This presentation provides an overview of the web publication of Australian Public Assessment Reports (AusPARs), including findings of the recent survey.

1. Transparency initiatives and the TGA
Dr Peter Papathanasiou
Transparency & Advisory Management Section
Prescription Medicines Authorisation Branch
Market Authorisation Division, TGA
ARCS Scientific Congress Canberra 2016

2. Two transparency initiatives
1. Web publication of Australian Public Assessment Reports (AusPARs):
a) Peer-reviewed review article in Drug Discovery Today co-authored with the European
Medicines Agency (EMA): published 29 June 2016
b) Survey findings on Australian public assessment reports (AusPARs): closed 31 July 2016
2. Web publication of recently registered:
a) new chemical entities
b) new or extended uses, or new combinations, of already registered medicines
before AusPAR is prepared.
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3. 1. Web publication of AusPARs
a) Peer-reviewed review article in Drug Discovery Today: published 29 June 2016
b) Survey findings: closed 31 July 2016
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4. https://www.tga.gov.au/australian-
public-assessment-reports-
prescription-medicines-auspars
• First AusPAR published Nov 2009 as part
of increased transparency strategy under
the Business Process Reforms for
prescription medicines
• Generally, AusPARs are prepared for
applications considered for entry, or
variation of entry, into the Australian
Register of Therapeutic Goods (ARTG)
where TGA has sought advice from its
Advisory Committee on Prescription
Medicines (ACPM)
3

5. AusPAR content
• Each AusPAR page contains three documents:
1) AusPAR itself, which includes summaries of TGA evaluation reports:
• Quality
• Nonclinical
• Clinical
• Risk Management Plan
• Delegate’s considerations (benefit-risk balance)
• ACPM’s considerations
• Outcome
Sponsor’s response
to Delegate’s
considerations
2) Extract from Clinical Evaluation Report (CER)
• CER redacted of commercially confidential information
3) Product Information (PI)
 Approved applications only
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6. https://www.tga.gov.au/publication/australian-public-
assessment-report-auspar-guidance-document
“This document provides
information about the
structure, and processes for
the compilation, review and
publishing of an AusPAR,
including guidance on the
principles for determining
what information is
commercially confidential.”
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7. Differences between
EPARs & AusPARs:
The view from EMA...
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8. The view from TGA...
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9. AusPAR content
• AusPAR structure was modelled on that of EPARs, with some differences:
– EPARs are published according to each medicine: initial EPAR published, then updates added
 AusPARs are published as separate reports according to each evaluation
– EPARs publish public-friendly Q+A document (“EPAR summary”) translated into 25 EU
languages
 AusPARs: do not publish summary
– EPARs publish all clinical information within document
 AusPARs: publish all clinical information in separate document (since July 2013)
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10. Transparency initiatives and the TGA 9

