TGA presentation: ARCS Webinar, 28 April 2017

Regulatory Reforms at the Therapeutic - Goods Administration (TGA)

22 May 2017

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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.

Presentation

  • Presented by: Dr Mark McDonald
  • Presented at: ARCS Webinar
  • Presentation date: 28 April 2017
  • Presentation summary: An overview of recommendations from the Review of Medicines and Medical Devices Regulation relating to low risk therapeutic goods.

Transcript

Regulatory Reforms at the Therapeutic - Goods Administration (TGA)

Dr Mark McDonald
Regulatory Reforms, Therapeutic Goods Administration

ARCS Webinar, 28 April 2017

Slide 1 - About the TGA (briefly)

  • Part of the Commonwealth Department of Health, but separately located and with its own strong external brand
  • HQ in Canberra with 5 satellite offices
  • Approx. 700 staff plus 80 contractors: scientists, engineers, toxicologists, technicians, medical officers, pharmacists, lawyers and administrative staff
  • Budget of $150m pa
  • Virtually all of TGA's operations are cost recovered from industry fees and charges - unique globally among medicines and device regulatory bodies

Slide 2 - Locations

  • The majority of TGA staff are located at the Symonston site in Canberra
  • This building has combined office space with extensive scientific laboratories
  • Some TGA are co-located with Department of Health colleagues at the Department’s Central Office in Woden
  • TGA also has staff in Sydney, Melbourne, Adelaide and Brisbane

Slide 3 - TGA's role

  • Regulate therapeutic goods including prescription, over-the-counter and complementary medicines, medical devices, biologicals, blood and blood products
  • Evaluates therapeutic goods before they are marketed and monitors products once they are on the market
  • Assesses suitability of medicines and devices for export
  • Focuses on safety, efficacy and quality
  • Works closely with consumers, health professionals, industry and international counterparts

Slide 4 - Department of Health

Organisational Structure

Secretary

  • Chief Operating Officer
  • Strategic Policy and Innovation
  • Health Benefits
  • National Program Delivery
  • Health Products Regulation
  • Health Protection / CMO
  • Special Adviser: Strategic Health Systems and Information Mgt

Slide 5 - Risk management

All therapeutic goods have some level of risk.

Our role is to see that benefits outweigh known risks Management of uncertainty is a greater challenge.

TGA's approach to risk management involves:

  • identifying, assessing and evaluating the risks posed by therapeutic products
  • applying any measures necessary for treating the risks posed
  • monitoring and reviewing risks over time.

Slide 6 - Can regulators manage uncertainty well enough?

  • Regulators have frameworks for assessing benefits and harms (risk) but less with uncertainty
  • Uncertainty and harms can be confused, with negative consequences for decision making
  • A balance between the two is needed, combining the science with an appropriately designed regulatory framework

Slide 7 - 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
  • Health Minister took preferred position to Cabinet
  • Government response was publicly released on 15 September 2016

Slide 8 - 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

Slide 9 - Further reviews to be undertaken

In scope

  • Medicines (and chemicals) 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 10 - To Regulate or Not to Regulate

  • TGA regulatory frameworks
    • Exempt goods
    • Excluded goods
  • Consumer goods (ACCC)

Slide 11 - Guiding principles of the review

  • Not our intention to fundamentally change the definition of a medicine or medical device
  • What is the purpose of our regulation
  • Considered the concept of 'regulatory familiarity' of particular products
  • Recognised that moving some product types to regulation by Food Standards Australian New Zealand (FSANZ) or under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) are not necessarily options that provide for decreasing regulation.
  • Australian Consumer Law provides for default Australian Competition and Consumer Commission (ACCC) oversight of all consumer goods in Australia under Australian Consumer Law, including therapeutic goods used by consumers.

Slide 12 - 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 13 - Next steps: Develop a risk framework

  • How to define "low risk"?
  • 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 14 - Low Risk Classification System

  • To objectively determine if products are 'low risk' the TGA developed a Low Risk Classification System (LRCS) in consultation with experts in this area from the University of Melbourne
  • The basic principle of the LCRS

    The basic principles of the LCRS

    • "Wisdom of crowds" - Linear model
      • Rate: Experts qualitatively rate a product on each of six criteria
      • Combine: Take average of ratings on each criterion
      • Weight: Multiply averaged ratings by criteria weights
      • Sum: Calculate a product's Score as sum of weighted ratings
      • Classify: Low Risk if Score Less than Threshold
  • This approach is increasing used to publicly rate hotels and restaurants (e.g. on "Trip Advisor"), car smash repairers and even health care providers

Slide 15 - So what was considered 'low risk'

In the context of Recommendation 14 of this review the following was considered 'low risk':

  • Ear candles
  • Nappy rash creams
  • Antiperspirants
  • 'Low risk' OTC medicines
  • Hard surface disinfectants
  • Sunscreens
  • Tampons and menstrual cups
  • TGA developed a range of possible options that represent potential future regulatory approaches.

