PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey.

The majority of consumer, health professional and medical products industry respondents said they trusted the TGA to act ethically and with integrity. Most said the agency gets the balance right between access to therapeutic goods and safety for consumers. Respondents were satisfied with their interactions with TGA staff and systems, although they highlighted various areas for improvement, including user experience on the agency’s website.

The survey differentiates between two types of respondents: opt-in respondents who completed the survey by email or web link, and panel respondents who were recruited though a market research provider. Most of the panel respondents were consumers.

The TGA received 2,199 opt-in responses to the survey, with the majority (1,547) of those coming from drug and medical device industry stakeholders. Other groups included consumers, health professionals, university researchers, consumer advocates and government employees.

The annual stakeholder survey was developed to seek feedback on various aspects of the TGA’s role and how key stakeholders perceive that role. The survey was also designed to contribute to the TGA Regulator Performance Framework Self-Assessment Report, which evaluates the TGA’s work against key performance indicators in the Australian Government’s Regulator Performance Framework.

The TGA’s self-assessment report indicated that although TGA staff were diverted from their established business priorities in 2020 due to the COVID-19 pandemic, the agency was able to meet all its timelines for drug and device reviews.

TGA consultations beneficial

Participation in TGA consultations was greatest among drug and device industry respondents, with 31% participating compared to 5% of panel consumers and 4% of panel pharmacists.

Roughly 72% of the drug and device respondents who participated in a consultation over the past 12 months agreed that the TGA did enough to notify affected parties about the chance to participate, and 78% said the consultation process made it easy for them to participate. In addition, 75% said that consultation materials were easy to understand and that the timeframes for providing input were long enough.

However, fewer respondents agreed that the TGA genuinely considered their input. About half of respondents who participated in consultations said that the TGA clearly explained the reasons for the final outcomes. Still, 64% of drug and device industry stakeholders said they were satisfied with their overall consultation experience, compared to 12% who were dissatisfied.

For those who reported being dissatisfied, comments related to themes such as consulting with a broader range of stakeholders, increasing the length of consultation periods, listening to stakeholder feedback, and facilitating consultation processes more effectively.

Nearly 95% of drug and device stakeholders said they had contacted the TGA at least once during the year, and about 30% said they contacted the TGA about once a month. The top three reasons for contacting the agency were to lodge an application with the TGA (67%), check the progress of an application, (49%) or for information about manufacturing products (24%).

Roughly 72% of drug and device companies said they were satisfied with the TGA’s response to their inquiries. Some respondents conveyed difficulty with reaching TGA staff by phone.

TGA website needs work

Drug and device companies visited the TGA website with the greatest frequency, followed by panel pharmacists and panel consumers. About 30% of drug and device industry respondents indicated that they visit the TGA website more than once a week.

Those companies said the top three reasons for visiting the TGA website were to access guidance documents (75%), access TGA databases (73%) and to get information on fees (55%).

One-fourth of drug and device industry stakeholders said they had not visited the TGA’s business services (TBS) portal. Of those respondents who visited the TBS portal, the most common reasons involved lodging an application (57%), checking the progress of an application (47%) and varying or modifying an application (36%). Almost three-quarters of those stakeholders reported being satisfied with the portal.

Some respondents reported poor system performance, and some suggested a range of specific features and functions they would like to see improved, such as increased file size limits for uploads and clearer and faster confirmation of clinical trial notifications. Some expressed difficulty with logging-in to the TBS portal, stating that password resets were too frequent.

The TGA said the Australian government was investing AU$12 million over four years to modernize the TGA’s business systems and infrastructure. Funding for the TGA’s digital transformation projects will come from the TGA’s special account reserves, and ongoing maintenance and support costs will be subject to fees and charges levied on sponsors and drug and device manufacturers.

The TGA offers a service to support small and medium enterprises called SME Assist to help startups and those unfamiliar with regulation to better understand their regulatory obligations. Roughly 44% of SME respondents were aware of the service, and about 44% of those who were aware of the service had accessed the portal. About 18% had attended a SME Assist event, such as a workshop or webinar. Nearly 53% of respondents who were aware of SME Assist agreed that the service is targeted and useful.

Among drug and device industry respondents, 38% said they advertise or arrange the advertising of therapeutic goods. Of that group, 97% said they were aware of specific rules for advertising therapeutic goods in Australia. And about 98% said they were aware of potentially serious consequences for breaking those rules, such as fines and court action.

What can the TGA do better?

Drug and device stakeholders had a range of suggestions for areas in which the TGA could improve. Some said that fees and charges were too high, and some sought faster decision-making and processing of applications. Others requested more guidance and assistance to help them understand the regulatory framework. Enforcing the regulations to ensure safety and a level playing field was also a notable theme.

One industry stakeholder said that ongoing TGA product fees for companies with small turnovers is “onerous,” and there should be some sort of scaled fee relating to overall company turnover. Another stakeholder said that more staff should be available to help new participants to navigate processes and regulations contextually.

One respondent said that more clarity on decision-making criteria was needed as well as faster decisions in the time of the pandemic and beyond.

One industry sponsor said the TGA should be more vigorous in pursuing companies who make therapeutic claims on labeling or in advertising products that are not registered or where there is inadequate evidence to support claims being made.