Stability requirements for listed medicines

The TGA will be initiating targeted compliance reviews of selected listed medicines to evaluate compliance with the certifications made by sponsors at the time of listing a medicine on the Australian Register of Therapeutic Goods (ARTG). 

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 listed medicines.

Background

Listed medicines may be subject to a compliance review at any time while they remain on the ARTG. This allows us to determine the compliance of these medicines with relevant regulatory requirements.

Listed medicines are not evaluated by the TGA for safety, quality and efficacy before they are supplied in the marketplace. Instead, sponsors of listed medicines are required to certify that their medicine is safe, of good quality and works as intended. 

In line with the above, sponsors are required to certify that they hold relevant records (such as stability information) to meet quality requirements for their medicine when listing it on the ARTG. 

As such, the TGA will be conducting compliance reviews of selected listed medicines to assess sponsors’ compliance with the certifications made at the time of listing their medicines on the ARTG. 

What sponsors of listed medicines need to do 

If you are a sponsor of a listed medicine, you should ensure that: 

• prior to or at the time of listing, you hold information or evidence to show that your medicine’s specifications will be maintained under the conditions set out on the medicine’s label until the medicine’s expiry date
• you review the data that you hold with respect to the stability of your medicine against relevant requirements. Please refer to Guidelines on quality for listed medicines and/or the Guidelines for the Quality of Listed Probiotic Medicines
• the information or evidence you hold is substantiated by robust scientific justifications – such as when grouped stability data and quantified by input are used; and
• where there is an applicable standard(s), your medicine conforms to that standard(s).

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.

If you decide to cancel the listing of your medicine in response to the Request for Information notice, we may still request certain documentation to be provided to ensure that the certifications made at the time of listing were correct.

What the TGA will do

The TGA will be conducting desktop compliance reviews for a selection of listed medicines, reviewing stability information.

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 certifications made at the time of listing the medicine on the ARTG.

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 where deficiencies have been identified.

A summary of the outcomes from this compliance activity will be published after the conclusion of the reviews.