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Presentation: Spotlight on complementary medicines MMDR reforms
TGA presentation given at 2017 ARCS Annual Conference, 22-24 August 2017
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.
- Presented by: Michael Shum, Director, Complementary Medicines Reforms, Complementary and OTC Medicines Branch, Medicines Regulation Division, TGA
- Presented at: 2017 ARCS Annual Conference
- Presentation date: 22 August 2017
- Presentation summary: An overview of reform initiatives relevant to complementary medicines arising from the Review of Medicines and Medical Devices Regulation.
Spotlight on complementary medicines MMDR reforms
Director, Complementary Medicines Reforms
Complementary and OTC Medicines Branch,
Medicines Regulation Division, TGA
2017 ARCS Annual Conference, August 2017
Slide 1 - Review of Medicines and Medical Devices Regulation (MMDR)
- July 2015: the Expert Panel released their recommendations arising from the review
- 19 recommendations to improve the regulation of complementary medicines
- September 2016: Government response released
- accepted the majority of the review's recommendations in full or in-principle
- identified the need for consultation with stakeholders in progressing the reforms
Slide 2 - 5 streams of work
- Stream 1
- Enhancing the listing framework
- Stream 2
- Improving transparency for consumers
- Stream 3
- Increased flexibility for sponsors and improving the evidence base
- Stream 4
- Increased flexibility and predictability for industry
- Stream 5
- Enhanced post-market monitoring and compliance actions
Slide 3 - Stream 1: Enhancing the listing framework
Recommendation Government Response Recommendation 34: Capacity to refuse to list Supports the intent of the recommendation Recommendation 37: Online searchable catalogue of permissible ingredients Accepts the recommendation Recommendation 38: Establishing a list of permitted indications Accepts the recommendation
Slide 4 - Recommendation 38: Permitted indications
The Panel recommends that the TGA establishes the list of permitted indications, from which sponsors must exclusively draw, for listed medicinal products in the ARTG.
The Commonwealth accepts Recommendation 38, noting that implementation of the list of Permitted Indications will require legislative change and will be subject to consultation with consumers, sponsors and health professionals.
Slide 5 - What does Permitted Indications mean for sponsors?
- Sponsors listing a medicine on the ARTG will only be able to use indications from a permitted indications list
- The "free text" field will no longer be available
- TGA will also have the ability to create a non-permitted indications list e.g. smoking cessation
- 3 year transition period proposed
Slide 6 - Permitted indications on product labels
Indications will not have to be 'word for word' on the label or advertising material:
- the intent and meaning of the indication must not change
- this will give flexibility to sponsors and contain the size of the list
ARTG indication: 'Maintain/support bowel regularity'
Label indication - same meaning: 'X helps maintain regular bowel movements'
Label indication - different meaning: 'X relieves constipation'
Slide 7 - Development of the permitted indications list
- A draft list of permitted indications has been published on the TGA website
- Stakeholders have the opportunity to review, comment and propose new indications
- Supporting materials have been published to help stakeholders understand how regulatory requirements for listed medicines will change
- The list is open for comments and suggestions until 31 October 2017
- New indications proposed after this time will incur a fee
Slide 8 - Criteria for permitted indications
- Must only refer to:
- health enhancement
- health maintenance
- prevention or alleviation of dietary deficiency; and/or
- a health benefit for a non-serious forms of a disease, ailment, defect or injury
- Permitted indications can only refer to conditions that are:
- A delay in medical treatment would not be detrimental to the consumer
Slide 9 - Table
Low Level Indications What this means Examples Health enhancement
Beneficial effects of substances on the physiological and /or psychological state of the body;
- above and beyond normal growth, development and functions of the body
Helps improve immune system
May increase energy / reduce fatigue
Helps stimulate digestive function
Health maintenance Normal physiological effects of substances in; growth, development and normal functions of the body
Helps maintain healthy hair, skin and nails
Assists with normal liver function
Helps support healthy connective tissue / joints
Prevention or alleviation of a dietary deficiency Prevention of mild dietary deficiency (not prevention of diseases resulting from severe deficiency)
When taken regularly, may prevent vitamin D/ calcium deficiency
Helps reduce the risk of iodine deficiency
Helps prevent dietary vitamin B12 deficiency
Slide 10 - Table
Low Level Indications What this means Examples
A non-serious disease, ailment, defect or injury
(other than prevention or alleviation)
Those low risk conditions that are non-serious and self manageable.