Slide 16 - 'Low risk' OTC medicines

A number of well-known OTC products that have a long history of use at particular ingredient levels and dosage forms have been identified as 'lower risk'.

These product types include:

  • Registered desensitising toothpastes
  • Antiseptics for first aid treatment of minor cuts and abrasions
  • Lozenges for relief of sore throats (these contain anti-microbial active ingredients)
  • Antacids - containing carbonates, hydroxides, silicates, and/or alginates (but not medicines containing a proton pump inhibitor or H2 antagonist)
  • Salicylic acid plasters for removal of corns and warts
  • Menthol-based inhalers and chest rubs

Slide 17 - 'Low risk' OTC medicines

Product types continued:

  • Antiseptic mouth washes
  • Acne treatments containing benzoyl peroxide
  • Rubefacient preparations for minor aches and pains of muscles (e.g. methyl salicylate, menthol, capsicum) but not creams or ointments containing a non-steroidal anti-inflammatory medicine
  • Certain laxatives

Options

  • Maintain the status quo regulation
  • Review the eligibility of active ingredients to become Listable

Slide 18 - Hard surface disinfectants

Issues identified by stakeholders with the current framework include:

  • Regulatory requirements are confusing
  • Timeframes for application processing are very long
  • Safety evaluations for different formulations are expensive

Range of options:

  • Maintain the status quo regulation of hard surface disinfectants
  • Streamline the regulatory framework for hard surface disinfectants
  • Develop a series of monographs
  • Approval process for new ingredients
  • Declare hard surface disinfectants not to be therapeutic goods

Slide 19 - Sunscreens

Issues identified by stakeholders with the current framework include:

  • Medicine level GMP
  • Process for review of new ingredients slow and expensive
  • Application of pharmacopeial standards for all ingredients
  • Different levels of regulation confusing

Range of options:

  • Maintain the status quo regulation of sunscreens.
  • Streamline the regulatory pathways for sunscreen regulation.
  • Prevent all secondary sunscreens from making SPF claims.
  • Creation of a GMP standard for primary sunscreens.
  • New ingredient approval process.
  • Alternative ingredient standards for excipients.
  • Exclude all sunscreens from the regulatory framework.

Slide 20 - So what was considered 'low risk'

Recommendation 23 was the review of Class I medical devices.

  • To maintain international harmonisation we did not want to fundamentally change the classification system for medical devices.
  • Whilst trying to identify candidates for consideration it was recognised that there is a significant number of potentially non therapeutic goods in the ARTG.
  • Proposal is to clean up the ARTG to remove the 'white noise' before taking a look at those remaining Class I medical devices, and consider any further regulatory changes.

Slide 21 - Proposed next steps for Class I medical devices

  • Systematic review of ARTG to identify non therapeutic goods
  • Engage with States and Territories Health department procurement branches
  • Update the Excluded Goods Order
  • Review the Class I medical device ARTG entry process

Slide 22 - So what was considered 'low risk'

In the context of Recommendation 48 of this review the following was considered 'low risk':

  • Aromatherapy products
  • Rehydration or formulated sports products
  • Certain vitamins and minerals
  • Homoeopathic products

Again, TGA developed a range of possible options that represent future regulatory approaches.

Slide 23 - Aromatherapy products

Aromatherapy uses essential oils for the purpose of altering one's mood, cognitive, psychological or physical wellbeing.

Issues with the current approach include:

  • the purpose of a product containing an essential oil determines which part of government regulates it.
  • The difference between therapeutic and cosmetic products can be confusing.

Range of options:

  • Maintain the status quo regulation of aromatherapy products
  • Exemption from listing in the ARTG and/or GMP
  • Declare essential oils not to be therapeutic goods

Slide 24 - Rehydration or formulated sports products

Issue with the current approach include:

  • confusion at the food-medicine interface
  • the dosage forms for these products range from sachets of oral powders and effervescent tablets to ice blocks and ready to drink solutions.
  • rehydration products are similar in composition and presentation to electrolyte drinks, also known as sports drinks, which are beverages designed specifically for the rapid replacement of fluid, carbohydrates, and electrolytes.

Proposed further action:

  • Review of rehydration products on the ARTG to remove food claims to ensure clear demarcation between sports drinks and therapeutic rehydration products.
  • Slide 25 - Certain vitamins and minerals

    Not all of these supplements represent equal risk.

    • Water soluble vitamins (for example vitamin C) have a lower risk profile than fat soluble vitamins (for example vitamin A) as they are readily excreted from the body, whereas fat soluble vitamins have been associated with toxicity.
    • Similarly minerals such as calcium have a lower risk profile, compared to higher risk minerals which are included in a schedule of the Poisons Standard, such as some iron preparations.

