Version 1.0, November 2016
Australian Public Assessment Reports (AusPARs) relate to the TGA's pre market assessment of a prescription medicine application. As the TGA receive thousands of applications each year, AusPARs are only prepared in relation to applications for products containing a new active ingredient or for new therapeutic uses or major variations to registered products. AusPARs contain extracts from the TGA's reports that were prepared as part of the registration process and, as such, document the considerations that led to the approval, or otherwise, of an application.
The survey was to help the TGA identify the audience for AusPARs, understand what AusPARs were being used for and determine how useful their content was to external stakeholders.
This survey was for anyone who uses AusPARs including health care professionals, the pharmaceutical industry and consumers. The survey was available online via the AusPAR page on the TGA website.
The survey was open from 2 May 2016 to 31 July 2016.
The survey contained 11 questions of which 3 were optional and 8 mandatory.
Version 1.0, November 2016
There were a total of 105 respondents to this survey.
The absolute numbers of responses to each question are detailed in Appendix 1.
There were 84 responses to this question. This question was optional.
There were 83 responses to this question. This question was optional.
Of the 83 responses, the vast majority (n=71, 86%) were from the pharmaceutical industry. Question 3 below gives a more detailed description of the survey respondents.
There were 108 responses to this question. Respondents could provide more than one response. This question was mandatory.
The majority of survey respondents (68%) were from the pharmaceutical industry (Figure 1). A much lower percentage (10-14%) comprised health care professionals or government employees. Nearly 4% were medicines regulators. No responses were obtained from those in the media.
There were 105 responses to this question. This question was mandatory.
The majority of respondents were from Australia (90%; Figure 2), with a small number of respondents from Singapore (n=4), the USA (n=3), India (n=2) and Spain (n=1).
There were 215 responses to this question. Respondents could provide more than one response. This question was mandatory.
Although most respondents said they accessed the AusPAR itself (83%; Figure 3), 56 65% said they also accessed the Extract from the Clinical Evaluation Report (CER) and/or the Product Information (PI) document.
There were 105 responses to this question. This question was mandatory.
The majority of respondents (54%) accessed AusPARs only when they were published on certain drug classes (Figure 4). Nineteen per cent of readers said they accessed AusPAR pages every time a new AusPAR was published. Just over a quarter of the responders (27%) rarely accessed the AusPAR pages.
There were 105 responses to this question. This question was mandatory.
A small number of respondents reported that they used AusPARs for academic research or medical practice interest (3-5%), while a slightly higher number declared that they used AusPARs for government related work or personal interest (10-11%).
The majority of respondents to this question answered that they used AusPAR information for a category 'Other' than those listed (50.5%; Figure 5). Out of these 'Other' responses, about 40% said they used the information for 'regulatory intelligence', that is, to understand dossier issues, to gain insights into the regulatory decision-making process, and to understand the course of evaluations and trends in the TGA's perspective on drug development programs and regulatory decision making. It was also mentioned that AusPARs were used to understand regulatory hurdles faced by other companies when seeking to register similar therapeutic products.
Approximately thirty per cent of responses said that AusPAR information was used for writing medicines information; to inform clinical and economic evaluations, training, teaching and research; as a reference or guide to new medicines use and administration; and to keep up to date with new approvals and new indications.
A smaller number (-20%) of the 'Other' responses described AusPAR information being used as 'competitor intelligence', that is, to gain regulatory information on competitors and the competitors' data submitted to the TGA.
There were 105 responses to this question. This question was mandatory.
Nearly 80% of the respondents felt that AusPAR documents served their purpose of providing transparency of the TGA's decision-making processes of prescription medicines very well or well (Figure 6). One fifth of the respondents felt that AusPARs only somewhat fulfilled this purpose. Three per cent of responders felt that AusPAR documents did not fulfil this purpose at all.
There were 105 responses to this question. This question was mandatory.
Eighty-three per cent of the respondents answered that AusPAR documents were very useful or useful to their needs (Figure 7). Fifteen per cent felt they were somewhat useful, and 2% felt they were not useful at all.
There were 105 responses to this question. This question was mandatory.
Seventy per cent of respondents said they were very likely to access the information contained in AusPAR documents in the future (Figure 8). Seventeen per cent responded that they were likely to use AusPAR documents again, and 11 % that they were somewhat likely. A small number (3%) responded they were unlikely to access the information in AusPARs again.
There were 44 responses to this question. This question was optional. Of the 44 responses, nearly a quarter (n = 10, 23%) said that they would like to see a plain English, consumer-friendly summary included with each AusPAR.
