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TGA stakeholder survey 2018

20 December 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

In the last 12 months, have you been involved in any of the following activities conducted by the TGA?
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
Figure 60: Involvement in TGA activities (N)
Column chart of Table 44 data
Table 45: Involvement in TGA activities - Number of activities
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)

Which consultations were you involved with during the last 12 months?
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)

Which event(s) did you attend in the last 12 months?
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 (%)

How satisfied were you with the following features of the event(s) you attended?
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.

Figure 61: Consultations - Nett satisfaction - 2016-2018 (%)
Line chart - see Figure 61 in tabular format

N=147-394

Figure 61: Consultations - Nett satisfaction - 2016-2018 (%)
Event feature 2018 2017 2016
Consultation procedures 70 66 67
Information provided in the consultation documents 75 76 74
Simplicity of the consultation processes 68 65 67
Follow up on consultation processes 51 49 47
Ability to provide input and feedback on the consultation 69 71 67
Overall satisfaction with Consultations 69 67 63

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.

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