11. • To the end of 2015,
TGA had published
445 AusPARs for
378 individual
prescription
medicines
Average / year = 73
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12. • To the end of 2015,
EMA had published
1179 initial human
EPARs, along with
565 EPAR updates
(extensions of
indications)
Average / year = 83
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13. • Majority of published
AusPARs were for
new drug entities
(chemical or
biological) (35.4%)
and extensions of
indications (34.7%)
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14. • According to decision outcome:
‒ approved: n = 407
‒ withdrawn: n = 22
‒ rejected: n = 16
• TGA has published all types of decisions
from inception; EMA only began
publishing withdrawals & rejections from
1999
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15. Audiences for AusPARs
• Pharmaceutical industry
– Approx. 65% readers
• Other health authorities
• Other national medicines regulators
• Healthcare professionals & patients
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16. • TGA web trends indicate a steady
annual rise in visits to AusPAR
pages: from 0.74% in 2010 to
11.47% in 2014, a 15-fold increase
in 5 years
• EMA web trends shows that EPAR
pages are the most viewed pages
on the EMA website:
‒ Nov 2014: 8.90%
‒ Sep 2015: 10.36%
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17. AusPAR remains the
most viewed document
online, outperforming
Extract CER and PI
documents overall
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18. Although most AusPAR online
users are from Australia, there
is also substantial international
interest, particularly from the
US & China
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19. • Top five most viewed AusPAR documents online during 2010-2014:
World Health Organisation ATC codes:
N = Nervous system
G = Genito-urinary system and sex hormones
B = Blood and blood forming organs
Even though the most published
AusPARs have been for cancer drugs
(23%), the most viewed AusPARs are
for nervous system drugs (28%)
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20. Web traffic of individual
documents over time
showed that audience
interest was cyclical for
certain AusPARs, e.g.
spikes for influenza
vaccines during the
influenza season
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21. • AusPAR publication requires
resources but facilitates answering
requests for information or access to
documents.
• Today, about 1/3 requests for
information to TGA from healthcare
professionals and patients resulted in
reference to AusPARs, while about
1/4 requests to EMA were directed to
EPARs.
• Publication has also served as an
‘internal audit’, raising the bar for
readability of assessment reports.
Requests for information made to TGA during 2010-2015:
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22. “The full impact and
readership of EPARs
and AusPARs by
target audiences is
not currently
known...”
n = 105
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23. (Q) Which group best describes you?
3.8%
2.9%
10.5%
14.3%
3.8%
0%
67.6%
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24. (Q) Which documents do you mostly access?
83.8%
56.2%
64.8%
(Q) How often do you access AusPAR pages?
19.1%
54.3%
26.7%
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25. (Q) For which purpose do you use AusPAR information?
2.9%
11.4%
20.0%
4.8%
10.5%
50.5%
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26. (Q) How well do AusPAR documents serve their purpose of providing transparency of the
TGA’s decision process of prescription medicines?
38.1%
39.1%
20.0%
2.9%
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27. (Q) How useful are AusPAR documents for your needs?
36.2%
46.7%
15.2%
1.9%
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28. (Q) How likely are you to access AusPARs in the future?
68.6%
17.1%
11.4%
2.9%
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29. (Q) Do you have any further comments about AusPAR documents?
“I find AusPARs are an extremely
valuable tool for ensuring
transparency of TGA assessments.”
“Overall, documents are great.
A similar document should be
released for medical devices.”
“Definitely keep AusPARs. TGA needs
to ensure greater transparency in its
decision-making, not less.”
“Too much information is given in
AusPARs. I prefer AusPARs were
not published at all.”
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30. (Q) Do you have any further comments about AusPAR documents?
“The targeted time period for
publishing is not routinely met.
Timing can range from 2 to 12
months. It would be great to see an
improvement.”
“Publishing timeframes are
sometimes too slow for the purpose of
advanced consideration of practice
implications with new medications.”
“I would much prefer to see
AusPARs in EPAR format: a true
executive summary, rather than cut
and paste from evaluation reports.”
“A short, plain English summary
aimed at a non-technical audience
would be extremely useful.”
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31. (Q) Do you have any further comments about AusPAR documents?
“I think AusPARs are great. They are clearly a well thought-out, well structured
document. They are a substantive and meaningful improvement in making medicines
regulations more transparent. That said, I work as a medical division employee in a
pharmaceutical organisation. If I was a consumer, I think I would have difficulty in
understanding AusPARs. They are not written in ‘simple’ English and often include
highly technical medical information. If TGA’s objective is to publish documents for
the general public, then the current process could be improved to increase public
understanding and awareness. I genuinely believe we (all stakeholders) need to do
more about making the regulatory process more accessible to patients and the
general public. This would certainly raise awareness of the critical role TGA plays in
safeguarding the Australian community.”
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32. 2. Web publication of recently registered:
a) new chemical entities
b) new or extended uses, or new combinations, of already registered medicines
before AusPAR is prepared.
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33. https://www.tga.gov.au/subscribe-updates
26 Jul 2016
# subscribers:
246
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34. https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia
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35. https://www.tga.gov.au/prescription-medicines-new-or-extended-uses-registered-medicines
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36. auspars@tga.gov.au