Eight survey responders (18%) would like to see an improved AusPAR structure or a more detailed description of the decision and the rationale for the outcome, particularly where rejections and appeals are described in an AusPAR. It was also mentioned that a submission's chronology could be better presented, for example, questions raised by the evaluator should be followed by the sponsor's responses and TGA's resolutions in the same space. This would avoid the reader having to go through the whole document to find answers and resolutions.
Sixteen per cent (n = 7) of comments raised the unpredictability of AusPAR publication timing.
Eight respondents included suggestions for improvement and more information they would like to see in AusPARs, for example, details of PI negotiations, details of publications of clinical trials, application submission dates, and more information on quality and nonclinical data. One responder also proposed TGA publish AusPARs for medical devices.
Two survey respondents raised the issue of commercially confidential information being included in AusPARs,[1] while one respondent was concerned about the prospect of industry influencing AusPAR content.[2]
One response stated that they would prefer for AusPARs not to be published.
Four responders commented that AusPARs were useful, well presented, and showed good transparency of the TGA's decisions.
Two survey responders also identified improvements that could be made to the AusPAR landing page on the TGA website. Currently, AusPAR documents are only identified by a date and a broad description of the application type, which makes it difficult to identify AusPARs for a particular indication or variation without accessing individual documents.
Other respondents commented on the quality and nonclinical aspects of AusPARs, Orphan Drug Designation, and PI documents.
The majority of AusPAR readers were from the Australian pharmaceutical industry. A much smaller number were health care professionals, government employees or medicines regulators.
In line with the majority of AusPAR readers being from the pharmaceutical industry, the majority of respondent accessed AusPARs only when AusPARs on certain drug classes were published. This information was subsequently used to gain insight into the TGA's regulatory decision-making process, trends in the TGA's perspective on drug development programs, and to gain regulatory information on competitors and their data submitted to the TGA. AusPAR information was also used to keep current with new medicines and indications, as well as writing medicines information, training/teaching, and conducting research into prescription medicines. All three published documents - the AusPAR itself, Extract CER, and PI - were regularly accessed and considered useful by most readers.
The vast majority of survey respondents said that AusPAR documents adequately served their purpose of providing transparency into the TGA's decision making process for prescription medicines, were useful to the person's needs, and that they would continue to access again AusPARs in the future. A smaller number of respondents accessed AusPAR pages only when a new AusPAR was published, presumably when they received an update via the AusPAR email notification list.[3]
The TGA is currently considering the suggestions for the improvement of AusPAR documents. This includes including a plain English and more consumer-friendly summary along with more details of the rationale for the decision in the AusPAR. Rather than changing AusPAR format to address the issue raised regarding chronology, TGA has been, and will continue to be, open to the inclusion of footnotes in the AusPAR to inform readers if an issue raised in the evaluation was later resolved so that the reader does not have to go through the whole document to find the answer.
The TGA is currently implementing methods to improve the timing of AusPAR publications.
The TGA is also considering making improvements to the AusPAR pages on the TGA website. Improvements may include providing more detailed information on the landing page of individual AusPARs to help readers identify different applications for the same product, and classifying AusPARs according to distinctive disease classes treated.
Version 1.0, November 2016
Category | Total (n) |
---|---|
Academic | 4 |
Consumer/Patient | 3 |
Government | 11 |
Health Care Professional | 15 |
Medicines Regulator | 4 |
Media | 0 |
Pharmaceutical Industry | 71 |
Category | Total (n) |
---|---|
Australia | 95 |
Other - please specify | 10 |
Category | Total (n) |
---|---|
AusPAR | 88 |
Extract from the Clinical Evaluation Report (CER) | 59 |
Product Information (PI) | 68 |
Category | Total (n) |
---|---|
Every time a new AusPAR is published | 20 |
Only when AusPARs on drugs from certain classes are published (e.g. cardiovascular) | 57 |
Rarely | 28 |
Category | Total (n) |
---|---|
Academic research | 3 |
Government related | 12 |
Market research | 21 |
Medical prescriber interest | 5 |
Personal interest | 11 |
Other – please specify | 53 |
Category | Total (n) |
---|---|
Very well | 40 |
Well | 41 |
Somewhat | 21 |
Not at all | 3 |
Category | Total (n) |
---|---|
Very useful | 38 |
Useful | 49 |
Somewhat useful | 16 |
Not at all useful | 2 |
Category | Total (n) |
---|---|
Very likely | 72 |
Likely | 18 |
Somewhat likely | 12 |
Unlikely | 3 |
Version 1.0, November 2016
Version | Description of change | Author | Effective date |
---|---|---|---|
V1.0 | Original publication | Therapeutic Goods Administration | 07/11/2016 |