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Listed medicine compliance reviews
Listed medicines are included in the Australian Register of Therapeutic Goods (ARTG) without undergoing a full pre-market evaluation by the TGA. Sponsors of listed medicines must certify that their medicines meet all the requirements of 26A of the Therapeutic Goods Act 1989, and ensure they satisfy certain criteria for low-risk medicines.
The TGA conducts post-market compliance reviews of selected listed medicines on the ARTG to determine whether these medicines comply with relevant regulatory requirements. During review, if a medicine is found to not comply with requirements, action is taken by the TGA according to the risk posed by the medicine to the consumer. For example, the TGA may require the sponsor to updates the medicine's label, remove it from the ARTG so that it can no longer be lawfully supplied to the consumer, or recall the medicine from the market.
Refer to Overview of listed medicines and registered complementary medicines for information on the regulatory framework for listed medicines.
How the TGA selects medicines for a compliance review
There are approximately 12,000 medicines listed on the ARTG at any one time and over 1000 are newly listed each year. Given the low-risk nature of listed medicines, the TGA selects only some of those in the ARTG for review each year. Listed medicines may be subject to any number of compliance reviews while they remain in the ARTG.
The TGA may select listed medicines with suspected or potential issues in meeting regulatory requirements for targeted review according to a risk-based approach. Priority is given to issues that:
- may result in an immediate or potential health risk to consumers
- could significantly mislead the Australian public, particularly where there is a health impact
- involve a new or emerging issue of concern
- are likely to become widespread if we do not intervene
- are the subject of public or media scrutiny and concern
- are of national or international significance
- could lead to a loss of stakeholder confidence in the Government's regulatory scheme or in therapeutic goods.
Priority may also be given to medicines that:
- are a 'relisting' of a medicine that was recently cancelled from the ARTG (by either the sponsor or the TGA)
- belong to a sponsor with a history, based on past compliance reviews, of their medicines being non-compliant
- a particular type of product (e.g. medicines with particular ingredients or indications) for which there are concerns of non-compliance.
We use information from a variety of sources to select medicines for targeted review that include, but are not limited to:
- reports from the public, media, healthcare professionals or other external sources
- information from other regulators
- screening the ARTG for recently listed medicines
- information from previous compliance reviews, such as medicine characteristics, the nature of the compliance deficiencies identified and the identities of the sponsors
- complaints or referrals, if appropriate.
The TGA also randomly selects a proportion of listed medicines for review using a computer algorithm. Random reviews serve several purposes:
- Identifying compliance issues that may be the focus of future targeted reviews
- Profiling medicines and sponsors that are not compliant
- Encouraging sponsors to ensure the ongoing compliance of their medicines
The compliance review process
The review process comprises several stages, which are outlined in the Compliance Review Process poster (pdf,128kb).
We conduct compliance reviews of listed medicines that are on the market to check whether they meet regulatory requirements. The typical steps in the review process are:
- For example, a proposal to cancel notice.
- Such as a recommendation for recall, issuing of infringement notice(s), etc.
- Regulatory actions that are available to the TGA to address non-compliance.
The key messages for sponsors about the process:
- When a review of a medicine is initiated, the sponsor will receive a notice from the TGA by email which includes a request for relevant information about their medicine, and specific details about the review. If the sponsor does not respond to the request for information or provides false or misleading information, the TGA may take regulatory action, which can include cancellation of the medicine from the ARTG.
- During review, the information provided by the sponsor (e.g. label, manufacturing documentation, efficacy evidence) is assessed to determine whether there are any breaches of relevant regulatory requirements. Websites or other advertising materials relating to the medicine may also be assessed.
- Where regulatory requirements have been breached, sponsors are notified of the issues that have been identified, and consistent with procedural fairness, a right of response is granted. Where circumstances allow, the TGA provides sponsors with the opportunity to rectify compliance issues that have been identified to bring their product into compliance and allow the medicine to remain on the ARTG.
- After considering the sponsor's response, if one was provided, sponsors are then notified of the final decision about their listed medicine. At this time, sponsors are notified of the review outcomes and what information about the review will be published in the Database of TGA listed medicine compliance review results.
- After taking into account the sponsor's submissions about the proposed publication information, if one was provided, the results of the compliance review will be published. Details of medicines that are cancelled from the ARTG are also published on the TGA's database of cancellations from the ARTG.
Information the TGA may request in a compliance review
The TGA does not necessarily review the compliance of a medicine with all listing requirements. According to our risk-based approach, we may assess compliance with either a broad range or a narrow set of specific listing requirements. The scope is determined based on information that the TGA possesses about the medicine or the sponsor.
Depending on the scope of the review, one or more of the following is usually requested from the sponsor under the provisions of section 31(2) of the Act:
- labels and supply status for the medicine
- links to pages where the medicine is advertised to Australian consumers
- finished product specifications
- a certificate of analysis for the last released batch
- manufacturing formula including a list of all ingredients and their quantities
- the evidence held by the sponsor that supports the indications and claims made in relation to the medicine
Further information may also be requested such as:
- raw material specifications and certificates of analysis
- methodology and results of a specific test
- copies of permits and/or licenses allowing the importation of the medicine if it contains substances that are prohibited imports for the purposes of the Customs Act 1901
- promotional and advertising material
- amount of stock supplied and who it has been supplied to.
