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TGA presentation: ASMI Annual Conference, 27 October 2016

Presentation: Regulatory Reform - an update

14 November 2016


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: John Skerritt, Deputy Secretary for Health Products Regulation, Commonwealth Department of Health
  • Presented at: ASMI Annual Conference
  • Presentation date: 27 October 2016
  • Presentation summary: An update on TGA performance statistics, medicine labelling changes and the Review of Medicines and Medical Devices Regulation


Regulatory Reform - an update

John Skerritt
Deputy Secretary for Health Products Regulation
Commonwealth Department of Health

ASMI Annual Conference, 27 October 2016

Slide 1 - This presentation

  • New Health Products Regulation Group
  • Business as usual - performance statistics for 2015/16
  • TGA stakeholder survey
  • Medicine labelling changes
  • Medicines and Medical Devices Regulation Review
  • Next steps

Slide 2 - Health Products Regulation Group structure

Health Products Regulation Group Structure chart

Department of Health Secretary

Principal Medical Adviser and Principal Legal and Policy Adviser

Health Products Regulation Group - Deputy Secretary

  • Medicines Regulation
    • Prescription Medicines Authorisation
    • Complementary and OTC Medicines
    • Pharmacovigilance and Special Access
    • Scientific Evaluation
  • Medical Devices and Compliance
    • Medical Devices
    • Laboratories
    • Manufacturing Quality
  • Regulatory Practice and Support
    • Regulatory Services and Improvement
    • Regulatory Practice, Education and Compliance
    • Regulatory Engagement and Planning
  • Office of Drug Control
    • Medicinal Cannabis
    • Drug Control
  • Regulatory Reforms

Slide 3 - Complementary medicine business reforms

  • Electronic applications system for registered complementary medicines
  • Five registered complementary medicine categories based on availability of quality, safety and efficacy data
  • Single legislative source of information for about 5000 permitted ingredients
  • Updated evidence guidelines for listed complementary medicines
  • Strong international cooperation on CM ingredient safety (Sin/Can/Switz)
    • Common assessment template and approach to ADI calculations and minimum data requirements
    • Move to a common evaluation process, but individual regulators will make sovereign decisions to approve or reject applications

Slide 4 - 2015-16 TGA Performance statistics: complementary medicines

2014-15 2015-16
New listed medicines 1879 1644
New listed medicine ingredients approved 5 18
New registered medicines approved 4 2
Registered medicines variations approved 28 27

Slide 5 - Compliance problems: complementary medicines

  • The number of compliance reviews more than doubled, based on:
    • complaints and referrals from internal and external stakeholders
    • screening of recently-listed medicines
    • assessment of some products that are not listed on the ARTG
  • 80% of medicines had compliance breaches in 2015-16 (vs 73% for 2014-15)
    • Labelling, advertising and evidence are still the major compliance breaches
    • 3 products were found to have ingredient safety related issues in 2015-16
  • Information of each product is that cancelled published at Complementary medicines: Cancellations from the ARTG

Slide 6 - Outcomes of completed reviews

Pie chart of outcomes of completed reviews: Random reviews: - ARTG info (9%) - quality (9%) - labelling/advertising (40%) - evidence (41%) - safety (0%) - other (1%). targeted reviews: - ARTG info (11%) - quality (15%) - labelling/advertising (36%) - evidence (31%) - safety (6%) - other (1%)

Slide 7 - Actions taken following listed medicine reviews

Actions following a Request for Information
Medicines found to be compliant 81
Proposal to cancel notice sent by TGA 327
Total 408
 Actions following a Proposal to Cancel notice (327 medicines total)
Medicines cancelled by TGA 44
Medicines cancelled by sponsors 76
Compliance breaches were addressed 207

Slide 8 - OTC medicine approvals 2015-16 vs 2014-15

  • The number of new OTC applications was lower due to fewer low risk (N1) applications
  • Approval times for most application types consistent
  • Significant increase in approval times for N3 (‘generic’ medicine) and C4 (non-quality change) applications, due to application complexity
Application type Number completed Median Target time (days) % within target
New medicines
N1 79 14 45 100
N2 3 26 55 100
N3 25 90 150 100
N4 50 89 170 100
N5 6 151 210 83
Change applications
C1 618 5 20 97
C2 309 8 64 99
C3 4 31 120 100
C4 12 110 170 100

Slide 9 - Medicines labels – why change?

