PERTH, Australia – Although industry rated Australia's Therapeutic Goods Administration (TGA) high when it comes to performing its role ethically and with integrity, the agency has a ways to go when it comes to communicating with its stakeholders, a recent survey suggests.

The survey, which measured the agency's performance across a number of key performance areas, was sent to TGA stakeholders in July; it received 2,797 responses from TGA stakeholders, indicating a 15 percent response rate.

Of those respondents, 69 percent (1,634) represented drug or device companies, 19 percent (449) were health care professionals, 7 percent (169) were retailers and 6 percent (146) were academics.

Of the drug and device industry respondents, 1,187 were product sponsors, 775 were product manufacturers, 276 were regulatory affairs consultants and 85 were industry association representatives. The majority of respondents represented small companies with less than 20 employees.


"A key strength of the TGA to emerge in the findings was the strong levels of trust and reputational outcomes," the survey said, noting that 85 percent of respondents said the agency performs its role ethically and with integrity, and 73 percent said the TGA is regarded well internationally.

Stakeholders in the drug and device industry showed higher confidence in the TGA for measures such as trustworthiness than did community-focused groups. That area is also seen as one where there is opportunity for improvement, and the agency plans to focus on early communication and feedback.

When asked whether Australia gets the balance right between risks and benefits associated with therapeutic goods and if the TGA manages risks appropriately, two-thirds of respondents were overall positive on the agency's risk management.

Overall confidence in the TGA was measured across a range of focus areas. When it came to technical competence, there was a 61 percent net confidence rating, compared to a 12 percent net low confidence rating.


There was a fair amount of disagreement among stakeholders when it came to measuring the agency's performance for collaboration, consultation and feedback.

Although the majority of stakeholders said they were able to provide feedback to the agency, many said the agency needs to do a better job around the "timeliness of consultation, listening to feedback, providing opportunities for input and collaboration."

Those who said there were not enough opportunities to engage with the TGA were also concerned about the range of feedback channels available.

There was generally low agreement across all groups that the TGA listens to feedback. Outcomes here were particularly low among those in the retailer and community categories. Less than half of respondents across all major stakeholder groups felt that the TGA was collaborative.

Interestingly, communication was an area in which the TGA rated itself as having "substantially met" its goals in its own self-assessment on key performance indicators. That self-assessment was released days before the stakeholder survey.

In the TGA's self-assessment, the agency said it believed its communication with stakeholders was clear, targeted and effective. It pointed to new guidance documents developed and progress in meeting target goals for premarket applications and postmarketing activities. The agency also launched a TGA Twitter channel in November 2015 to improve its communication channels.

The survey suggests that there are opportunities for improving the timeliness of consultations and perceptions of the organization when it comes to collaboration.


There was a wide discrepancy when it came to how stakeholders communicate with the agency and whether that communication is effective.

The dominant method of communication for most stakeholders was the TGA's website and its business portal. The agency said that the variation highlighted the need for more tailored communication among various stakeholders.

More than 80 percent of respondents reported using the TGA's business services portal, and the most common reason to access the site was to lodge applications or check application status. Two-thirds of those respondents indicated overall satisfaction with the site.

The most common reason for visiting the TGA website was to search guidance documents, access databases and seek information on fees. Satisfaction with the website overall was fairly high, with 69 percent reporting overall satisfaction. Dissatisfaction was highest among government, community and academic stakeholders.

When asked how satisfied stakeholders were with their communication experience with the TGA overall, the survey indicated a net satisfaction rate of 63 percent compared to a net dissatisfaction rate of 15 percent.

Satisfaction was strongest among government representatives and drug and device companies, and it was lowest among health care professionals. Notably, satisfaction was rated highest for phone inquiries.

"The contact method with the fastest average resolution time was via the phone, with just under three in 10 highlighting immediate response and 83 percent experiencing a response in two days or less," the survey said.

Website contacts also showed strong response levels, with 10 percent achieving an immediate response and 58 percent receiving a response in two days or less. Similarly, email response times were relatively strong, with 55 percent response levels within two days.

Face-to-face communication was relatively low among industry stakeholders, with only one-fourth of respondents reporting they had attended a TGA event or activity, which included information sessions, consultations and other activities.

In its own self-assessment, the agency noted that it participated in 81 formal stakeholder forums in the last year. Those forums included workshops, presentations, regular working group meetings and stakeholder meetings.