The document discusses several regulatory reforms for listed medicines in Australia, including: 1. Permitted indications which provide a list of approved health benefit claims for listed medicines and require sponsors to select from this list, improving transparency. 2. An assessed listed pathway which allows pre-market evaluation of efficacy claims, providing access to higher-level health claims. 3. A "TGA assessed" label claim indicating the medicine's efficacy has been evaluated, improving consumer awareness and confidence. 4. Two years of market exclusivity for sponsors who apply for and are approved for new permitted ingredients.

1. Regulatory updates from the Complementary and OTC
Medicines Branch
Listed medicines regulatory reforms
Michael Shum
Director, Business Improvement and Support Section
Complementary and OTC Medicines Branch
2019 ARCS Annual Conference
6 August 2019

2. Objectives of the listed medicines regulatory reforms
Industry Consumers
Transparency
about evidence
Improve the
evidence base
Improve
compliance
Incentivise
innovation
Improve flexibility
and predictability
Simplify the listing
system
Regulatory updates from the Complementary and OTC Medicines Branch

3. Staged implementation
2017
• Online catalogue of permitted ingredients
• Review and appeal rights for ingredient applicants
2018
• Permitted indications for listed medicines
• Assessed listed pre-market evaluation pathway
• 2 year market exclusivity for new ingredients
• Legislated evaluation timeframes
2019
• ‘TGA assessed’ claim
• Risk-based approach to listed medicine variations
Regulatory updates from the Complementary and OTC Medicines Branch

4. Overview of complementary medicines regulatory framework
Australian Register of Therapeutic Goods (ARTG)
AUST L
Listed medicines
NO premarket evaluation
BUT must have:
• GMP
• Permitted ingredients
• Permitted indications
Lower risk
AUST L(A)
Assessed Listed medicines
Premarket evaluation for
efficacy only
(Intermediate level & permitted
indications)
BUT must have
• GMP
• Permitted ingredients
AND can have
• TGA assessed claim
AUST R
Registered medicines
Premarket evaluation for:
• GMP
• Quality
• Safety
• Efficacy
AND can have
• TGA assessed claim
Higher risk
Regulatory updates from the Complementary and OTC Medicines Branch

5. Permitted indications:
Reality of implementation
Regulatory updates from the Complementary and OTC Medicines Branch 4

6. What do permitted indications mean for sponsors?
• Sponsors listing a medicine on the ARTG are only able to use
indications from a list of permitted indications
• “Free text” field is no longer available
• Sponsors must continue to hold supporting evidence for their
medicine indications
• There must not be inconsistency between the indications that
are listed in the Register and on the label
• 3 year transition period for existing listed medicines
Regulatory updates from the Complementary and OTC Medicines Branch
5

7. Transition arrangements – key dates
• All new listed medicines must select permitted
indications
• Sponsors of medicines listed in the ARTG before
6 March 2018 must re-list their medicine using
‘permitted indications’ by 6 March 2021
• Products that have not transitioned by 6 March
2021 will be cancelled from the ARTG.
Changes made before 6 September 2019 can be done free of charge
Regulatory updates from the Complementary and OTC Medicines Branch

8. Permitted indications
Benefits
• Greater transparency for sponsors on what
indications are suitable for listed medicines
• Avoids consumers being misled by inappropriate
indications
• Reduces the rate of inadvertent sponsors non-
compliance
• Sets a clear boundary between the standard
listing and the assessed listed and registration
pathways
Regulatory updates from the Complementary and OTC Medicines Branch

9. Challenges
?
Consumers
TGAIndustry
The list is too long! ‘The TGA is endorsing
pseudo science!!!’
A comprehensive list of
indications suitable for
listed medicines
The list is too short!
• Restricted
representations
• Biomarkers etc..
Regulatory updates from the Complementary and OTC Medicines Branch

10. Transition summary
10319 listed
medicines in the
ARTG
– 4629 using
permitted
indications
(~45%)
– 5693 with
‘standard’ or
specific
indications
Permitted indications commenced 6 March 2018
Regulatory updates from the Complementary and OTC Medicines Branch

11. Nothing is perfect …
Updates to the list of permitted indications since implementation
• New indications
• Clarity and consistency in
requirements
• New requirements
• Correct errors/omissions
Feedback welcome!
Regulatory updates from the Complementary and OTC Medicines Branch 10

12. Questions from industry
Additional guidance/clarification
• When do I need to use evidence qualifiers?
• What evidence do I need if my indications aren’t
qualified?
• How can I combine indications on my medicine
labels?
• How can pregnancy indications be used?
See FAQs on issues raised by industry in relation to permitted indications
Regulatory updates from the Complementary and OTC Medicines Branch
11

