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TGA stakeholder survey 2018
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TGA activities - Information sessions, Consultative processes and Events
Involvement in TGA activities
A total of 692 participants in the survey highlighted involvement in activities conducted by the TGA in the last 12 months (Table 44 and Figure 60). This represents around 37% of respondents to the question. The most common participation was in the form of a Consultation process (414), Information session (368) or Webinar (301). While the most common response amongst those who have participated is to select a single form of participation, many of those who identified participation in the identified events highlighted more than one activity, with an average of 2.1 selections (Table 45).
Table 44: Involvement in TGA activities
Activity | N |
---|---|
Consultative processes (e.g. responding to consultation documents) | 414 |
TGA exhibition/booth (e.g. as a visitor at a conference) | 172 |
Information session | 368 |
Webinars | 301 |
Workshops | 227 |
No - I have not been involved in any of these activities | 1164 |

Number of activity selections | N |
---|---|
1 | 280 |
2 | 175 |
3 | 128 |
4 | 77 |
5 | 32 |
No - I have not been involved in any of these activities | 1164 |
Total answering | 1856 |
Average (excluding not involved) | 2.1 |
Activities
A range of specific participation in consultations and events is identified. Involvement levels identified are shown in Tables 46 and 47.
Table 46: Participation - Consultations (N)
Consultation | N |
---|---|
Therapeutic Goods Advertising Code | 127 |
Proposal to change the current good manufacturing practice (GMP) fees and charges | 121 |
Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017 | 112 |
Draft therapeutic goods advertising code 2018 and associated guidelines | 105 |
Advertising therapeutic goods to the public | 88 |
Consultations on adoption of European Union guidelines in Australia | 79 |
Management and communication of medicines shortages | 64 |
Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS | 55 |
Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS | 55 |
Business process improvements supporting complementary medicines assessment pathways | 44 |
Alignment with European medical device regulatory framework- Up-classification of surgical mesh & Patient implant cards | 43 |
Options for the implementation of a claimer for efficacy assessed non-prescription medicines | 39 |
Scheduling delegate's interim decisions & invitations for further comment | 38 |
Nomenclature of Biological Medicines | 33 |
Proposed regulatory changes related to personalised and 3D printed medical devices | 33 |
Remaking of TGO No. 77 - Microbiological Standards for Medicines | 31 |
Prescription strong (Schedule 8) opioid use and misuse in Australia - options for a regulatory response | 27 |
Discontinuing pre-market evaluation of Herbal Component Names (HCNs) | 26 |
Revision of TGO 75 Standard for haematopoietic progenitor cells derived from cord blood | 13 |
Sedating antihistamines: proposed additional advisory statements for medicines | 10 |
Miconazole and fluconazole: proposed advisory statements for medicines | 7 |
Other, please specify | 58 |
Table 47: Participation - Events (N)
Event | N |
---|---|
Webinar: Update on the Advertising Therapeutic Goods Reforms - 23 May 2018 | 148 |
Webinar: The new Code - Where are we at, 12 Jun 2018 | 70 |
Information session: The new Code - Where are we at? - Sydney, 13 Jun 2018 | 64 |
TGA booth: RACP - Sydney, 14 - 16 May 2017 | 10 |
Other | 135 |
In addition to the events listed in the survey, participants also highlighted a range of "Other" involvement with the TGA. This includes the following specific events and consultations:
Events
- Risk management.
- Auditing.
- 3D printing.
- ARCS sessions and webinars.
- NHMRC webinar.
- BAA conference.
- CMA reform information session.
- Fees and charges information sessions.
- Complementary medicines reform workshop.
- GMP forum.
- Pharmacovigilance inspections.
- FOI information seminar.
- External evaluator panel information session.
- Inspection program workshop.
- ISCT meetings.
- MMDR information session.
- CORS pathway.
- Stem cells registration.
- Permitted indications workshop.
- Sponsor information day.
- TGA information day.
- Webinars - general.
Consultations
- Black triangle scheme.
- Adverse events reporting.
- Advertising compliance.
- Australian clinical trial handbook.
- Autologous cell therapies.
- Classification of Leukaemia and Lymphoma Products (IVD).
- Communication plan for patients and health professionals on priority and provisionally registered medicines.
- Comparable overseas regulators - medical devices; enhancing sanctions and penalties in the Therapeutic Goods Act 1989; Options for the future regulation of 'low risk'.
- Complementary medicines reforms.
- Biologicals.