  • Label requirements had not been updated for over 15 years and are not aligned with international practices
  • Current labelling can lead to poor medicines use/safety concerns:
    • Lack of awareness of the active ingredients, possibility of accidental overdose when taking multiple medicines as well as dispensing errors
    • Poor readability of medicine labels
    • Difficulties in following directions for use or identifying advisory statements
    • Potential for use of the wrong medicine - similarities in medicine branding
  • Four year transition period from 31 Aug 2016, minimising cost to industry, aligning with ingredient name changes and rolling out education programs

Slide 10 - Main changes for OTC medicines include:

  • Larger text size for names and quantities of active ingredients in registered medicines
  • A minimum text size of 3.0 mm (smaller font sizes for medicines with >4 active ingredients, medium (25-60 mL) and small (<25 mL) containers
  • The name of the medicine must be in a continuous uninterrupted manner
  • Information required to be on a label must be in colours that contrast strongly with the background (batch number and expiry date can be embossed)

Slide 11 - Main changes for OTC medicines include:

  • The number of substances such as allergens that must be declared has increased (e.g. to include crustacea, fish, egg, soya, milk, tree nuts)
  • Most registered OTC medicines will require a table on their packaging that provides critical health information in a consistent manner
  • permit the use of an active moiety only when the full approved name is included in the ‘critical health information’ table
  • Sponsors can use either the ‘old’ or ‘new’ rules until 31 Aug 2020

Slide 12 - TGA stakeholder survey 2016

  • A requirement for the Government’s Regulator Performance Framework
  • 2810 responses: 449 health professionals, 65 consumers, 1628 from industry
  • Results remarkably positive in terms of trust and confidence in the regulator
    • 79% of industry have high/very high confidence in TGA safeguards
    • 61% of community/ consumer groups with 27 % ambivalent/ unsure
  • Users satisfied or very satisfied with TGA consultations (63%), exhibitions (75%) and information sessions (82%) respectively.
  • Main area for work is to TGA to engage more actively with consumers
    • They are aware of, and have a generally favourable perception of the TGA, but many unsure
    • Consumers also felt least engaged in TGA policy consultations

Slide 13 - TGA stakeholder survey 2016

Bar graph showig results of survey questions: 'Australia gets the balance right between the risks associated with therapeuitc goods and their benefit:' -Nett disagree 15% -Neither agree nor disagree 13% -Nett agree 68% -NA/not sure 4%. 'The TGA manages risks propotionately:' -Nett disagree 15% -Neither agree nor disagree 14% -Nett agree 66% -NA/not sure 5%. 'I trust the TGA to perform its rols ethically and with integrity:' -Nett disagree 6% -Neither agree nor disagree 8% -Nett agree 84% -NA/not sure 1%. 'The TGA is well regarded internationally:' -Nett disagree 5% -Neither agree nor disagree 13% -Nett agree 73% -NA/not sure 9%

Slide 14 - TGA stakeholder survey 2016

Bar graph with answers to the survey  question 'how satisfied are you with the TGA infomation website?:' - Net dissatisfied: 7% - Neither satisfied or dissatisfied: 24% - Nett satisfied: 69%

Bar graph showing answers to the question: 'Overall, how satisfied are you with the experince of communicating with the TGA?:' - Net dissatisfied: 15% -Neither satisfied or dissatisfied: 22% - Nett satisfied: 63%

Slide 15 - Review of Medicines & Medical Devices Regulation

  • Expert Panel commenced late 2014 after most of 2014 in pre-work
  • Review process included discussion papers, submissions and interviews by the panel
  • Two reports on medicines and devices and complementary medicines and advertising released during 2015 with 58 recommendations
  • Following release of the reports, workshops held with key stakeholders by the Department to get feedback on recommendations
  • Minister Ley took preferred position to Cabinet
  • Government response was publicly released on 15 September 2016

Slide 16 - Key principles endorsed by Government

  • The Australian Government retain responsibility for approval of therapeutic goods rather than automatically accepting international approvals, but TGA needs to:
    • make greater use of overseas evaluations
    • introduce greater flexibility in approval pathways for both medicines and medical devices
    • more appropriately align level regulation with the actual risk posed by certain types of products
  • The review did not cover cell, tissue and blood regulation, clinical trials nor aspects of TGA’s governance or structure