13. Questions from industry
Use in advertising
• Am I compliant with the advertising code?
Application requirements for new indications
• What evidence is required for applications for
new indications?
Re-listing process
• How do I do it?
• ELF is……slow
Regulatory updates from the Complementary and OTC Medicines Branch
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14. Our advice …
• Follow the Permitted indications for listed
medicines guidance
– Keep it simple when modifying or combining
indications
– Use the indication qualifiers from the drop down
lists in ELF
• Start preparing to transition early - you may need
to make other changes (e.g. update GMP)
Regulatory updates from the Complementary and OTC Medicines Branch
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15. Assessed listed
medicines pathway:
Reality of implementation
Regulatory updates from the Complementary and OTC Medicines Branch
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16. Assessed listed medicine pathway
• Sponsors self-assess the safety (permitted
ingredients) and quality (pre-approved GMP)
of their medicine
• TGA pre-market assessment of scientific
evidence supporting efficacy for the
proposed indications
• Allow higher-level claims which are not
included on the permitted indications list
(eg restricted representations)
Regulatory updates from the Complementary and OTC Medicines Branch

17. Assessed listed medicine pathway
Benefits
• Access to higher level indications than those on
the list of permitted indications
• Encourages industry to improve the standard of
evidence for listed medicines
• Bridges the gap between the existing listed and
registered medicines pathways
Marketing advantage through use of the ‘TGA
assessed’ claim
Regulatory updates from the Complementary and OTC Medicines Branch

18. Challenges
Flexibility for
industry
Suitable
indications
Evidence
standards
Consumer confidence
Regulatory updates from the Complementary and OTC Medicines Branch

19. Feedback from pre-submission meetings
Common discussion points
• Low vs intermediate vs high level indications
• Suitability of suggested indication vs clinical
trial design/evidence:
⁻ e.g. dosing on proposed label vs clinical trial
⁻ e.g. proposed formulation vs clinical trial
formula - what can be changed?
• Dossier requirements
Regulatory updates from the Complementary and OTC Medicines Branch
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20. Our advice …
• Request a pre-submission meeting
• Identify appropriate indications
• Take care when putting your dossier
together – there are mandatory
requirements
Regulatory updates from the Complementary and OTC Medicines Branch
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21. ‘TGA assessed’ claim
Regulatory updates from the Complementary and OTC Medicines Branch
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22. TGA assessed claim
• Sponsors of assessed listed medicines and
registered complementary medicines have
the option to use ‘TGA assessed’ claim’
• Indicates that the efficacy of the product
has been assessed for the approved
indications by the TGA
• The medicine label is required to be
approved by the TGA before marketing
• There is an approved symbol and approved
label statement
Regulatory updates from the Complementary and OTC Medicines Branch
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23. TGA assessed claim
Benefits
• Support consumers to make informed
purchasing decisions
• Improve consumer awareness about
medicines regulation
• Incentive for product sponsors to improve
the standards of evidence for
complementary medicines
Regulatory updates from the Complementary and OTC Medicines Branch

24. TGA assessed claim – consumer insights
Design considerations
• Use simple language (e.g. avoid ‘efficacy’)
• Refer to the Government to build trust
• A symbol is more recognisable than a statement
Regulatory updates from the Complementary and OTC Medicines Branch

25. TGA assessed claim – consumer insights
Unsure about
• Who the TGA is
• How we regulate
• What we have assessed
BUT
• Likely to be a positive influence on purchasing decisions
Regulatory updates from the Complementary and OTC Medicines Branch

26. Access to the TGA assessed claim
• Contact the TGA for the symbol file at
complementary.medicines@health.gov.au.
• Guidance on the process and requirements
now available:
– Location
– Text size
– Font style and colour
– Use in advertising
Regulatory updates from the Complementary and OTC Medicines Branch
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27. Coming soon….
• Changes to the Advertising Code to
allow use for registered
complementary medicines
• Instrument of approval
Regulatory updates from the Complementary and OTC Medicines Branch

28. Coming soon…
• Support understanding of the TGA
assessed claim and the TGA:
– Education for pharmacists and
pharmacy assistants
– Simpler resources for use by
consumers
– Improve the usability and information
provided on the TGA website for
consumers
Regulatory updates from the Complementary and OTC Medicines Branch

