The extended partnership will see TGA fund ANDHealth to deliver industry-wide training to over 350 participants from the Australian digital health sector in the next 12 months. The program includes 10 virtual workshops and over 150 hours of direct one-to-one coaching for digital health SMEs seeking to navigate Australia’s Software as a Medical Device (SaMD) regulatory environment, supporting them to accelerate the commercialisation of their products.
The announcement is in response to the growing investment from global governments, pharmaceutical companies, and healthcare providers into digital health solutions, and an increased focus from regulators on the clinical claims made by these new innovations.
ANDHealth CEO and Managing Director Bronwyn Le Grice said, “Pursuing appropriate regulatory pathways can be a real strategic advantage for companies both locally and globally. Global regulators are increasingly focusing on clinical claims made by digital health products and, as with any clinical claim, it’s critical that a company has appropriate evidence to substantiate those claims. In fact, for customers and users, it’s a prerequisite that digital health products can point to their safety and efficacy.”
“Our partnership with the TGA puts Australia’s emerging digital health innovators in the best position to effectively navigate the regulatory environment and pursue clinical programs that make their ground-breaking health technologies globally marketable.”
Since September 2021, ANDHealth and the TGA have supported 192 companies to increase their understanding of regulatory requirements, including the type of evidence required when seeking regulatory approval with the TGA, when regulatory approval is not required, how to list a device on the Australian Register of Therapeutic Goods (ARTG), and the differences between Australia and other international markets.
Le Grice continued, “There has been positive progress for Australia’s digital health regulatory environment since the TGA released its draft guidance for SaMD in 2020. This established a clear regulatory path for evidence-based digital health products. Our partnership with the TGA has demonstrated that digital health companies benefit from targeted and qualified support to understand the regulatory environment in which they operate.”
Adjunct Professor John Skerritt, Deputy Secretary of Health and Head of the TGA said, “Australia is seeing a shift toward the adoption of evidence-based digital health interventions to help prevent, manage and treat health conditions. To meet this increasing demand, and set Australia’s digital health industry up for success, we must equip companies with skills to navigate the regulatory landscape of the products they are developing. We are delighted to continue our collaboration with ANDHealth to support this.”
In the first six months of the partnership, every webinar offered by ANDHealth under the partnership was booked out; 94 per cent of participants agreed that the one-on-one coaching they received increased their ability to navigate either the SaMD regulations or the regulations pertaining to their digital health solution or both; 97 per cent said the program increased their knowledge of SaMD regulation.
For more information about ANDHealth’s partnership with the TGA, visit andhealth.com.au/partners/tga.