May be related to:
- reduction in risk/frequency/duration
- management or improvement in quality of life
... without resolution of the underlying non-serious disease, ailment, defect, condition or injury.
May relieve symptoms of mild osteoarthritis
Helps reduce the severity of common cold symptoms
For the management mild dermatitis symptoms
May relieve post-menopausal/PMS symptoms
Helps reduce the frequency of common cold sore outbreaks
Slide 11 - Implementation: Proposed approach
- Sponsors will be required to certify that indications for their medicine are from the permitted indications list and they hold supporting evidence
- Consistent with current Evidence Guidelines, qualifying terms can be used by sponsors to align indications with the evidence they hold
- Indications will have a consistent structure and terminology to describe therapeutic uses appropriate for listed medicines
- Sponsors will select 'core permitted indications' (action and target only) with optional qualifiers
Slide 12 - Selecting permitted indications when listing a medicine
- Select tradition of use (Optional) - Indications that do not specify a tradition of use are by default scientific
- Tradition of use - N/A
- Select core permitted indication (Mandatory) - At least one core indication is selected in ELF using drop down lists or key word search
- Core permitted indication - Relieves muscle aches and pains
- Select specifying qualifiers (Optional) - Sponsors can choose to apply one or more pre-approved qualifiers to each core permitted indication by selecting from a drop down list
- Healthy target population
- Time of use
Healthy target population: 'in healthy individuals'
Time of use: 'after exercise'
Final permitted indication on product label
E.g. Temporarily relieve muscle aches and pains after exercise in healthy individuals
Slide 13 - Transition arrangements
- From 1 January 2018, all new listed medicines must select permitted indications (free text will be turned-off)
- Sponsors of existing listed medicines will be required to transition their existing indications to 'permitted indications' by 31 December 2020:
- AUST L numbers will not change
- Fee waiver/reduction if indications changed by 31 June 2019
- Listed medicines that do not transition to permitted indications will be cancelled from the ARTG from 1 January 2021
Slide 14 - Stream 2: Improving transparency for consumers
Recommendation Government Response Recommendation 43: Requirement to publish efficacy evidence Supports the intent of the recommendation Recommendation 44: Publication of disclaimers on promotional material where product has not had efficacy assessed Supports the intent of the recommendation and will conduct further consultation on ways to better educate consumers however the Government will not require sponsors to place a disclaimer on product labels Recommendation 45: Publication of a 'claimer' where product has had efficacy assessed by TGA Accept in principle Recommendation 46: Adopt or develop evidence monographs Accepts the recommendation
Slice 15 - Recommendation 45: Claimers for assessment of efficacy
Where a medicinal product is listed in the ARTG following an assessment by the TGA of an application under Option Two (refer to Recommendation 39), the sponsor is able to indicate on all promotional materials and on the product label, that the efficacy of the product has been independently assessed for the approved indications.
Accepts-in-principle Recommendation 45, noting that the design and use of the promotional statements will require careful consideration by the TGA and further consultation with stakeholders.