29. Market exclusivity for new ingredients:
Reality of implementation
Regulatory updates from the Complementary and OTC Medicines Branch
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30. Market exclusivity for new ingredients
• A successful applicant for a new permitted ingredient
may have exclusive use of that ingredient for a 2 year
period
• Use of a protected ingredient in a listed medicine is
restricted to:
 the ingredient applicant
 other persons nominated by the applicant
• At the end of the exclusivity period, any sponsor can include the
ingredient in their listed medicine included in the ARTG
Regulatory updates from the Complementary and OTC Medicines Branch

31. Eligibility for market exclusivity
Eligible
New ingredients not currently
included in the Permissible
Ingredients Determination, provided:
– not used in, or available for use
in registered medicines
Active or excipient ingredients
Ineligible
New role or a change to any existing
requirements for use eg:
 from excipient to an active
ingredient
 level of use (e.g. from 0.5% to 1%)
 route of administration (e.g. topical
use to oral use)
 different plant part or preparation
Regulatory updates from the Complementary and OTC Medicines Branch

32. Questions from industry
• How can I find out if an ingredient is
already under evaluation?
• Will TGA do anything to stop unauthorised
use of ingredients during the exclusivity
period?
• How do I nominate a sponsor to use my
protected ingredient?
Regulatory updates from the Complementary and OTC Medicines Branch
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33. Our advice…..
• ‘Opt-in’ at the time of making the
application
• Confirm the identity of your
ingredient
Regulatory updates from the Complementary and OTC Medicines Branch
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34. Reforms on the way 2019- 2020
the way in 2019 - 2020
• Guidance on use of
comparable overseas regulator
reports
• Efficacy monographs for listed
medicines
Regulatory updates from the Complementary and OTC Medicines Branch
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35. Use of comparable overseas regulators
• Where possible, the TGA makes use of
assessment from other regulators for evaluation
of new substances and products.
• We are developing:
⁻ a list of countries and jurisdictions from whom
TGA will accept reports
⁻ transparent criteria for and guidance for
identifying CORs
⁻ a process for using overseas reports
Regulatory updates from the Complementary and OTC Medicines Branch
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36. Use of comparable overseas regulators
Benefits for industry
• Faster market access for new
products and ingredients
• Decreased workload through
reduced set of RFI
• Predictability through reduced
approval timeframes
• Greater transparency around
likely acceptance of reports
Benefits for TGA
• Improved efficiency
• Best of both worlds – sovereign
decisions and potential for greater
international harmonisation
Regulatory updates from the Complementary and OTC Medicines Branch

37. Pathways if a report is available
COR-based process
• Evaluation based solely
on the use of COR reports
Combined with
• TGA assessment of
Australian aspects on, eg
the product label
Mixed evaluation
• Evaluation of safety,
quality, and/or efficacy
based on the use of COR
reports
Combined with
• Evaluation of the missing
parameters
Full evaluation by TGA
• Full independent
evaluation of all
parameters: quality,
safety, and/or efficacy.
Can include reports from
overseas agencies not
on the COR list
Increasing evaluation timeframes
Regulatory updates from the Complementary and OTC Medicines Branch
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38. Application categories for the COR report-based process
Category Description Screening Evaluation
IN1 Evaluation of safety and quality based on evaluation reports
from CORs 40 70
IN2 Evaluation of safety based on evaluation reports from CORs
Independent evaluation of quality by the TGA 40 120
IN3 Evaluation of quality based on evaluation reports from CORs;
or an accepted monograph.
Independent evaluation of safety by the TGA
40 150
IN4 Full evaluation of safety and quality by the TGA 40 180
Regulatory updates from the Complementary and OTC Medicines Branch

39. COR report-based process
• TGA publish list of CORs
Implementation
• Applicants use ‘Criteria for acceptance of COR
reports’ to identify suitable reports
Pre-submission
• Submit COR report and full dossier
• Confirmation that application is eligible for COR
report-based process
Submission
• TGA evaluation focusing on data generated for the
Australian context
Evaluation
Update from the Complementary and OTC Medicines Branch

40. Challenges
Submission through the
COR report-based process
is NOT a rubber stamp…
?
Regulatory
differences
Confidence
building
Types of
reports
Differences in
decisions or approvals
(e.g. for indications)
Regulation
internationally as
foods, medicines,
cosmetics of dietary
supplements
Understanding
regulatory
frameworks and
sharing evaluation
reports
Assessment of safety or
quality or efficacy?
Regulatory updates from the Complementary and OTC Medicines Branch

41. Questions from industry
• When will the COR list and guidance be
available?
• Can TGA get the COR reports for me?
• What if I have a report from a overseas agency
that is not on the list?
• What if the report I have doesn’t meet all of the
criteria for the COR report-based process?
Update from the Complementary and OTC Medicines Branch 40

42. Questions?