By Dr Teresa Nicoletti, Partner and Helaena Short, Lawyer
The new regulatory framework for complementary medicines commenced in 2018 and all currently listed medicines may require changes to comply. All listed medicine sponsors should be taking steps to review and update their listings in accordance with the new framework to ensure a smooth transition process.
A new regulatory framework for complementary medicines was implemented in 2018, to take full effect in 2021. The new framework relies on the classification of all complementary medicines into 3 categories: listed medicines, assessed listed medicines and registered medicines.
The classification of a medicine depends on both its ingredients and indication(s) i.e. the intended therapeutic purpose.
In particular, under the new framework:
- ‘listed medicines’ and ‘assessed listed medicines’ must only contain ingredients which are included in the current Therapeutic Goods (Permissible Ingredients) Determination (currently No. 4 2018) (Permitted Ingredients Determination) and comply with any requirements associated with the use of those ingredients; and
- ‘listed medicines’ must only have indications which are included in the current Therapeutic Goods (Permissible Indications) Determination (currently No.1 of 2018) (Permitted Indications Determination) and comply with any requirements associated with the use of those indications.
Any medicine, including a complementary medicine, which contains ingredients which are not included in the Permitted Ingredients Determination, must be registered in the Australian Register of Therapeutic Goods (ARTG) in order to be commercially supplied in Australia.
However, a medicine which only contains ingredients which are listed in the Permitted Ingredients Determination may be entered in the ARTG as either a ‘listed medicine’ or ‘assessed listed medicine’.
In this regard, how many existing listed medicines will continue to be regulated under the new framework as listed medicines will turn heavily on whether the indications (and claims) made in relation to those products continue to comply with the regulatory requirements for listed medicines under the new regulatory framework.
Comparing assessed listed medicines and listed medicines
To be regulated as a ‘listed medicine’ the indications and claims which may be used are substantially more limited, whereas the assessment pathway for ‘assessed listed medicines’ affords the sponsor some scope to be more inventive with the indications they propose to use.
A ‘listed medicine’ under the new regulatory framework can be listed in the ARTG without undergoing pre-market assessment by the TGA, whereas all of the sponsor’s efficacy evidence supporting a product’s proposed indications must be submitted to and assessed by the TGA before a product can be listed as an ‘assessed listed medicine’ in the ARTG.
The obligations of sponsors in respect of the kind, quality and quantity of evidence for listed medicines under the new framework are in almost all respects equivalent to the requirements under the previous/current framework. In comparison, considerably more robust scientific evidence and more technical documentation is required in order to support an application for listing of an ‘assessed listed medicine’ in the ARTG.
Relevantly, sponsors who submit an application for a new listing before 6 September 2019 will not be required to pay the application fees – $820 for listed medicines and approximately $1-2000 for assessed listed medicines. Notably however, applications for assessed listed medicines will separately incur an evaluation fee, which will not be waived, which is likely to be in the order of $14,000 for most sponsors.
In our view, the ‘assessed listed medicines’ pathway appears to be targeted at complementary medicines which are intended to relieve or prevent particular diseases or injuries and, in turn, have an increased risk profile which warrants the production and assessment of more substantial scientific and clinical evidence that those products will perform as described.
To the contrary, medicines which are intended to assist members of the public to maintain and support their general health and wellbeing are more likely to be suitable for the new ‘listed medicines’ pathway.
The price range, target audience and intended purpose of a medicine may also be relevant to characterising the risk profile of a medicine and, in turn, the more appropriate regulatory pathway.
Notwithstanding the risk profile of a product, sponsors may elect to take the ‘assessed listed medicines’ pathway simply so that they can use, or continue to use, particularly unique or specific indications in respect of their products.
An online tool is available on the TGA website which is intended to assist sponsors to determine which category is most suitable for their product(s) – see here.
Transitioning to the new regulatory framework
There is a 3 year transition period for sponsors of existing listed medicines to re-list their products, most likely either as ‘new’ listed medicines (using permitted indications) or as ‘assessed listed medicines’.
As of 6 March 2021, all complementary medicines which do not comply with the new framework will be cancelled from the ARTG.
We encourage all listed medicine sponsors to review their product formulations and indications, as well as other claims made in relation to their products on the labelling and other promotional materials, and plan to transition their products to the new regulatory framework.
However any sponsor is inclined to proceed, we can assist to ensure that the evidence requirements under the new regulatory framework are satisfied, and provide advice around any changes that may be required to product labelling and other promotional materials.
Get the latest news insights and articles straight to your inbox, simply enter your details.