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
Objectives of the listed medicines regulatory reforms
Industry
Simplify the listing system
Improve flexibility and predictability
Incentivise innovation
Consumers
Improve compliance
Improve the evidence base
Transparency about evidence
Regulatory updates from the Complementary and OTC Medicines Branch
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
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
Permitted indications: Reality of implementation
Regulatory updates from the Complementary and OTC Medicines Branch 4
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
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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
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
Challenges
Consumers
?
TGA Industry
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
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
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!
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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
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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
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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)
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Assessed listed medicines pathway: Reality of implementation
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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
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
Challenges
Flexibility for industry
Suitable indications
Evidence standards
Consumer confidence
Regulatory updates from the Complementary and OTC Medicines Branch
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
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Our advice … • Request a pre-submission meeting
• Identify appropriate indications
• Take care when putting your dossier
together – there are mandatory
requirements
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‘TGA assessed’ claim
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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
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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
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
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
Access to the TGA assessed claim • Contact the TGA for the symbol file at
[email protected]. • Guidance on the process and requirements
now available: – Location – Text size – Font style and colour – Use in advertising
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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
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
Market exclusivity for new ingredients: Reality of implementation
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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
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
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?
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Our advice…..
• ‘Opt-in’ at the time of making the application
• Confirm the identity of your ingredient
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Reforms on the way 2019- 2020 the way in 2019 - 2020
• Guidance on use of comparable overseas regulator reports
• Efficacy monographs for listed medicines
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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
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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
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
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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
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
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
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
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Questions?
