Reforms to the regulatory framework for listed medicines Dr Cheryl - - PowerPoint PPT Presentation

Reforms to the regulatory framework for listed medicines

Dr Cheryl McRae Assistant Secretary, Complementary and OTC Medicines Branch Medicines Regulation Division, TGA

Complementary Medicines Australia Innovation Seminar and Expo 2 May 2018

Listed medicines regulatory framework

Reforms Implemented already

• application timeframes & categories for ingredient

evaluations for listed medicines

• market exclusivity for new ingredients
• list of permitted indications for listed medicines
• ‘Assessed listed’ pre-market evaluation pathway

Reforms on the way

• Use of comparable overseas regulator reports
• Efficacy assessment ‘claimer’

Reforms to come

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Old (pre-reforms) Listed Medicines Regulatory Framework

Pre-approved ingredients

Good manufacturing practice (GMP) Pre- approved/self- selected indications

Medicine listed

• n the ARTG

Post-market compliance

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There are now three pathways for complementary medicines

Australian Register of Therapeutic Goods (ARTG) AUST L Listed medicines

No pre-market evaluation BUT

• Pre-approved GMP
• Pre-approved ingredients
• Permitted indications

Lower risk AUST L(A) Assessed Listed medicines

Pre-market evaluation for:

• Efficacy – Intermediate (&

permitted) level indications

• Optional ‘claimer’

BUT

• Pre-approved GMP
• Pre-approved ingredients

AUST R Registered medicines

Pre-market evaluation for:

• Quality
• Safety
• Efficacy
• Optional ‘claimer’ ???

Higher risk

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Listed medicines - Permitted ingredients

Pre-approved ingredients

AUST L AUST L(A)

Permitted indications AUST L GMP

• AUST L and AUST L(A) can only use permitted

in

gredients.

• All permitted ingredients and requirements contained

in the Permissible Ingredients Determination.

• Ingredients database online: www.ebs.tga.gov.au
• If an ingredient is not currently permitted for use in

listed medicines, sponsors can apply for the substance to be evaluated.

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Application categories and timeframes for ingredient applications

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

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Use of comparable overseas regulators

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• Where possible, the TGA makes use of assessment from other

Regulators for evaluation of a substance for use in listed c

• mplementary medicines.
• The TGA is continuing to address the Government’s policy of

accepting ‘trusted international standards and products’ through implementation of the MMDR reforms.

• 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

Criteria for comparable overseas regulators

• The regulator must be an internationally recognised regulatory authority with an

established track record of approving low risk food, chemical or medicinal substances.

• The regulator must have a transparent system for regulatory decision-making.
• The regulator should have a similar decision-making framework, risk assessment

methodologies and legal responsibilities (including confidentiality and impartiality) to the TGA.

• The regulator must use internationally accepted scientific standards and

guidelines.

• The TGA must have, or be able to establish, a relationship with the overseas

regulator.

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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.

• During the specified exclusivity period the 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, the exclusive approval will

revert to a general approval and any sponsor can include the ingredient in their listed medicine included in the ARTG.

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When market exclusivity applies

• Exclusivity will only be permitted for a new complementary

medicine ingredient (active or excipient) that is not currently included in the Permissible Ingredients Determination, provided that:  it has not previously been evaluated by the TGA for use in listed or

registered medicines  it is not used in, or available for use in registered medicines

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When market exclusivity will not apply

• Exclusivity will not apply to applications submitted for a new role or a change

to any existing requirements for use of a permitted ingredient, for example, applications for:

 A change of permitted use from excipient to an active ingredient  a change to the permitted level of use (for example, from 0.5% to 1%)  a change to the permitted route of administration (e.g. from topical use to oral use)  a change to the permitted use of a herbal ingredient (e.g., a different plant part or preparation

method)

 a change to the requirements to allow use of another strain of a species which is a permitted

ingredient (e.g. addition of the LA-5 strain to Lactobacillus acidophilus)

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Listed medicines –standard pathway (AUST L)

Permitted ingredients Permitted indications GMP

Permitted indications

• All permitted indications and their requirements are

contained in the Permissible Indications Determination. New listed (AUST L) medicines can only use permitted indications.

• 3 year transition period for sponsors of existing listed

medicines.

• Sponsors still required to hold evidence of efficacy
• Process and fee for adding new indications

11 NEW

Criteria for Permitted Indications

• Permitted indications only refer to:
• health enhancement e.g. ‘Promote healthy digestion’
• health maintenance e.g. ‘Maintain healthy joints’
• prevention of dietary deficiency e.g. ‘Prevent dietary calcium

deficiency’

• a non serious form of a disease or ailment etc. e.g.‘Relieve

symptoms of common cold’

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An exception to these criteria are sunscreen indications and specific indications linked to substance-based restricted representation approvals (folic acid, calcium and vitamin D).

Guidelines

• n website

Benefits of the list of permitted indications

• Greater transparency for consumers and sponsors and

what is appropriate for listed medicines.

