Regulatory Reforms at the Therapeutic Goods Administration (TGA) Dr - - PowerPoint PPT Presentation

Regulatory Reforms at the Therapeutic Goods Administration (TGA)

Dr Mark McDonald Assistant Secretary Regulatory Reforms, TGA 2017 ARCS Annual Conference

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

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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

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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

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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

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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
• ther 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?

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To Regulate or Not to Regulate

• TGA regulatory frameworks

– Exempt goods – Excluded goods

• Consumer goods (ACCC)

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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

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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?

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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

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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

• f Melbourne
• The basic principle of the LCRS
• This approach is increasing used to publicly rate hotels and restaurants

(e.g. on “Trip Advisor”), car smash repairers and even health care providers

“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

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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.

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‘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

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‘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

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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

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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

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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

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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.

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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

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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

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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

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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 certain vitamins and minerals not to be therapeutic goods

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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

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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

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Where are we up to?

• Public consultation on the “Options for the future regulation of ‘low risk’

products” has been completed and analysed

• Specific policy proposals are being developed for Ministerial consideration
• Following Ministerial endorsement of proposals, implementation proposals will

be developed and consulted

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Class I medical devices

Proposed next steps:

• 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

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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

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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

• n 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).

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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

• f 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 Further process improvements 5 To improve, clarity and communication

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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
• Government has asked for more specific consultation to be conducted
• 2017 consultation asked stakeholders for their feedback on possible options in order to develop a

new framework for the advertising of these substances. Options 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

• There was strong support to increase advertising of Schedule 3 substances, with a particular

emphasis on public health awareness. Current work is focused on developing a mechanism, utilising existing framework to allow more S3 substances to be advertised

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Timeline for Scheduling Review

Advertising Reform (including S3) consultation September 2017 Revised advertising code (including S3) to be consulted Mid 2018 implemented SPF policy and handbook being drafted Public/Targeted consultation AHMAC consideration of revised SPF/handbook December 2017 Implementation to commence Start of 2018 Regulation change (if required as part of bulk legislative change)

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Questions?

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Find out more:

www.tga.gov.au/mmdr MMDR.consultation@health.gov.au tgaregreforms@health.gov.au