The future regulation of low risk products

Background

The Government accepted recommendations 14, 23 and 48 from the Review of Medicines and Medical Devices Regulation (MMDR review) to carry out further reviews of the regulation of 'low risk' products.

The Government required the Therapeutic Goods Administration (TGA) to examine whether the regulatory oversight applied to a range of products that represent a very low safety risk to consumers was consistent with the principles of best practice regulation, and further whether there were any opportunities for streamlining or simplifying current regulatory requirements for these products.

In conducting the further reviews, a series of targeted stakeholder consultations were held during late 2016 and early 2017. A range of options for the future regulation of low risk products was released for public consultation on 31 March 2017 and over 1,000 submissions were received in response. The proposed options for reform spanned from retaining the status quo to exclusion or exemption from the therapeutic goods regulatory framework. Following analysis of consultation responses, a range of reform activities have been endorsed by Government.

Important terms

There are a number of important terms used that represent different types and levels of regulatory oversight applied to low risk therapeutic goods:

Non-prescription (Lower risk) registered products

Products in this category are considered to be lower risk than prescription medicines. However, they still require a high level of scrutiny, for example to ensure adequate labelling for appropriate use. Examples of products in this category are mild analgesics, cough and cold medicines, and anti-fungal creams. All registered medicines must display an 'AUST R' number on the label as proof of registration and are evaluated as either 'high risk' or 'low risk' registered.

Medicines assessed as having a higher level of risk must be registered. The degree of assessment and regulation they undergo is rigorous and detailed, with sponsors being required to provide comprehensive safety, quality and efficacy data.

Listed medicines

These are products that are required to be entered in the Australian Register of Therapeutic Goods (ARTG) but without prior assessment by the TGA. These products must only contain ingredients from an approved list and can only make claims selected from a list of pre-approved low level indications to ensure that the products do not overstate their therapeutic benefits.

They must also be manufactured in Good Manufacturing Practice (GMP)-compliant facilities. Sponsors must hold efficacy evidence and provide this evidence on request to the TGA. They must comply with standards for product quality, labelling and packaging, and with advertising rules. They are subject to the TGA recall provisions. Examples include vitamin tablets, herbal medicines and sunscreens.

Class I medical devices

The lowest risk medical devices, Class I devices, are not assessed by the TGA prior to inclusion in the ARTG. The level of scrutiny by the TGA of a device before it is placed on the ARTG and supplied in Australia depends on the risk posed by the device.

Listed Other Therapeutic Goods (OTG)

These are products that are required to be entered into the ARTG following pre-assessment by the TGA.

They are not required to be manufactured in GMP-compliant facilities. Sponsors must hold efficacy evidence and provide this evidence on request to the TGA. They must comply with labelling and packaging and advertising requirements. They are subject to the TGA recall provisions. Examples include ear candles, tampons and menstrual cups.

Exempt goods

These are products that are therapeutic goods and fall under the TGA's oversight, but with exemptions from meeting certain legal requirements (which represents a considerably lower regulatory burden).

In the context of these reforms, exemptions relate to entry in the ARTG and GMP compliance, however these goods remain subject to the remainder of controls as described under listed medicines above. Examples of exempt goods include un-medicated anti-acne preparations having only a cleansing action and household disinfectants without specific claims.

Excluded goods

Excluded goods are not regulated as part of the therapeutic goods framework, but are primarily governed by Australia Consumer Law (ACL), administered by the ACCC. Examples include household and personal aids, furniture and utensils for people with disabilities, dental bleaches and dental whiteners.

Consultation submission

Responses to the public consultation have been published on the TGA website.

Having considered these responses, the Government has decided on a range of options for the future regulation of low risk products. These activities are summarised below.

What is not changing - maintaining the status quo

Water soluble vitamins and minerals

Vitamin and mineral products currently covered by the regulatory scheme will continue to be treated as complementary medicines and regulated as either listed or registered medicines under Therapeutic Goods Act 1989 (the Act).

Sunscreens

The will be no changes to the way sunscreens are regulated in Australia, however a number of ongoing activities will be pursued to reduce regulatory burden associated with these products.

Based on use of overseas reports the TGA will be developing a new, more transparent and predictable pathway for approval of new active ingredients for sunscreens. We will also seek to define alternative quality standards for the non-active ingredients and excipients in sunscreens.

GMP for sunscreens

In recognition of sunscreens being a low risk topical listed product and not a prescription medicine, the TGA has developed the guidance document Sunscreen manufacturing: demonstrating compliance with the PIC/S Guide to GMP PE009-13 in consultation with a working group of industry representatives.

What is changing - the following product types will become exempt from specified regulatory requirements

Tampons and menstrual cups

Tampons and menstrual cups are currently regulated as Other Therapeutic Goods. This will change to allow tampons and menstrual cups to become exempt goods and no longer require listing in the ARTG, however Therapeutic Goods Order (TGO) 82 (Standard for Tampons - Menstrual) will continue to apply to tampons as the enforceable safety standard.

Exempting these goods will mean they no longer require assessment by the TGA which will allow these products to have faster and less costly access to the Australian market.

Nappy rash cream (treatments)

Nappy rash treatments in Australia are topical products that range from listed medicines that are indicated to provide a 'soothing effect' through to registered products, mostly anti-fungal preparations that are aimed at treating severe cases of skin irritations cause by fungal infections. There are also topical cream products included in the ARTG as Class I medical devices because their mode of action is considered to be physical in nature.

