Consultation Hub

We asked for feedback on proposals to remake some of the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021.

We received 33 submissions in response to the consultation, including from government, sponsors, industry organisations, as well as from individual consumers. There was broad support for the remaking the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), with proposed amendments. Responses from the eye banking sector did not initially support some proposed changes.  Post consultation negotiations with eye banks and their peak industry body, the Eye Bank Association of Australia & New Zealand, negotiated a three year transition period for the introduction of additional donor testing requirements.

In addition, stakeholders provided a range of views and suggestions to improve the standard, including:

• Label requirements too onerous for biologicals not for supply in Australia.
• Introduce risk-based assessments as an alternative for HTLV serological testing for donor screening requirements.
• Donor history requirements specified in TGO 108 as burdensome for ‘export only’ plasma for fractionation (PFF).

The changes proposed in the public consultation and above referenced feedback have been incorporated in the final standards.

Some feedback was not accepted as matters either affected or were beyond scope of the quality, safety, efficacy of therapeutic goods.

Thank you to everyone who provided feedback and helped in the development of the standards.

Most changes proposed in the standards are deregulatory or the current sponsors already comply with the new requirements.

To allow sponsors to meet the quality system requirements a 12-month transition period will be allowed for all standards from 1 October 2021 to 30 September 2022.  During this time the former Orders may be conformed with, despite being repealed, as an alternative to the new standards.

The exception to this are donors whose ocular tissue will be released for supply solely for the purpose of corneal transplantation (‘cornea only donors’). TGO 108 will now mandate additional serological testing for human T cell leukaemia virus types 1 and 2 (HTLV-1/2) and syphilis, with nucleic acid amplification testing (NAT) for human immunodeficiency virus types 1 and 2 (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) for these donors. An extended transition timeframe of 3 years for ‘cornea only donors’ from additional donor testing requirements in TGO108 to allow adequate time for availability of appropriate testing facilities in some states and territories.  The extended transition time takes into consideration of absence of any safety signals and negligible risk of transmission of infectious diseases with aims to drive the sector towards international regulatory best practice approach.

The new orders come into effect on 30 September 2021.The Therapeutic Goods (Biologicals - Specified Things) Instrument 2021 also comes into effect on 30 September 2021.

To help explain the requirements and relationship with sunsetting standards, TGA has published guidance and tracking documents on TGA website. The guidance documents also incorporate stakeholder feedback on the draft guidance included in this consultation in May 2021.

Published responses

View submitted responses where consent has been given to publish the response.

We asked for feedback on proposals for improving the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The proposals included changes to provisions of the Code that had been identified as being unclear, inconsistent, or otherwise difficult to work with. The proposals were designed to improve advertising compliance, minimise advertising compliance costs, and ensure Code provisions work as intended.

We canvassed stakeholder preferences for different options for some provisions. We also invited stakeholders to identify other areas where the Code could be improved.

We received 67 submissions in response to the consultation, including from sponsors, manufacturers, advertisers, marketers and sellers of therapeutic goods, peak industry bodies and associations, regulatory affairs firms, policy advocates, and health professional and consumer organisations. There was broad support for amending the Code to reduce complexity and increase clarity for users. Stakeholders also advocated for a review of current guidance on the Code to ensure it remains contemporary and easily accessible.

On some proposals, there were widely divergent views:

• There was broad support for clarifying the requirements around claims in advertising, including ‘therapeutic’ and ‘non-therapeutic’ claims, and the evidence requirements for each. But there was a divergence of views as to whether this should be done in the Code, or in guidance.
• The proposal to strengthen the rules around the use of language and images in advertising that may invoke a sense of fear or distress in consumers also produced a range of views.
• Stakeholder views about who should and who should not be allowed to make product endorsements and testimonials for use in advertising were widely divergent.
• There was also a range of views around the rules relating to advertising involving the offer or provision of free samples of goods, and the criteria that should apply when determining what types of goods should be exempted from any general restrictions on this practice.