    Slide 26 - Certain vitamins and minerals

    Issues with the current approach include:

    • the introduction of Standard 1.2.7 - Nutrition, Health and Related Claims in 2013 by Food Standards Australia New Zealand (FSANZ) has caused a significant change to the food/medicine interface
    • Some vitamin and mineral products are more akin to food or dietary supplements than medicines

    Range of options:

    • Maintain the status quo regulation of vitamins and minerals
    • Exemption from listing in the ARTG and/or GMP
    • Declare vitamins and mineral not to be therapeutic goods

    Slide 27 - Homoeopathic products

    • Homoeopathic preparations (4X and above) are exempt from being entered in the ARTG if they:
      • are not required to be sterile,
      • do not include ingredients of human or animal origin, and
      • do not make reference to serious diseases or conditions.
    • Preparations that meet these conditions are also exempt from requiring the manufacturer to hold a GMP licence

    Slide 28 - Homoeopathic products

    Issues identified with the current approach include:

    • Questionable evidence
    • Inconsistency in regulation for level of claims being made, ie homoeopathic products making high level claims must be listed. Other non homoeopathic products making high level claims are required to be registered.

    Range of options:

    • Maintain the status quo regulation of homoeopathic products
    • Serious therapeutic claims must be supported by scientific evidence.
    • Exemption from listing in the ARTG and/or GMP
    • Declare homeopathic products not to be therapeutic goods

    Slide 29 - The Scheduling Policy Framework - background

    • The SUSMP is the basis by which public access to medicines and chemicals is controlled.
    • Substances are placed into a schedule based on the risk associated with their use. Progression through the schedules signifies increasing restrictions.
    • For medicines: S2, S3, S4 and S8
    • For chemicals: S5, S6 and S7
    • S9: only available for teaching, research etc.
    • Decision making powers contained in the Therapeutic Goods Act 1989, i.e. delegates of the Secretary of the Department of Health make the actual scheduling decisions
    • The SPF provides the risk based decision making principles to be used by the decision maker - the scheduling decision is captured by the SUSMP
    • Implementation of the SUSMP is through relevant State and Territory legislation

    Slide 30 - SPF - considerations for reform

    Policy recommendations
    Governance 1 Split the SPF into a policy document and a guidance handbook.
      2 Establish an informal working group comprising state and territory representatives, industry, healthcare professionals and consumers to meet as required to provide advice on possible amendments to the SUSMP.
    Interim decision 3 Amend the Therapeutic Goods Regulations to allow general public consultation on the interim decision and where appropriate, enable the time available for submissions to be extended.
    Timing of decision 4 Explore options for establishing a chemicals scheduling delegate in APVMA to streamline scheduling and marketing authorisation considerations.
    Tools for better management of rescheduled substances 5 Create a new Appendix in the Poisons Standard (SUSMP) to enable additional controls or requirements for Schedule 3 substances to be specified, in particular for substances that have been down-scheduled from Schedule 4 (prescription only).

    Slide 31 - SPF - considerations for reform

    Ongoing improvements and development of guidance materials
    Decision-making principles 1 Undertake a trial to assess the value of applicants presenting to the advisory committees
    Risk:benefit value tree 2 Prepare worked examples of the risk:benefit tree for recent scheduling considerations and determine if there is utility for using as part of scheduling applications
    Proactive consideration of candidate substances for rescheduling 3 Implement a system for proactively identifying substances for rescheduling
    Parallel processes 4A Develop a possible mechanism for aligning prescription to OTC medicine rescheduling applications with applications to TGA for market authorisation of products containing the potentially rescheduled substances at OTC medicines
      4B Consider options for market incentives for down-scheduling

    Slide 32 - S3 (pharmacist only) medicines advertising

    • Currently only a limited number of S3 medicines can be advertised - managed through an appendix to the SUSMP
    • 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
      • Allow "information provision" by industry but not advertising
    • Current consultation is asking stakeholders for their feedback on these possible options in order to develop a new framework for the advertising of these substances

    Slide 33 - SPF Reform process

    SPF Reform process

    Stakeholder engagement

    Consultation paper

    Analysis of feedback[a]

    Further consultation if required[b]

    Possible implementation of reform January 2018[c]

    AHMAC

    Noted SPF review at December 2016 meeting

    • Notified of consultation feedback
    • Endorsement of proposed reform requested
    • June 2017 meeting

    Notified of consultation 2 feedback September 2017 meeting

    Endorsement of revised SPF or other reform December 2017 meeting

    Slide 34 - Questions?

    Any questions relating to consultation submissions can be directed to the Regulatory Reforms Team by email to

    Slide 35 - Find out more:

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