Slide 16 - Label 'claimer': Key features
- A claimer can be used by medicines that have had TGA pre-market assessment:
- medicines assessed via the assessed listed medicines pathway (refer to Recommendation 39)
- Registered complementary medicines
- A claimer cannot be used by medicines that have not had a pre-market assessment:
- Listed medicines, including those that have been subject to a post market compliance review
- "Grandfathered" medicines
Slide 17 - Label 'claimer': Key features
- Must be supported by the appropriate scientific evidence for all indications made for the medicine
- Must not imply superiority of the product over other medicines that have been pre-market assessed (e.g. prescription medicines)
- Must not be more prominent or detract from the label information mandatorily required by the current Labelling Order
Slide 18 - Claimer: Next steps
- Consumer testing
- visual claimers
- wording options
- E.g. 'Efficacy assessed by the TGA'
- Targeted consultation
- Education campaign
Slide 19 - Stream 3: Increased flexibility for sponsors and improving the evidence base
Recommendation Government Response Recommendations 35/36: Continue to evaluate ingredients on safety, evidence and quality with two new methods for assessment of ingredients Accepts both recommendations Recommendation 39: Three pathways for inclusion of Listed medicines on the ARTG Accepts the recommendation Recommendation 40: Develop two new pathways for Registered complementary medicines Accepts the recommendation
Slide 20 - Recommendation 39: Three assessment pathways for complementary medicines
The Panel recommends 3 options by which sponsors may seek ARTG entry for complementary medicines:
- Option 1: Listing in the ARTG following self-declaration by the sponsor regarding safety, quality and efficacy (current Listing pathway)
- Option 2: Listing in the ARTG following self-assessment of the safety and quality but a TGA assessment for efficacy (New pathway)
- Option 3: Registration in the ARTG following full TGA assessment of safety, quality and efficacy (current Registered pathway)
Slide 21 - Recommendation 39: Three assessment pathways for complementary medicines
The Commonwealth accepts the recommendation, noting that legislative amendments are required to implement Option Two.
Implementing this recommendation would increase transparency for consumers, provide additional flexibility for sponsors and support innovation.
Slide 22 - Assessed listed medicines pathway: Key features
- A new assessment pathway sitting between the existing listed medicine (low risk) and registered medicine (high risk) pathways
- Maintains low risk status based on their ingredients, the way they are presented and the potential harm associated with their use
- Can use 'intermediate claims' which are not included on the permitted indications list:
- Low level indication: 'May help relieve muscle aches and pains'
- Intermediate level indication: 'May help relieve arthritis'
Slide 23 - Assessed listed medicines pathway: Key features
- Still required to comply with GMP requirements
- Claims must be supported by appropriate scientific evidence
- TGA evaluates the evidence for efficacy before it is listed
- Option to include a claimer on all promotional material stating it has been independently assessed
Slide 24 - Proposed approach: Assessment pathways
Listed Medicines New Pathway Registered Medicines Permitted ingredients Permitted ingredients Not limited to selecting from permitted ingredients list Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Low level permitted indications only At least one 'intermediate indication' May have higher level indications No pre-market assessment Pre-market assessment of evidence for efficacy Full pre-market assessment Ability to claim that efficacy has been assessed
Slide 25 - Proposed approach: Indications
Listed medicines New pathway Registered medicines
Low level indications
May refer to:
- health enhancement
- health maintenance
- prevention/alleviation of dietary deficiency
- a health benefit for a non-serious disease or condition (symptomatic relief)
E.g: maintain/support healthy bones
Intermediate level indications
May refer to:
- a health benefit for a serious disease (i.e. restricted representations)
- prevention, alleviation or management of a non-serious disease or condition (of a higher risk to consumers than low level indications)
E.g: prevention of osteoporosis
High level indications:
May refer to the:
- cure or
Of a serious form of a disease, ailment, defect or injury (restricted reps)
Must not refer to a prohibited representation
Slide 26 - Establishing efficacy
- Sponsors will be required to meet minimum evidence requirements
- Existing approaches to establish efficacy for listed and registered complementary medicines will be retained
- For the new pathway:
- There will be flexibility in how the evidence requirements can be met (de novo vs. well established ingredients)
- Sponsor will self-assess the safety and quality
- (permitted ingredients, compliance with quality standards and GMP)
Slide 27 - Next steps
- TGA will conduct a pilot of the new pathway prior to implementation in 2019
- Expressions of interest via the TGA website late 2017
- Minimum data requirements for product efficacy will be developed standardise pre-market assessments
- Further consultation to develop evidence guidelines
Stream 4: Increased flexibility and predictability for industry
Recommendation Government Response Recommendation 41: Develop legislative timeframes for pre-market assessments Accepts the recommendation Recommendation 42: Management of variations Accepts the recommendation Recommendation 47: Expand review and appeal rights Supports the intent of the recommendation Recommendation 50: Incentives for innovation of complementary medicines Accepts in principle
Slide 29 - Recommendation 50: Incentives for innovation
The Panel recommends that the Australian Government gives consideration to improving the competitiveness of the Australian complementary medicines industry by providing incentives for innovation
The Commonwealth accepts-in-principle Recommendation 50, noting the cross government responsibility for innovation policy
Slide 30 - Incentives for new ingredients: Key features
- The current process for new ingredient applications does not protect the resources invested by applicants
- Proposal to allow for a 2 year market exclusivity period for new complementary medicine ingredients approved for use in listed medicines.
