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TGA stakeholder survey 2017

26 April 2018

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TGA activities - information sessions, consultative processes and events

Involvement in TGA activities

A total of 608 participants in the survey highlighted involvement in activities conducted by the TGA in the last 12 months (Table 48 and Figure 75). This represents around just over three in ten responses to this question. The most common participation was in the form of a consultation process (441) or information session (366).

Table 48: 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) 441
Exhibitions (e.g. TGA booth at conference) 76
Information sessions 366
No - I have not been involved in any of these activities 1347

Figure 75: Involvement in TGA activities

Column chart of Table 48 data

Most participants who highlight participation, indicate involvement in a single activity, however just fewer than 4 in 10 had participated in more than one activity (Table 49).

Table 49: Involvement in TGA activities - Number of activities

Number of activity selections n
1 373
2 195
3 40
Average 1.5

Activities

A range of specific participation in consultations and events is identified. Involvement levels identified are shown in tables 50 and 51.

Table 50: Participation - Consultations (N)

Which consultations were you involved with during the last 12 months?
Consultation N
Changes to accessing unapproved therapeutic goods 130
Expedited pathways for prescription medicines 118
Options for the future regulation of low risk products 107
Criteria for comparable overseas regulators 106
Provisional Approval pathway for prescription medicines 106
Accelerated assessment of medical devices: Priority review pathway 101
The Regulatory framework for advertising therapeutic goods 98
Reforms to the regulatory framework for complementary medicines 97
Orphan drug program 87
Risk management plans for medicines and biologicals 84
Strengthening monitoring of medicines in Australia - enhanced medicines vigilance 81
Comparable overseas regulators - medical devices 81
Designation of Australian conformity assessment bodies for medical devices 54
TGA - enhancing sanctions and penalties in the Therapeutic Goods Act 1989 46
Guidance on variations to biologicals included in the Register 44
NSAID medicines: proposed advisory statement 33
Regulation of autologous cell and tissue products 29
Biovigilance responsibilities of sponsors of biologicals 29
Paracetamol and Ibuprofen: advisory statements for medicines 28
Scheduling Policy Framework & advertising controls of Pharmacist-only medicines review 25
Therapeutic Goods Order No 93 - Standard for Medicinal Cannabis 20
Revision of TGO 75 standard for HPCs derived from cord blood 11
Other 52

Table 51: Participation - Events (N)

Which event(s) did you attend in the last 12 months?
Event N
ARCS Scientific Congress (Canberra) - 10 August 2016 156
15th World Congress on Public Health 2017 (Melbourne) - 3 April 2017 11
Other 131

In addition to the events listed in the survey, participants also highlighted a range of "Other" involvement with TGA. This includes the following specific contacts and events:

Events

  • ARCS Sessions
  • Ausbiotech
  • Biotherapeutics Association of Australasia Workshop
  • CMA information day
  • Codeine forum
  • Department of health and Human Services Annual Workshop
  • eform workshops
  • IRIS information session
  • ISCT event
  • Medical device training/workshop
  • Minor variation workshop
  • MTAA conference
  • Post market training and workshops
  • RMP workshops
  • Webinar events

Consultations

  • Post market survey
  • Application processes
  • Authorised prescriber scheme
  • Special access schemes
  • Clinical guidelines
  • Clinical trials
  • Compounding guidelines
  • Data on sunscreen products
  • EDI initiative
  • Minor variations
  • IVD
  • Labelling
  • Medicinal cannabis
  • Medicines shortages working group
  • Pharmacovigilance
  • Scheduling consultations

Satisfaction with activities

Respondents were asked to highlight their satisfaction with a range of statements relating to the events they had participated in (Table 52). Satisfaction with consultations remain generally positive, with most measures consistent with the previous year's findings. Importantly, very few people are dissatisfied. Notable outcomes here include a rise in the satisfaction with the ability to provide feedback (Nett satisfaction 2017 71%; 2016 67%), strong satisfaction with the information provided throughout the consultation process (76%) and a continued generally low satisfaction with follow up processes (49% Nett satisfaction).

Feedback on exhibitions remain strong, with the quality and overall satisfaction with the exhibitions both observed at 72% Nett satisfaction. Satisfaction with the informativeness of exhibitions fell from 75% in 2016 to 68% in 2017. This reflects a general trend across these measures for slightly lower outcomes in comparison to ratings of exhibitions in 2016.