• Avoid consumers from being misled by inappropriate

indications and increase consumer confidence in listed medicines.

• Reduce the rate of inadvertent sponsor non-compliance.
• The TGA now has the capacity to provide accurate

statistics on listed medicines e.g. traditional products.

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Summary – Using permitted indications

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• 1. Select tradition of use

(Optional) Indications that do not specify a tradition of use are by default scientific.

• 2. Select core permitted

indication (Mandatory) At least one core indication is selected in ELF using drop down lists

• r key word search.
• 3. Select specifying qualifiers

(Optional) Sponsors can choose to apply one or more pre- approved qualifiers from a drop down list.

Complementary Medicines Australia Innovation seminar May 2018

Target population Time of use Tradition of use N/A Core permitted indication ’Relieves muscle aches and pains Specifying qualifiers Healthy target population: ‘in healthy individuals’ Time of use: ‘after exercise’ Final permitted indication on the ARTG Relieves muscle aches and pains after exercise in healthy individuals.

Including indications on medicine label

• Indications do not have to be included ‘word for word’ on your

label or advertising material.

• However, the intent and meaning of the indication must not change
• i.e. the same therapeutic action and target

For example: – ARTG indication: ‘Maintain/support gastrointestinal health’ – Label indication - same meaning: ‘Maintains healthy gut’ – Label indication - different meaning: ‘Maintain healthy intestinal flora’

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Indications – Type of evidence

Traditional indications Include traditional terms that may be applicable across multiple traditional paradigms, e.g. ‘cholagogue’, ‘alterative’ ‘adaptogen’ and must be support by evidence of a tradition of us. Traditional Chinese Medicine indications Contain TCM specific terminology and must be supported by evidence of TCM use, e.g. ‘Increase Qi flow’ Traditional Ayuvedic Medicine indications Contain Ayuvedic specific terminology and must be support by specific evidence of Ayuvedic use, e.g. ‘Balance Vata Scientific indications Must be supported by scientific evidence only, e.g. ‘Helps maintain/support bone mass/density’

Traditional medicines must include a traditional use qualifier in the ARTG and on the product label

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Assessed Listed Medicine pathway

Permitted ingredients Intermediate level therapeutic indications GMP

• Sponsors self-assess the safety (permitted ingredients) and

quality (pre-approved GMP) of their medicine.

• TGA pre-market assessment of scientific evidence only

supporting efficacy of the indications in finished product.

• Allow higher-level claims (intermediate) which are not

included on the permitted indications list

• Can also include low level indications eg permitted

indications.

• Option to use an efficacy ‘claimer’.

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Benefits of assessed listed pathway

• Broadens the scope of the listing framework to allow

access to higher level indications than those on the list of permitted indications

• Encourages industry to improve the standard of evidence

regarding the efficacy of complementary medicines.

• Bridges the gap that exists for industry between the

existing listed and registered medicines pathways.

• Allows greater consumer access to a wider range of

evidence-based remedies to self-manage their health.

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Evidence for assessed listed medicines

• Only products supported by quality scientific evidence

for efficacy will be accepted for pre- market assessment through this pathway.

• Assessment of efficacy data will be based on the

finished product (rather than active ingredients in isolation) and include a detailed evaluation of evidence to support all intermediate and permitted indications.

• Guidelines on the evidence required to support

indications for assessed listed medicines are available

• n website.

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Label ‘claimer’

• The MMDR recommended that, where a medicine is

listed in the ARTG under the assessed listed medicines pathway, the sponsor should be able to indicate on all promotional materials and on the medicine label, that the efficacy of the product has been independently assessed for the approved indications by the TGA.

• The Government accepted this recommendation in

principle, noting that the design and use of promotional statements will require careful consideration by the TGA and further consultation with stakeholders

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Public consultation on a “claimer”

• We will seek feedback on the following:

– the class or classes of medicines that should be allowed to carry an optional claimer – options to implement the claimer as a visual identifier and/or label statement – how the claimer can be used on medicine labels.

• We will also conduct consumer focus group testing on the
• ptions presented in the public consultation

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Benefits of claimers

• Allow products that have had their efficacy

assessed to differentiate themselves in the market - marketing advantage.

• Incentive to increase the evidence base for

complementary medicines.

• Increase transparency for consumers in relation to

the level of assessment for the different ARTG application pathways.

• Help consumers make more informed healthcare

decisions when self-selecting medicines.

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Reforms : Next steps

• Public consultation on a claimer

Enhanced post-market monitoring scheme for listed medicines (Rec 4

 Greater targeting of sponsors with a significant history of non-compliance  Enforcing sanctions and penalties for repeat non-compliance  Increase transparency for consumers through publication of review outcomes  Improved guidance for sponsors about their regulatory obligations

• Revised guidance material
• ARGCM
• Guidance on use of comparable overseas regulator reports

Development of efficacy monographs for commonly used active ingredients – link with permitted indications.

9)

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Find out more:

www.tga.gov.au/mmdr

MMDR.consultation@health.gov.au

Questions?

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