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 Regulatory Reforms at the Therapeutic Goods Administration 1
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 Regulatory Reforms at the Therapeutic Goods Administration 2
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 Regulatory Reforms at the Therapeutic Goods Administration 3
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 Regulatory Reforms at the Therapeutic Goods Administration 4
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? 5 Regulatory Reforms at the Therapeutic Goods Administration
To Regulate or Not to Regulate • TGA regulatory frameworks – Exempt goods – Excluded goods • Consumer goods (ACCC) Regulatory Reforms at the Therapeutic Goods Administration 6
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 Regulatory Reforms at the Therapeutic Goods Administration 7
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? Regulatory Reforms at the Therapeutic Goods Administration 8
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 9 Regulatory Reforms at the Therapeutic Goods Administration
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 “Wisdom of crowds” Linear model Rate Combine Weight Sum Classify Experts Take average of Multiply Calculate a Low Risk if qualitatively rate ratings on each averaged ratings product’s Score Score Less than a product on criterion by criteria as sum of Threshold each of six weights weighted ratings criteria • This approach is increasing used to publicly rate hotels and restaurants (e.g. on “Trip Advisor”), car smash repairers and even health care providers Regulatory Reforms at the Therapeutic Goods Administration 10
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. Regulatory Reforms at the Therapeutic Goods Administration 11
‘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 Regulatory Reforms at the Therapeutic Goods Administration 12
‘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 Regulatory Reforms at the Therapeutic Goods Administration 13
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 Regul atory Reforms at the Therapeutic Goods Administration 14
Sunscreens Issues identified by stakeholders with the current Range of options: framework include: • Maintain the status quo regulation of sunscreens • Medicine level GMP • Streamline the regulatory pathways for sunscreen • Process for review of new ingredients slow regulation and expensive • Prevent all secondary sunscreens from making • Application of pharmacopeial standards for SPF claims all ingredients • Creation of a GMP standard for primary • Different levels of regulation confusing sunscreens • New ingredient approval process • Alternative ingredient standards for excipients • Exclude all sunscreens from the regulatory framework Regulatory Reforms at the Therapeutic Goods Administration 15
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 Regulatory Reforms at the Therapeutic Goods Administration 16
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