Regulatory updates from the Complementary and OTC Medicines Branch - - PowerPoint PPT Presentation

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

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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

Regulatory updates from the Complementary and OTC Medicines Branch

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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)

• f 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

complementary.medicines@health.gov.au.

• 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

• f 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
• n 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

• verseas agencies not
• n 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;

• r 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?

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Questions?