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Listed medicine compliance reviews

27 November 2019

Listed medicines are included in the Australian Register of Therapeutic Goods (ARTG) without undergoing a full pre-market evaluation by the TGA. This relies on the medicine satisfying certain criteria for low risk medicines and certification by the sponsor that their medicine meets all of the requirements of section 26A of the Therapeutic Goods Act 1989.

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 that the sponsor updates the medicine's label, or the TGA may remove it from the ARTG so that it can no longer be lawfully supplied to the consumer.

Refer to Overview of listed 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.

Targeted reviews

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.

Random reviews

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

How to access a pdf document

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:

Review stage Actions
Initiation
  1. We send a Request for information notice to the sponsor requesting selected information about the medicine.
  2. The sponsor supplies the requested information to us by the due date. If the sponsor does not provide an adequate response, we may cancel the medicine under section 30 of the Act.
Review
  1. We assess the information provided against relevant legislation; this assessment may be broad or focused on a limited set of selected legislated requirements.
  2. If we do not find any compliance deficiencies based on the information provided at that time, the TGA will go to the Decision Stage. No further action is taken.
  3. If we identify medicine compliance deficiencies, we send a Proposal to Cancel notice to the sponsor notifying them of the deficiencies.
Response
  1. The sponsor considers the deficiencies identified in our Proposal to Cancel notice and may make a submission to us with evidence or justification that the compliance deficiencies we identified are invalid. The sponsor may also respond to any questions we have about the deficiencies identified. They may also include actions they have already taken in the interim to remedy the compliance deficiencies.
  2. We consider the sponsor's submission. If no submission is provided, there is no additional information to consider and the medicine remains non‑compliant.
Decision
  1. We make a final decision about the deficiencies of the medicine as at the time of the review. We notify the sponsor of our final decision, and any regulatory action, in our final letter to them. We will also provide a copy of the information outlining the results of the review that will be published on the TGA website.
  2. Under certain circumstances, we may provide additional time for the sponsor to rectify the deficiencies identified to bring their medicine into compliance and allow it to remain on the ARTG.
  3. If, after consideration of the sponsor's submission, we are not satisfied that the deficiencies were adequately addressed, or the sponsor did not make a submission, the medicine is considered to be non‑compliant and we cancel the medicine from the ARTG.
  4. The sponsor can request for our decision to be reconsidered under section 60 of the Act if they do not agree with it. This must be done within 90 days of the decision being made.
Publication
  1. We currently publish details of medicines that are cancelled from the ARTG on the TGA website. From December 2019 we will publish the outcome of each individual compliance review on the TGA website.
  2. The outcomes of compliance reviews are also included in the TGA Annual Performance Statistics Report.

For more resources and further information go to: Australian regulatory guidelines for complementary medicines (ARGCM) or email: Complementary.Medicines@health.gov.au.

The key messages to sponsors about the process are:

  • When a review of a medicine is initiated, the sponsor will receive a notice from the TGA by email which includes specific details about the review. Where there is no significant safety concern about the medicine, the TGA requests that the sponsor provides relevant information about their medicine for assessment by the response due date. If the sponsor does not respond to the request for information or provides false or misleading information, the TGA may take further regulatory action, which can include cancellation of the medicine from the ARTG.
  • During review, the information provided by the sponsor is assessed to determine whether there are any breaches of the relevant regulatory requirements, including those in the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, Therapeutic Goods Orders, conditions of listing and other applicable legislative documents. Websites relating to the medicine or other advertising material may also be assessed to consider whether advertising for the medicine complies with the Therapeutic Goods Advertising Code.
  • In determining whether regulatory requirements have been breached and what, if any, regulatory action to take, 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 taking into account the sponsor's response, if one was provided, sponsors are then notified of the final decision at the conclusion of the compliance review. At this time, sponsors are notified of the review outcomes and what information about the review 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 possess 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 for the medicine as it is supplied in Australia
  • 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
  • if applicable, information relating to Transmissible Spongiform Encephalopathy.

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.

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 medicines cannot be determined if the medicine:

  • was cancelled by the sponsor before assessment commenced, or
  • was cancelled by us 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.

If the TGA is unable to determine the compliance status of a medicine due to one of the above scenarios, the review is closed without further action.

(2) No compliance issues for the selected listing requirements were identified

The compliance review is closed, the sponsor is notified and the results 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 categorised according to the level of deficiency. The TGA takes appropriate regulatory action - refer to Regulatory action for a non-compliant medicine.

The 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 there are a number of regulatory actions that can 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 place

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 Mechanism for review of decisions made under the Act.

Publication of information about compliance activities

The TGA publishes the following information on compliance activities:

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. These results will be published in the database quarterly.

When a listed medicine compliance review is concluded, the TGA will notify the medicine sponsor of the proposed wording about 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.

Sponsors of listed medicines that are reviewed will have an opportunity to make a submission to the TGA about the results that are 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.

Contact

For further information contact the Complementary and OTC Medicines Branch.