The TGA will be initiating targeted compliance reviews of selected listed medicines to evaluate evidence held to support indications related to exercise performance.
If you are a consumer, please note that this is part of our normal review process and there is no immediate concern associated with the use of these types of listed medicines.
Background
Listed medicines may be subject to a compliance review at any time while they remain on the Australian Register of Therapeutic Goods (ARTG). This allows us to determine the compliance of these medicines with relevant regulatory requirements.
Listed medicines are only permitted to use low risk indications from a pre-approved list. Sponsors of listed medicines are required to certify that they hold evidence to support their medicine’s indications.
The Australian Institute of Sport released a position statement in 2021 to support informed decisions and safe practices around supplement use for enhancing exercise performance. The statement identified certain supplement ingredients that have insufficient scientific evidence to support their efficacy for exercise performance.
As such, we will be conducting compliance reviews of selected listed medicines with indications related to exercise performance, such as physical/exercise/muscle and performance/endurance/capacity/stamina, to evaluate their efficacy.
I am a sponsor, what should I do?
The Therapeutic Goods (Permissible Indications) Determination contains the list of indications allowed by the TGA for use in listed medicines and any specific requirements for each indication. If you are a sponsor of a listed medicine which utilises an indication relating to exercise performance, such as physical/exercise/muscle and performance/endurance/capacity/stamina, you are encouraged to:
- review the evidence that you hold with respect to indications related to exercise performance in accordance with the Evidence Guidelines for listed medicines; and
- re-evaluate the presentation of the goods, including the medicine label and web advertising, particularly for any requirements related to exercise performance indications for your medicine.
If your medicine is selected for review, you will receive a Request for Information notice. This notice will contain an explanation of the review process, outline the information you are required to submit and relevant due dates for your response.
What the TGA will do
The TGA will commence desktop compliance reviews for a selection of listed medicines using indications related to exercise performance in the fourth quarter of 2022. These may either be selected randomly or on the basis of regulatory intelligence.
We will send sponsors of these medicines a Request for Information notice informing them of the commencement of the review and outlining the information sponsors are required to submit. Upon receipt of the information provided by sponsors, we will assess the medicine against listing requirements, with a particular focus on the evidence supporting the indications for exercise performance.
If no compliance deficiencies are identified for a selected medicine, the review will be concluded and there will be no further regulatory action. If deficiencies are identified, the sponsor will be given an opportunity to address the deficiencies. Additionally, enforcement actions (such as the cancellation of the medicine from the ARTG, issuing of infringement notices, etc) may be taken.
Should sponsors cancel their listing rather than respond to the Request for Information notice, we may still request certain documentation to be provided to ensure that certifications made at the time of listing were correct.
A summary of the outcomes from this compliance activity will be published after the conclusion of the reviews.