Slide 17 - Seven bundles of work agreed and costed

  1. Increasing Flexibility for Registration and Post-Market Processes for Medicines
  2. Increasing Flexibility for Approval and Enhanced Post-Market Monitoring of Medical Devices
  3. Increasing Flexibility for Pre-Market Approval and Increased Evidence of Efficacy of Complementary Medicines for Consumers
  4. Simplified and More Effective Regulation of Advertising
  5. Streamlined Regulation of Patient Access to Therapeutic Products
  6. Further Reviews
  7. Rationalisation of TGA Statutory Advisory Committees

Slide 18 - Complementary medicines changes

  1. Streamline transparency and predictability of regulation:
    • Better regulatory guidance materials
    • Catalogue of approved ingredients
    • Introduce permitted indications for Complementary Medicines
    • Adopt/ develop evidence monographs
    • Right of review for applicant of TGA decisions on ingredients
    • Establish ingredient assessment timeframes
    • Continue stakeholder input through an advisory committee

Slide 19 - Complementary medicines changes

  1. Increasing the transparency of evidence of efficacy for particular indications
    • Sponsors encouraged but not mandated to publish efficacy evidence
    • Greater education on what AUST-L means, but sponsors not required to publish a label disclaimer
    • A new class of complementary medicines with efficacy assessed by TGA prior to market authorisation. Sponsors allowed to make higher-level claims than listed CMs.
    • Closer linkage to advertising claims
  2. More use of overseas assessments for new ingredients

Slide 20 - Complementary medicines changes

  1. Increased post-market monitoring and compliance
    • More products to be subject to random and targeted post-market review
    • Timely information on products subject to post-market review
    • Recommendation that TGA is able to refuse to list particular products
      • Intent able to be achieved through current mechanisms
      • i.e. allowing CMs to contain only permitted ingredients and targeted reviews by TGA of products immediately post-listing
  2. Improving the competitiveness of the complementary medicines industry by providing incentives for innovation
    • Could include consideration of data protection
    • Also use of new “listed-plus” pathway

Slide 21 - OTC medicine changes

  • No changes to the OTC evaluation framework as successful business process reforms in 2012 and reduced evaluation times
  • Notification of many variations by sponsors to TGA rather than requiring evaluation where the variation does not impact quality, safety or efficacy of the product
  • Enhanced electronic reporting of adverse events and enhanced information-sharing with overseas regulators

Slide 22 - Further reviews to be undertaken

  • In scope
    • Medicines Scheduling Policy Framework
    • Schedule 3 medicine advertising guidelines
    • Review regulation of lower-risk medicines
  • Proposed process
    • Document the basis of current approaches, approach of other regulators, and alternative frameworks
    • Conduct stakeholder workshops
    • Consultation papers and formal feedback on options
    • Provide advice to Minister on options
    • Ministerial decision, change to regulations?

Slide 23 - Scheduling policy framework

Regulation 52E Secretary to take certain matters into account in exercising powers

  1. In exercising a power under subsection 52D(2), the Secretary must take the following matters into account (where relevant):
    1. the risks and benefits of the use of a substance
    2. the purposes for which a substance is to be used and the extent of use of a substance
    3. the toxicity of a substance
    4. the dosage, formulation, labelling, packaging and presentation of a substance
    5. the potential for abuse of a substance
    6. any other matters that the Secretary considers necessary to protect public health.

Slide 24 - SPF - considerations for reform

  • Risk-benefit balance
    • Is there an excessive focus on risk?
    • Are the scheduling decision criteria appropriate?
    • Would a formal risk-benefit framework assist in decision making?
  • Decision-making transparency
    • Clarify requirements for scheduling submissions?
    • Publish applications (or a summary)?
    • Publish committee deliberations?
  • Decision-making principles
    • Clarify the cascading principles?
    • Clearer policy framework around unscheduled medicines?
    • Consider impacts of scheduling decisions on the wider health-system?

Slide 25 - SPF - considerations for reform

  • Information availability and input to decision-making
  • Governance
    • A forum for oversight of the SPF?
    • Enable scheduling decisions to be reviewed?
  • Business processes
    • Streamline timeframes and reduce rigidity?
    • Parallel registration and rescheduling proposals?
    • Rescheduling of classes of products?
    • Develop a process for identification of rescheduling candidates?
  • Incentives for rescheduling
    • Provide limited market exclusivity for products with the rescheduled substance?

