TGA expedites COVID-19 approvals, while keeping up business as usual for other devices
The TGA continues to provide timely responses and support for new applications and emergency use applications. Our firm continues to be in active communication with the agency, which at the moment, is conducting all regulatory activities remotely. TGA continues to work hand-in-hand with industry and are extremely responsive given the current COVID-19 challenging health dynamics.
As of 25 March 2020, we have no indication that standard review cycles will be interrupted with the TGA. Companies wondering if it is worthwhile to submit new medical technology applications should rest assured TGA is doing everything they can to continue to meet KPIs and response timelines.
TGA is taking special actions to ensure that Australia is provided with approved COVID-19 diagnostics and associated therapies.
The following is a summary of some of TGA’s emergency procedures for expedited access to pandemic related devices. Click here for a more detailed discussion of expedited access pathways. Also, sign up for our April webinar on TGA’s emergency powers and expedited pathways.
TGA also publishes current information on its website.
Emergency Use Diagnostics for COVID-19:
The TGA is currently undertaking an expedited assessment process based on the information and performance data currently available at the time of application for inclusion on the ARTG.
The TGA encourages potential suppliers to submit an application for inclusion of their COVID-19 tests on the ARTG. All applications in relation to COVID-19 tests are being expedited as a matter of priority. To ensure applications are assessed rapidly, the TGA encourages sponsors to contact them through [email protected] and immediately provide supporting technical files/data for assessment.
The TGA is committed to supporting suppliers in their understanding of the Australian requirements for the supply of accurate COVID-19 tests.
COVID-19 diagnostic exemption for accredited pathology laboratories (issued 23 March 2020):
Further, TGA has provided an exemption for COVID-19 tests to accredited pathology laboratories to be utilised in their laboratories. In practice this emergency exemption allows COVID-19 diagnostic tests to be immediately supplied to accredited pathology laboratories approved under the Health Insurance Act 1973, while the TGA continues to expedite the regulatory assessment process for these devices. An important note is that this excludes any Point of Care Tests (POCT), which have to be listed in the ARTG database before being legally marketed and provided
This exemption was issued to increase the availability of COVID-19 tests, after the TGA’s original exemption on 31 January allowed COVID-19 tests that were not yet approved and listed in the ARTG, to be used in laboratories in the Public Health Laboratory Network (PHLN). The two exemptions now allow tests in both public and private laboratories in Australia.
All other applications
TGA’s annual Key Performance Indicators (KPIs) are tied to being able to adequately manage the workflow even during these extreme circumstances. Their most recent self-assessment reflects the TGA’s effort to manage expectations. The latest self-assessment results published in December 2020 for the period July 2018 to June 2019, which are required to be certified by the Secretary of the Department of Health as the Accountable Authority under the Public Governance, Performance and Accountability Act 2013 and the Therapeutic Goods Act 1989.
Each year the annual self-assessment is reviewed by an external group of key industry stakeholders called the TGA Industry Forum (TIF) and both the self-assessment and the input from the TIF are published every year.
Below is the summary of the report’s result:
The TGA has consistently met the KPIs for many years. During 2019, they had only one KPI as “substantially met” meaning most KPIs are met, as opposed to “met” meaning all KPI’s met.
“KPI5: Regulators are open and transparent in their dealings with regulated entities” focuses on the effectiveness and openness to communicate with stakeholders. This KPI includes TGA’s main communication tools such as emails, calls, remote and in person meetings, website information, Facebook and a first contact point Regulatory Assistance Section (RAS) that manages the central inquiries line.
The during the reporting period RAS managed 24,220 telephone and email enquiries of which:
- 27% from industry and regulated entities;
- 22% from health professionals; and
- 41% from the public and the remainder from other stakeholders.
94% of all enquiries received by RAS during the reporting period met the timeframes outlined in the TGA Customer Service Standards, i.e. to acknowledge emails within five working days and respond to voicemail messages within two working days.
TGA has an excellent track record and is doing all they can to continue to support the evolving medical needs. We anticipate this will continue to be the case during these trying times.
If you are thinking of engaging with the TGA for a new application, emergency use application or other matters, please don’t hesitate to reach out to us. Our team has many of years of experience engaging with the agency and ensuring the workflow is as efficient as possible on all matters regulatory for the life-science industry.
If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)
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