Some nappy rash products that are currently included in the ARTG as Class I medical devices or as listed medicines, will be declared exempt. For the purpose of the exemption, these products will be considered therapeutic goods and will continue to be required to meet applicable standards for product quality, labelling and packaging, and with advertising requirements.

There will be no changes to nappy rash products that are entered in the ARTG as registered medicines.

The changes were made to the regulation of nappy rash products on 1 January 2020.

Hard surface disinfectants

Hard surface disinfectants are regulated by the TGA and form part of the other therapeutic goods group. Hard surface disinfectants include hospital, household and commercial grade disinfectants. TGO 54 (Standard for Disinfectants and Sterilants) details minimum performance requirements for each grade of disinfectant or sterilant as well as the requirements for product packaging and labelling.

The TGA is proposing to streamline the current regulatory pathway for hard surface disinfectants.

Hard surface disinfectants that are currently listed (hospital grade without specific claims) will be exempt from the requirements of entry in the ARTG. They will continue to be required to comply with TGO 54.

Registered hard surface disinfectants with specific claims will be moved from the registered to listed other therapeutics goods (OTG) pathway that will result in streamlining the depth of pre-market assessment required for these products and thus reducing unnecessary regulatory burden on the sponsors.

Pre-market review of listed disinfectants will only be conducted on new ingredients and/or new specific claims.

In addition to streamlining the regulatory pathway, the approval process for new disinfectant ingredients will be made more transparent and predictable and will possibly include the increased use of comparable overseas regulator reports.

Finally, TGO 54 itself will be updated to better align with contemporary expectations and standards. We expect that this will include: clearer definitions and performance requirements to demonstrate efficacy for specific claims for listed products; a simplified pathway for approval of new active ingredients, to enable greater use of international reports, and a review of the uses and definition of 'Hospital Grade' when used in the context of hard surface disinfectants.

The following product types will become excluded

Antiperspirants

In Australia, the term "Antiperspirants" meets the definition of a 'therapeutic good' within the Act because the definition of therapeutic use under the Act includes: "...influencing, inhibiting or modifying a physiological process in persons...".

Antiperspirants that derive their antiperspirant properties from inorganic salts of aluminium, zinc or zirconium only, are already exempt medicines. However, antiperspirants are viewed by consumers as toiletries, and regulation as medicines adds few meaningful safeguards.

Government has decided that all topical antiperspirant preparations which are declared exempt will be excluded from the therapeutic goods regulatory framework.

Ear candles

Ear candling is an alternative medical practice that involves inserting and lighting a hollow candle (ear candle) in the ear canal.

Ear candles are currently regulated by the TGA as listed other therapeutic goods and require entry in the ARTG. They are exempt from GMP requirements, but must comply with labelling requirements under TGO 37 (General Requirements for Labels for Therapeutic Devices (07/02/1991)) and are subject to post market compliance reviews, recall procedures and therapeutic goods advertising compliance. However the claims made by these products are consistent with cosmetic or personal hygiene, and therefore these products are more appropriately considered as consumer goods.

The Government has decided that ear candles will be excluded from the therapeutic goods regulatory framework.

Ongoing activities

Class I medical devices

A pre-market review by the TGA is not required to include Class I medical devices in the ARTG. The TGA does, however, have responsibility for post-market vigilance of these products once they are included in the ARTG.

We are aware that a number of Class I medical devices would be more appropriately considered consumer goods (such as hospital furniture) and these products have been incorrectly included in the ARTG as therapeutic goods. To remove excessive regulation we are reviewing all Class I medical devices in the ARTG to ensure they meet the requirements for inclusion. Product types that are identified as not meeting these requirements will be removed from the ARTG.

TGA has developed guiding principles for determining which products are very low risk and therefore excluded from regulation under the Excluded Goods Determination. Information is available at Medical devices reforms.

Over the Counter (OTC) products

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 contain unscheduled substances and are currently for general sale.

These low risk registered OTC products will be reviewed to determine if the active ingredients in some products should become listed, thereby decreasing the regulatory burden. Products for consideration include: desensitising toothpastes, mouth washes, antiseptics, antimicrobial lozenges, certain antacids, wart plasters, inhalers and chest and heat rubs, certain laxatives and antidandruff shampoos.

Rehydration/sports drinks

These 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.

Rehydration products for therapeutic purpose have historically been considered medicines and regulated as either listed or registered products depending on the claims and composition of the products. They must be entered in the ARTG prior to supply in Australia and manufacturers must have medicine level GMP.

Rehydration/sports drinks will be considered as part of the ongoing work on the food/medicine interface to develop a clearer demarcation between sports drinks, more appropriately regulated as foods, and other oral rehydration products with a specific therapeutic purpose.

Aromatherapy and homeopathy products

The Government is yet to determine what would be an appropriate level of regulation for aromatherapy and homoeopathic products. Further consultation with affected stakeholders may be required.

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Version history

Version	Description of change	Author	Effective date
V1.0	Original publication	Therapeutic Goods Administration	21/06/2018
V1.1	Addition of section on GMP for sunscreens	Therapeutic Goods Administration	16/10/2018
V1.2	Update to sections on Disinfectants and Class I medical devices	Therapeutic Goods Administration	18/12/2018
V1.3	Update to section on Nappy rash cream (Treatments)	Therapeutic Goods Administration	26/07/2019
V1.4	Removal of next steps. Update to sections on Nappy rash cream (Treatments), Hard surface disinfectants, and Class I medical devices.	Therapeutic Goods Administration	13/04/2023