Slide 26 - S3 (pharmacist only) medicines advertising

  • Currently only a limited number of S3 medicines can be advertised
  • The Expert Panel found very diverse views on possible change
    • And whether the current situation led to unnecessary GP visits
  • Government has asked for more specific consultation to be conducted
  • Options canvassed by stakeholders in 2015 workshops, included:
    • Make no change to the current system
    • Move instead to having a small list of substances forbidden from advertising
    • Move to a self-regulatory approach
    • Review overseas practices and experience
    • Allow ‘information provision’ by industry but not advertising

Slide 27 - Further reviews: low risk products

Recommendation Fourteen

The Panel recommends that the Australian Government undertake a review of the range of products currently listed in the ARTG (not including complementary medicines) and subject to regulation under the medicines framework, with a view to ensuring that:

  1. Products that might best be regulated under other regulatory frameworks, without undermining public health and safety, are removed from the auspices of the Act; and
  2. Goods remaining under the auspices of the Act are subject to regulatory requirements that are commensurate with the risk posed by the regulated products.

Slide 28 - Further reviews: low risk products

Recommendation Twenty-three

The Panel recommends that the Australian Government undertake a review of the range of products currently classified as Class I medical devices, with a view to reclassifying products as consumer goods in circumstances where the product poses little or no risk to consumers should it not perform as specified or malfunctions.

Recommendation Forty-eight

The Panel recommends that the Australian Government undertakes a review of the range of complementary medicinal products, currently listed in the ARTG and subject to regulation under the medicines framework, with a view to ensuring that products that might best be regulated under other regulatory frameworks, without undermining public health and safety, are removed from the auspices of the Act.

Slide 29 - Next steps: identify product types in scope

  • Water-soluble vitamins and minerals, homeopathic products?
  • Medicated lozenges
  • Primary and secondary sunscreens
  • Disinfectants, medicated soaps and toothpastes, nappy rash treatments
  • Some class one medical devices
  • Sanitary tampons
  • Other products?

Slide 30 - Next steps: develop a risk framework

  • For medicinal products, this could include parameters such as:
    • safety of the ingredients
    • route of administration
    • risk associated with the claims including labelled use
    • nature of the condition being treated/ prevented
    • nature and number of the population using the product
    • impact of poor manufacturing quality on safety/efficacy
  • Regulatory ‘familiarity’ does this reduce uncertainty or actual risks?
  • What is the ability of sponsors to objectively self-assess the product?
  • Look at international experience/alternative regulatory approaches

Slide 31 - SME regulatory assistance and clearer regulatory guidance

  • Aim is to help small business navigate the ‘regulatory maze’ through advice, guidance documents and workshops
  • Builds on work by TGA Regulatory Assistance Team over recent years
  • Would not replace detailed product-specific advice provided by regulatory consultants

Slide 32 - Other Recommendations

  • Deferred: Comprehensive review of the Therapeutic Goods Act and Regulations
  • Deferred: The Government review and enhance TGA’s funding
  • Not accepted: Chief Medical Officer to become decision maker (rather than TGA delegate) for all medicine and device decisions
  • Maintained: Complementary medicines advisory committee

Slide 33 - Advertising of therapeutic goods

  • Public advertising of therapeutic goods continues to be regulated by TGA under a framework which includes an advertising code
  • Abolish mandatory pre-approvals of advertising, and move to a self-regulatory regime – will need strong and timely compliance powers
  • New mechanism for managing complaints managed in a streamlined process through a single agency
  • Investigation and enforcement powers to be broadened
  • TGA to run sponsor education programs to assist in compliance

Slide 34 - How will we pay for the reforms?

  • Government agreed that we could use TGA reserves (and 2015/16 surplus) to pay for cost of design of reforms and implementation of new systems
  • Separately a systematic evaluation of appropriate fees and charges will be needed:
    • For new (e.g. enhanced comp meds compliance) and existing activities
    • So fees and charges may change

Slide 35

A great opportunity to implement important reforms … but must avoid diverting resources from ‘business as usual’ regulatory work

Slide 36 - Implementation and Governance

  • A broad plan for implementation of reforms over the next 18-24 months has been agreed by Government
  • Project teams have been established at TGA around each priority area
  • Some consultations will be targeted (e.g. regulatory business processes) while public consultations will be held on areas of broader public health interest
  • We will soon publish a timetable for the initial group of stakeholder consultations

Slide 37 - Implementation and Governance

  • A broad plan for implementation of reforms over the next 18-24 months has been agreed by Government
  • Project teams have been established at TGA around each priority area
  • Some consultations will be targeted (e.g. regulatory business processes) while public consultations will be held on areas of broader public health interest
  • We will soon publish a timetable for the initial group of stakeholder consultations

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