Possible findings during a compliance review
There are three possible findings by the TGA during a compliance review.
(1) The compliance status cannot be determined
The compliance status of a listed medicine cannot be determined if the TGA elects to cease the review because the medicine:
- was cancelled by the sponsor before the review commenced, or
- was cancelled by the TGA due to non-payment of fees by the sponsor, or
- has not been manufactured
The sponsor can request that their medicine be cancelled from the ARTG at any stage of the compliance review. However, if this medicine is subsequently relisted, a targeted review may be undertaken according to our prioritisation strategy.
(2) No compliance issues for the selected listing requirements were identified
The compliance review is closed, the sponsor is notified and the results of the review will be published in the database of TGA listed medicine compliance review results. The medicine remains on the ARTG.
As reviews often cover only selected listing requirements, sponsors must actively ensure ongoing compliance with all relevant requirements of the regulatory framework at all times.
(3) Compliance issues were identified
Where compliance issues are identified, these are provided to sponsors for comment. The TGA will then make a decision on the appropriate regulatory action - refer to Regulatory action for a non-compliant medicine.
Details of deficiencies related to the safety and efficacy of the medicine will be included in the publication.
Regulatory action for non-compliant medicines
If the TGA finds that a listed medicine does not comply with a regulatory requirement, a number of regulatory actions may be pursued, including, but not limited to:
The TGA issues a Proposal to Cancel Notice under subsection 30(3) of the Act
If this occurs, the TGA:
- advises the sponsor of the deficiencies that have been identified
- advises the sponsor of the corresponding deficiency catregories
- provides the sponsor a reasonable opportunity to refute the findings or address the deficiencies with evidence or justification
One of the following outcomes may occur:
- the sponsor satisfactorily addresses all non-compliance issues and the medicine remains on the ARTG
- the sponsor requests that the TGA cancel the medicine from the ARTG
- the TGA may cancel the medicine (under subsection 30(2) of the Act) if the sponsor does not satisfactorily address all non-compliance issues
The medicine is cancelled from the ARTG
Under subsections 30(1), 30(1A) or 30(1C) of the Act, the TGA may cancel the medicine without issuing a Proposal to Cancel Notice, where:
- there is an imminent risk of death, serious illness or serious injury
- the medicine is not 'eligible for listing', for example, it contains ingredients that are not permitted in listed medicines
- the manufacturing of the product in Australia has not been performed by a person with a manufacturing licence
- the medicine contains substances that are prohibited imports under the Customs Act 1901
- the sponsor failed to provide the required information within 20 working days after requested to do so.
The medicine is recalled from the market
A product recall is the removal of the medicine from supply on the Australian market. Recall of any distributed goods is required whenever public safety is at risk as a result of non-compliance. Further information on recalls is provided on our website: About Australian recall actions.
If a medicine is cancelled from the ARTG
If a medicine is cancelled from the ARTG, it can no longer be imported, exported, manufactured or supplied for use in Australia. To do so is an offence under the Act. It can be either a criminal offence (s.19B) or a civil offence (s.19D). It is also an offence to advertise therapeutic goods that are not on the ARTG (s.42DL(1) and s.42DLB(1)).
Review of a TGA decision
Some decisions made by the TGA during a compliance review of a listed medicine can be reviewed. These include a decision to:
- request information or documents (subsection 31(2) of the Act)
- impose additional conditions of listing (section 28 of the Act)
- suspend a product from the ARTG (section 29D of the Act)
- cancel a product from the ARTG (section 30 of the Act)
- recover (recall) a product (section 30(EA) of the Act).
Any person whose interests are affected by such a decision can ask for an internal review by a delegate of the Minister/Parliamentary Secretary - refer to Reconsideration of reviewable initial decisions.
Publication of information about compliance activities
The TGA publishes the following information on compliance activities:
- Details of medicines that have been cancelled by the TGA from the ARTG following a compliance review - refer to Complementary medicines: Cancellations from the ARTG.
- Yearly statistics on compliance review activity undertaken, including information about the number and types of reviews and outcomes - refer to the Annual performance statistics reports for more information.
- The outcomes of individual compliance reviews for consumers - refer to Publishing of listed medicine compliance reviews results for more information about the scheme that was implemented in November 2019.
Publication of individual compliance review results
After the conclusion of a compliance review, the TGA makes information about the findings and outcomes of the review publicly available on the TGA website in the Database of listed medicine compliance review results (the Database). These results are published in the Database quarterly.
When a listed medicine compliance review is concluded, the TGA will notify the medicine’s sponsor of the proposed wording for the results of the review that will be used for publication. This wording is determined based on the details set out in the Therapeutic Goods (Listed Medicine Compliance Review) Specification 2019.
Following a compliance review, we will provide an opportunity for sponsors to make a submission to the TGA about the results proposed to be published about their medicine. Information about how to make a submission is provided in a letter from the TGA. The submission will be considered by the TGA prior to publishing the results of the compliance review.
The outcomes of these compliance reviews are then released under subsection 61(5C) of the Act, for the purpose of allowing public access to information (via the Database) on individual listed medicines subject to a review. The release of this information is not eligible for internal review by a delegate of the Minister under section 60 of the Act as it does not constitute an initial decision.
For further information contact the Complementary and OTC Medicines Branch.