Table 52: Event satisfaction - 2016 vs 2017 (%)

How satisfied were you with the following features of the event(s) you attended?
Feature Nett Dissatisfied Neither Nett Satisfied Nett Dissatisfied Neither Nett Satisfied Change Nett Satis
2017 2016
Consultation procedures 7 27 66 10 23 67 -1
Information provided in the consultation documents 6 18 76 7 19 74 2
Simplicity of the consultation processes 8 27 65 10 23 67 -2
Follow up on consultation processes 14 36 49 22 31 47 2
Ability to provide input and feedback on the consultation 8 21 71 9 25 67 5
Informativeness of the Exhibition 2 30 68 0 25 75 -7
Quality of the Exhibition 2 26 72 0 25 75 -3
Overall satisfaction with Consultations 8 26 67 12 25 63 4
Overall satisfaction with Exhibitions 3 25 72 0 25 75 -3

N=147-394

Satisfaction with consultations varies markedly across stakeholder categories, however the small sample sizes in all except the Health professional and Medical products industry categories make comparison difficult (Tables 53-55). Consistent with the 2016 findings, there is a slight tendency for those in the Medical products industry to show slightly higher satisfaction and lower dissatisfaction than health professionals. This is the case in relation to Information provided in the consultation documents, Simplicity of processes, Ability to provide input and feedback on the consultation and Overall satisfaction.

Due to the very small numbers of respondents in all except the Medical products industry category, comparison of outcomes across stakeholder categories in relation to exhibitions is not reliable.

Table 53: Event satisfaction - Consultations - by Stakeholder category - Part A

How satisfied were you with the following features of the event(s) you attended?
Professional category Consultation procedures Information provided in the consultation documents Simplicity of the consultation processes Follow up on consultation processes
Nett Dissatisfied Nett Satisfied Nett Dissatisfied Nett Satisfied Nett Dissatisfied Nett Satisfied Nett Dissatisfied Nett Satisfied
Total 7 66 6 76 8 65 14 49
Health professional 7 64 7 67 14 55 16 47
Community member - - - - - - - -
Medical products industry 7 67 5 77 7 67 13 52
Retailer 0 100 0 100 0 75 0 50
Government 13 38 0 75 0 50 13 25
Academic 0 67 0 83 0 83 17 67
Media - - - - - - - -
Other 10 66 10 76 12 58 25 42

Health pro: N=6-45; Community: N=0-0; Med prod ind: N=116-281; Retailer: N=1-4; Gov: N=3-8; Academic: N=4-6; Media: N=0-0; Other: N=17-50.

Table 54: Event satisfaction - Consultations - by Stakeholder category - Part B

How satisfied were you with the following features of the event(s) you attended?
Professional category Ability to provide input and feedback on the consultation Informativeness of the Exhibition Quality of the Exhibition
Nett Dissatisfied Nett Satisfied Nett Dissatisfied Nett Satisfied Nett Dissatisfied Nett Satisfied
Total 8 71 2 68 2 72
Health professional 10 59 0 100 0 100
Community member - - - - - -
Medical products industry 7 74 2 67 2 69
Retailer 25 50 0 0 0 0
Government 0 63 33 67 33 67
Academic 0 83 0 75 0 75
Media - - - - - -
Other 12 69 0 71 0 82

Health pro: N=6-45; Community: N=0-0; Med prod ind: N=116-281; Retailer: N=1-4; Gov: N=3-8; Academic: N=4-6; Media: N=0-0; Other: N=17-50.

Table 55: Event satisfaction - Consultations - by Stakeholder category - Part C

How satisfied were you with the following features of the event(s) you attended?
Professional category Overall satisfaction with Consultations Overall satisfaction with Exhibitions
Nett Dissatisfied Nett Satisfied Nett Dissatisfied Nett Satisfied
Total 8 67 3 72
Health professional 12 57 0 100
Community member - - - -
Medical products industry 8 68 2 72
Retailer 0 67 0 0
Government 0 57 33 67
Academic 0 83 0 50
Media - - - -
Other 6 65 6 71

Health pro: N=6-45; Community: N=0-0; Med prod ind: N=116-281; Retailer: N=1-4; Gov: N=3-8; Academic: N=4-6; Media: N=0-0; Other: N=17-50.

Survey participants were invited to provide comments and suggestions in relation to TGA consultation, training, seminars and events. A total of 432 comments were received, covering a broad range of focus areas.

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