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Listed medicine compliance rating scheme

28 November 2018

The Listed Medicine Compliance Rating Scheme commenced on 28 November 2018 as part of our existing compliance review process. Following a transition period of six months, we will begin to publish the ratings assigned to individual medicines under the Scheme as part of publishing the overall outcomes of each review on the TGA website.

We have implemented a Compliance Rating Scheme for listed medicines as part of ongoing enhancements to our post-market compliance monitoring program. It standardises how we rate listed medicines we have reviewed in terms of any non-compliance with regulatory requirements and the associated risks to consumers. The scheme provides predictability for sponsors about our approach to compliance and will underpin increased transparency for consumers about the safety and efficacy of self-selected medicines on the market.

Background

As listed medicines are not evaluated by the TGA before they are included on the Australian Register of Therapeutic Goods (ARTG), we conduct post-market compliance reviews on a proportion of those on the ARTG each year to ensure their ongoing safety, quality and efficacy.

In response to the Medicines and Medical Devices Regulation (MMDR) review, the Government accepted a recommendation to develop a more comprehensive post-market monitoring scheme for listed medicines, including that we should make information publically available on individual listed medicines that had been subject to any review, as well as the timing and outcome of the review.

To support the publication of review outcomes on the TGA website, we have developed a Listed Medicine Compliance Rating Scheme (the Scheme) in consultation with peak industry and consumer representative bodies. The Scheme is intended to aid consumers in interpreting the outcomes of compliance reviews once we begin to publish the outcomes on our website. This will enable them to make informed choices about their use of self-selected medicines and provide an incentive for sponsors to improve overall compliance of their products.

What does it involve?

Under the Compliance Rating Scheme, we assign a rating from 'A' to 'F' to each listed medicine we have reviewed, based on the deficiencies in meeting regulatory requirements that we identified during the review. The rating conveys a medicine's regulatory compliance status at the time we reviewed it and the implications of any non-compliance for consumers. Full details of the Scheme are provided on the compliance reviews web page.

What has changed and how does it work?

The Scheme has been incorporated into our compliance review process and sponsors of listed medicines that we review will now encounter it in operation as part of this process. The key changes are:

  • We now calculate a Compliance Review Rating for each medicine we review based on the deficiencies we have identified.
  • When we notify the sponsor of any deficiencies identified, we now also notify them of the corresponding rating for their medicine.
  • When we take into account the sponsor's response to our findings in reaching a final decision about the compliance of their medicine and any necessary regulatory actions we now also confirm the Compliance Review Rating of their medicine.
  • The Compliance Review Rating now appears in our correspondence to the sponsor about the outcome of the review of their medicine.

The Scheme does not change our risk-based approach to regulation. Instead it provides greater transparency and predictability for sponsors as to how we stratify non-compliance according to the risk posed to consumers. As is the case in the vast majority of compliance reviews, where the risk posed by the compliance issue allows, we will still afford sponsors procedural fairness and give them an opportunity to bring their medicine into compliance.

It is important to note that the Compliance Rating of a medicine reflects the status of the medicine at the time of the review, i.e. before the sponsor takes action, if necessary to bring their medicine into compliance.

Implementation arrangements

During the six month transition period, we will notify sponsors of the Compliance Review Ratings for their medicines reviewed by us during this time but the individual ratings will not be published and there will be no change to the current arrangements for publishing review outcomes on the TGA website.

We will undertake refinements to the Scheme during the transition period based on feedback from our stakeholders.

Next step: Publication of Compliance Review Rating as part of the review outcomes

After the transition period, we will commence publishing the outcomes of all compliance reviews, including Compliance Review Ratings assigned to individual medicines, in a searchable database on the TGA website. At this point, review outcomes will be publicly available and consumers will be able to observe the Scheme in operation in relation to individual medicines of interest to them.

We are currently developing a suite of information aimed at consumers to support their understanding of the Scheme and use of the database once it launches.

Full details about the publication of all review outcomes for sponsors and consumers will be published on the TGA website at the conclusion of the transition period and before publication commences.

Frequently asked questions

Does an 'A' Compliance Review Rating mean the medicine is endorsed by the TGA or meets all regulatory requirements?

No. The TGA does not endorse or approve the use of listed medicines. As part of a compliance review, we assess only selected listing requirements and therefore cannot assure all regulatory requirements are met at all times – this is the responsibility of the sponsor.

Can sponsors use an 'A' Compliance Review Rating for advertising purposes?

No. The TGA does not endorse or approve the use of listed medicines that have been assigned an 'A' or any other rating. Any reference in a medicine's advertising to the Compliance Review Rating from TGA may imply endorsement from a government agency which is a breach of the Therapeutic Goods Advertising Code.

What can a sponsor do if they disagree with the Compliance Review Rating assigned to their medicine?

During the compliance review process, we notify sponsors of any identified compliance deficiencies. This now includes the Compliance Review Rating of their medicine. The sponsor may respond to us with a submission about the compliance deficiencies or justification for why their medicine is in fact not deficient in meeting particular or all requirements, before we make a final decision. The Compliance Review Rating will be confirmed after consideration of this submission. If applicable, the sponsor must then take action to bring their medicine into compliance to allow it to remain on the ARTG.

When will information about individual medicines that have been reviewed, including their Compliance Review Ratings, be made publicly available on the TGA website?

The outcomes of compliance reviews that are initiated following the completion of the six-month transition period will be published on the TGA website. We anticipate this will commence in late 2019. Outcomes of a compliance review will include the Compliance Review Rating of the medicine at the time of the review, summary of issues identified and actions taken by the sponsor, if necessary to bring their medicine into compliance with the regulatory requirements to remain on the ARTG.

Contact

For further information, please contact Complementary Medicines and OTC Medicines Branch via phone on 1800 020 653 or via email at complementary.medicines@health.gov.au.