval for use in the vaccination campaign in Japan due to concerns over the very rare reports of blood clots.
New Zealand has also granted provisional consent for the distribution of the AstraZeneca vaccine. However, with the virus under control in New Zealand and the government planning to vaccinate everyone with the Pfizer-BioNTech vaccine by the end of the year, the doses are expected to be used overseas. New Zealand placed an order for 7.6 million doses of AstraZeneca last year, part of which was shipped to Fiji this week.
SEC Recommendations, Reuters, Medsafe update, The Japan Times
China breaks record for annual approvals of innovative drugs with months to spare
China approved 21 innovative drugs in the first half of the year, setting a new record with months to spare. The sharp increase in approvals has been supported by the development of COVID-19 vaccines.
Until 2019, China had never approved 10 or more innovative drugs in a year. The country reached a new high in 2020, when 20 innovative drugs were approved. In the first half of 2021, China approved 21 innovative drugs.
The 2021 approvals include the authorizations for three COVID-19 vaccines. Without these approvals, China would not have surpassed the 2020 total so quickly, but would still be on track to break the record.
The China Center for Drug Review (CDE) used the biannual update to share details of its efforts to implement the common electronic technical document and improve the approval process.
CDE Notice (China)
TGA shares guide to determining if software is regulated as a medical device
TGA has published a decision tree to help software developers determine if their products will be regulated as medical devices.
The decision tree asks a series of questions, some of which are accompanied by tips on how to get 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 classified for medical purposes under Australian law.
TGA’s guide also provides details on how software developers can determine if their product can be excluded from medical device regulation and if clinical decision support software is exempt.
Australian Court Fines Add A $ 11 Million To Company For Illegally Advertising Products
The Federal Court of Australia has ordered Evolution Supplements Australia to pay A $ 11 million ($ 8.1 million) for the illegal advertising of unapproved sports supplement products. The director of Evolution Supplements has to pay an additional A $ 1 million.
In February, the court found that the company and its sole director had illegally advertised to consumers drugs and prescription-only therapeutic products not on the Australian Therapeutic Products Registry. The court also ruled that the manager had failed to respond to requests from the TGA to stop running the promotions. The decision led to fines for the company and its director.
The court imposed the highest fines ever for violations of the Therapeutic Goods Act 1989 after reviewing the evidence of damage that could be caused by products promoted by Evolution Supplements. The TGA said the court had accepted evidence that selective androgen receptor modulators pose “a serious risk to human health and safety, if not used as part of TGA.”
© 2021 Society of Regulatory Affairs Professionals.