Efficacy of Lysine Hydrochloride containing medicines for cold sores

The TGA will be initiating targeted compliance reviews of selected listed medicines to evaluate evidence held to support indications related to cold sores.

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.

We will be conducting compliance reviews of selected listed medicines to evaluate their efficacy. We will focus on listed medicines with indications related to management of cold sores, particularly those containing Lysine Hydrochloride. This includes:

• Decrease/reduce/relieve burning/tingling associated with facial cold sores
• Decrease/reduce/relieve symptoms of facial cold sores
• Enhance/improve/promote healing of facial cold sores
• Helps reduce occurrence of facial cold sores

I am a sponsor, what should I do?

If you are a sponsor of a listed medicine which utilises an indication relating to the management of cold sores, you are encouraged to:

• review the evidence that you hold with respect to cold sore related indications 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 cold sore indications as specified by the Therapeutic Goods (Permissible Indications) Determination.

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 cold sore related indications 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 particular focus on the evidence supporting the cold-sore related indications.

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.