- Genetically modified organism consultation.
- Ibuprofen and Codeine rescheduling.
- Labelling.
- National statement updates.
- NMBA.
- Permitted indications.
- Pharmacovigilance guidelines.
- Registration and fees.
- Review of device to replace existing device.
- Risk management plans.
- SAS.
- Australian Clinical Trial Handbook.
- Neuromuscular blocking agents.
Satisfaction with activities
Satisfaction across a range of statements relating to events highlights generally strong levels of satisfaction across Consultations booths, Information sessions and Webinars (Table 48). Amongst those who have participated in consultations, there is a high level of satisfaction with the information provided (Nett satisfaction 75%). For the remaining measures, two thirds or more express satisfaction with the procedures, simplicity of the process, ability to provide input and feedback and overall satisfaction with consultations. Follow up on consultation processes is rated less favourably, with just over half of the participating group highlighting satisfaction. Despite the overall strong levels of satisfaction, opportunities to minimise the level of dissatisfaction are identified, with more than 10% of people highlighting dissatisfaction on the overall satisfaction measure and the ability to follow up on consultation processes. Small sample sizes make interpretation of further breakdowns by stakeholder category difficult; however, a general trend toward lower levels of satisfaction amongst Health professionals compared to those in the Medical products industry is noted.
Table 48: Satisfaction with Events (%)
Statement | Nett dissatisfied | Neither | Nett satisfied | N |
---|---|---|---|---|
Consultations | ||||
Consultation procedures | 9.1 | 21.2 | 69.6 | 372 |
Information provided in the consultation documents | 7.2 | 17.4 | 75.4 | 374 |
Simplicity of the consultation processes | 8.1 | 23.8 | 68.1 | 370 |
Follow up on consultation processes | 13.6 | 35.2 | 51.2 | 369 |
Ability to provide input and feedback on the consultation | 8.6 | 22.6 | 68.8 | 372 |
Overall satisfaction with Consultations | 12.6 | 18.6 | 68.9 | 350 |
TGA booth | ||||
Information provided in the TGA booth | 2.8 | 21.3 | 75.9 | 108 |
Quality of the TGA booth | 3.7 | 16.7 | 79.6 | 108 |
Overall satisfaction with TGA booths | 2.8 | 15.1 | 82.1 | 106 |
Information sessions | ||||
Information provided during the information session | 8.1 | 16.1 | 75.8 | 62 |
Quality of the Information session | 6.6 | 23.0 | 70.5 | 61 |
Overall satisfaction with Information sessions | 6.7 | 15.0 | 78.3 | 60 |
Workshops | ||||
Quality of the workshop | 1.7 | 0.0 | 98.3 | 59 |
Overall satisfaction with the workshop | 1.8 | 3.6 | 94.5 | 55 |
Webinars | ||||
Information provided during the webinar | 9.3 | 19.7 | 71.0 | 183 |
Overall satisfaction with the webinar | 9.8 | 19.7 | 70.5 | 183 |
Across years, ratings of consultations show strong consistency. Nett satisfaction scores, shown in Figure 61 below, generally show a trend toward slight increases in Nett satisfaction since 2016. Encouragingly, the overall satisfaction with consultations has increased from 63% in 2016 to 69% in the 2018 survey.

N=147-394
For those who have experienced TGA booths, the feedback is generally positive, with good levels of Nett satisfaction observed across Information provided (76%), Quality (80%) and Overall satisfaction (82%) measures (Table 48). These outcomes are accompanied by very low dissatisfaction levels of 4% or lower. Information sessions are viewed slightly less favourably; however, the overall performance in relation to these events remains strong, with between 71% and 78% Nett satisfaction across the three measures identified and generally low levels of dissatisfaction (under 10% on all measures).
Ratings on workshop events are very positive. Almost all participants express satisfaction with the quality of the workshop. Overall satisfaction is similarly high. On both measures, only one of the identified participants in workshops highlighted dissatisfaction with the event they attended. The in-person context of the workshop may help to explain the less favourable outcomes in relation to webinars events, which showed less favourable (although still generally positive) outcomes. Around seven in ten webinar participants expressed satisfaction with both the information provided and the overall event, with around 1 in 10 dissatisfied. Inviting direct and immediate feedback on these events may assist in refining the experience of participants over time.
Due to the very small numbers of respondents, comparison of outcomes across stakeholder categories in relation to booths, information sessions, workshops and webinars is not reliable.