However, stakeholders broadly supported the introduction of alternative mandatory statements in advertisements for typically ‘non-consumer’ therapeutic goods. Many stakeholders also indicated they wanted simpler rules around the use of existing mandatory statements and health warnings in advertisements.

Thank you to everyone who provided feedback.

In response to this feedback, we have decided to re-write the Code using a simplified structure and plainer language. We will also ensure the guidance on the Code is more accessible and user-friendly.

On specific Code issues, we are reflecting on feedback and undertaking further targeted consultations with members of the Therapeutic Goods Advertising Consultative Committee.

We aim to prepare and publish the new Code by the end of 2021. Please subscribe to the TGA Advertising email list to be notified of progress.

We asked for feedback on a proposed standard for nicotine vaping products that have not been assessed by the TGA (unregistered nicotine vaping products). While it is possible that in the future there may be nicotine vaping products that have been assessed and approved by the TGA as medicines, we expect that in the meantime there will be a significant number of prescriptions written for unapproved goods for smoking cessation. We proposed a set of minimum safety and quality requirements for unregistered nicotine vaping products to support health professionals and consumers in knowing what is in the product being prescribed and used and to reduce the risks of accidental poisonings.

In this consultation we also asked for feedback on a proposal to exempt those unregistered nicotine vaping products that meet the requirements in the proposed standard from having to meet certain other default standards in the European Pharmacopoeia and the United States Pharmacopeia. 

We received 103 submissions in response to the consultation, including from research, government, health professional, consumer and industry organisations, as well as from individual consumers. There was broad support for the creation of a standard for unregistered nicotine vaping products. Respondents provided a range of views and suggestions to improve the standard, including:

• more strict labelling requirements, such as the need for a consistent measure of the concentration of nicotine in the product and clear rules about which label warning statements (e.g. ‘KEEP OUT OF REACH OF CHILDREN’, ‘Avoid contact with eyes’, ‘Avoid contact with skin’)
• the need for accurate labelling of nicotine concentration or content in the product
• information about additional ingredients associated with known inhalation harms
• diverse views on whether the standard should specify limits on nicotine concentration, container volume and flavours
• a preference that the standard also apply to products that may be listed on the Australian Register of Therapeutic Goods (ARTG) in the future as ‘Export Only’ medicines
• suggestions about different types of information manufacturers and others should be expected to hold about the products
• requests for the regulation of vaping devices.

Thank you to everyone who provided feedback and helped in the development of the standard.

In response to this feedback, the standard includes updated labelling requirements for nicotine concentration (including requiring nicotine concentration to be specified in mg/mL and warning statements to be provided), the prohibition of three additional ingredients with established inhalation risks, record keeping requirements for sponsors, a limit of nicotine concentration of 100 mg/mL in products and a requirement for actual nicotine concentration/content of a product to be within +/- 10% of what it says on the label. The standard has also been expanded to cover ARTG-listed ‘Export Only’ products.

Although the standard does not restrict the flavours of nicotine vaping products (other than those containing prohibited ingredients) or container sizes, it is important to remember that these factors, and others, are restricted by the person’s prescription. This allows the prescribing health professional and patient to work together to make sure that the right product is supplied to support nicotine and smoking cessation.

The new Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 was published in May 2021 and comes into effect on 1 October 2021. This standard will apply to all unregistered nicotine vaping products in Australia (including compounded and clinical trial products and ARTG-listed as ‘Export Only’ products).

The Therapeutic Goods (Exempt Monographs) Determination 2021 (“the Determination”) was made at the same time as the standard. The purpose of the Determination is to exempt unregistered nicotine vaping products from certain pharmacopoeial standards that automatically apply to therapeutic goods.

To help explain the new requirements, TGA has published final guidance on the requirements of TGO 110 and other matters related to nicotine vaping products and vaping devices. The final guidance incorporates stakeholder feedback on the draft guidance published in May 2021.