- Implementation will:
- Encourage research into emerging areas of complementary medicines.
- Provide incentive for industry to innovate and bring new products to market.
Slide 31 - Stream 5: Enhanced post-market monitoring and compliance actions
Recommendation Government Response Recommendation 49: Enhanced post market monitoring scheme Accepts the recommendation, noting that the intent of some elements of the recommendation can be achieved within existing mechanisms
Slide 32 - Recommendation 49: Enhanced post-market compliance
The Panel recommends a more comprehensive post-market monitoring scheme for listed medicinal products, including complementary medicinal products. Such a scheme should include:
- an increase in the number of products subject to random/targeted reviews integration of available datasets, including eHealth and hospital
- records, to provide a more streamlined and cost effective approach to post-market monitoring
- provision for electronic reporting of adverse events
- enhanced collaboration with overseas regulators to share information relating to safety or efficacy of comparable products.
Slide 33 - Recommendation 49: Enhanced post-market compliance
The Commonwealth accepts Recommendation 49, as the development of a more comprehensive post-market monitoring scheme will enhance consumer protection and complement existing post-market monitoring processes. The Commonwealth notes that the intent of some elements of the recommendation can be achieved within existing mechanisms.
Slide 34 - Enhanced post-market compliance: Key features
How are we going to do this?
- Greater targeting of sponsors with a significant history of non-compliance
- Enforcing sanctions and penalties for repeat non-compliance
- Improved guidance for sponsors about their regulatory obligations
- Provide more information on the TGA website to encourage higher levels of compliance
Slide 35 - Phased implementation 2017 - 2019
- Online searchable catalogue of permitted ingredients
- Review and appeal rights for ingredient assessment
- Permitted Indications
- New assessment pathways for registered complementary medicines and new ingredients
- Risk-based approach to medicine variations
- The New Pathway
- Label claimer
Slide 36 - MMDR consultations
- Targeted stakeholder consultations commenced October 2016.
- Public consultations throughout 2017.
- The proposed reforms arising from recommendations 38, 39, 45 and 50 are addressed in our first public consultation paper.
- Outcomes from this consultation are on the TGA website.
Slide 37 - MMDR consultation - Business process improvements
Second public consultation due for release September 2017
- Broadening the range of sources of evidence for new ingredient assessment (Recommendation 35)
- Use of evaluation reports from comparable overseas regulators (Recommendations 36 & 40)
- Introduction of legislated timeframes for ingredient assessment (Recommendation 41)
- Enhancing post-market compliance (Recommendation 49)
See the MMDR public consultation forecast on the TGA website for further information
Slide 38 - Next steps
- Legislative amendments to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990
- Further consultation
- Transitional arrangements
- Sponsor education
- Updated guidelines
Slide 39 - Questions?
Slide 40 - Find out more:
Website: Complementary medicines reforms
- July 2015: the Expert Panel released their recommendations arising from the review
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