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Listed complementary medicine compliance reviews

9 October 2012

From September 2012, the TGA will use the framework set out below for conducting compliance reviews for listed complementary medicines.

From early 2013, the TGA will publish outcomes of compliance reviews of listed complementary medicines.

Listed medicines

Listed medicines are low risk medicines and are included on the Australian Register of Therapeutic Goods (ARTG) via a streamlined electronic application and validation process (ELF). To be listed on the ARTG a product:

• can only contain low risk ingredients in acceptable amounts that are permitted for use in listed medicines by the Therapeutic Goods Administration (TGA);
• must be manufactured in accordance with the principles of Good Manufacturing Practice (GMP); and
• can carry indications (i.e. claims about the therapeutic use of the product) only for health maintenance and health enhancement or certain indications for non-serious, self-limiting conditions.

At the time of submitting a listed medicine application to the TGA, the sponsor must certify that the goods that are the subject of the application meet all of the requirements of section 26A of the Therapeutic Goods Act 1989 (the Act).

The process for listing products under the Act allows for early market access for low risk complementary medicines. A proportion of listed complementary medicines are reviewed by the TGA following their listing for compliance with the regulatory requirements. This approach enables the Australian community to have timely access to these products, and provides for a consistent basis on which compliance reviews of complementary medicines can be undertaken. More information on the TGA's approach to managing compliance risk is at: TGA regulatory framework.

The compliance review of a listed complementary medicine involves:

• assessing information about the product against the relevant legislative requirements, including, where relevant, the certifications given by the sponsor at the time the product was listed; and
• taking appropriate actions when a breach of the legislative requirements is identified.

The compliance review of a listed complementary medicine may focus on one or several aspects of the medicine. Based on experience and the potential risk that non-compliance represents to the public, the TGA gives greater attention to the following three areas:

• the evidence that a sponsor holds to support the indications;
• the presentation of the medicine; and
• the advertising of the medicine.

A listed complementary medicine may be subject to a number of compliance reviews while it remains on the ARTG.

Selecting listed complementary medicines for compliance review

On average, approximately 1800 new complementary medicines are listed on the ARTG each year. The TGA cannot review all listed complementary medicines and therefore follows a risk management approach to set priorities and direct resources to those reviews that provide the greatest overall benefit for the Australian public. To assist with this determination the TGA gives priority to issues that:

• may result in immediate or potential health risk to consumers;
• could significantly mislead the Australian public, particularly in a way that could have a health impact;
• are industry wide or are likely to become widespread if the TGA does not take action;
• could lead to a loss of stakeholder confidence in the TGA or in therapeutic goods;
• may attract adverse scrutiny from media or the public;
• are of national or international significance; or
• involve a new or emerging issue.

Depending on the circumstances, priority will also be given to products that have been relisted after a previous TGA-initiated cancellation or at the request of the sponsor after a previous compliance review, or where the risk or the characteristics of the medicine are of concern.

Listed complementary medicines with potential non compliance issues may be brought to the TGA's attention from a number of sources, including the public, media, health care professionals or other external sources, referrals from within the TGA, information from other regulatory agencies, screening of the ARTG for recently listed medicines and information from previous compliance reviews. A compliance review initiated from one of these sources is referred to as a targeted review.

A proportion of newly listed medicines are randomly selected by computer, based on a mathematical model, for compliance review. Compliance reviews initiated from this source are referred to as random reviews.

Risk profiling

The TGA intends to strengthen its post market review activities by using the knowledge gained from reviews to inform a more targeted and risk-based approach to monitoring non-compliance in listed complementary medicines. Risk profiles will be developed against the most significant characteristics of these medicines and less compliant sponsors. These profiles will inform the TGA's listed complementary medicine compliance review strategy and enable the TGA to direct resources towards improving regulatory compliance on a risk basis.

Initiating a listing compliance review

Random review

If a recently listed medicine randomly selected at the time of listing is chosen for a compliance review, the following information will usually be requested from the sponsor under the provisions of section 31(2) of the Act:

• actual label(s) used for the product as it is supplied in Australia;
• finished product specifications;
• a certificate of analysis for the last released batch (i.e. a statement about results of testing of the product and how they compare with established acceptance criteria);
• Manufacturing formula including a list of all ingredients and their quantities in the product;
• a summary of the evidence held by the sponsor that supports the indications and claims made in relation to the product (detailed evidence may be requested during the review, if required); and
• copies of completed TSE (Transmissible Spongiform Encephalopathy) questionnaire/s and supporting data, if applicable to ingredients.

The TGA may also view websites for the purpose of considering whether advertising for the product complies with the Therapeutic Goods Advertising Code.

Targeted Review

If a listed complementary medicine with potential-non compliance issues is chosen for a targeted review, the review may be conducted upon information provided in a complaint or referral (if appropriate), information from other sources and/or information included on the ARTG. A request for information by notice under section 31(2) of the Act may also be required. The type of information requested can be diverse and may include (but is not limited to) the information that can be sought for the purposes of a random review (as outlined above) and:

• raw material specifications and certificates of analysis;
• methodology and results in relation to a specific test;
• copies of permits and/or licences 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; and
• detailed evidence to support the indications and claims made in relation to the product.

Sponsor cancellation

A sponsor can request that the TGA cancel its product from the ARTG at any time. If the medicine is relisted a subsequent review may, depending on the circumstances in which the product was cancelled, be undertaken according to the prioritisation strategy described above.

Review findings and review outcomes

During a compliance review, the available information for a listed complementary medicine is assessed against the relevant legislative requirements, including the Act, the Therapeutic Goods Regulations 1990, the Therapeutic Goods Advertising Code, relevant Therapeutic Goods Orders, conditions of listing and other relevant/applicable legislative documents.

Additional information may be requested under section 31(2) of the Act in order to determine the medicine's compliance status.

No compliance issue found

Where no breach of the relevant legislative requirements is found, the review will be finalised. The medicine will remain on the ARTG.

Compliance issue(s) found

Where a breach of a legislative requirement is identified, there are a range of regulatory actions available to the TGA which can include the issuing of a notice under section 30 of the Act to cancel or proposal to cancel the product from the ARTG.

Where relevant and applicable, the listing of the product can be cancelled by the Secretary under subsections 30(1), 30(1A) or 30(1C) of the Act without a proposal to cancel notice being issued. These circumstances include (but not limited to):

• where it appears to the Secretary that failure to cancel the listing would create an imminent risk of death, serious illness or serious injury;
• the product is not 'eligible for listing', for instance, because it contains ingredients other than those allowed under the legislation to be used for listed complementary medicines;
• where manufacture of the goods in Australia has not been undertaken by a person who holds a manufacturing licence under the Act;
• the product contains substances that are prohibited imports under the Customs Act 1901; or
• the sponsor is given a notice by the TGA requiring it to provide information or documents for the purposes of determining whether the product should have been listed and the sponsor has not complied within 20 working days after the notice was given.

If a proposal to cancel notice is issued under subsection 30(3) of the Act, the sponsor must be given a reasonable opportunity to provide a submission to the TGA to address the non compliance issues raised. Depending on the situation the following outcomes may result:

• the sponsor's submission satisfactorily addresses all non compliance issue(s) raised. The review is finalised and the medicine remains on the ARTG; or
• the sponsor makes a request to the TGA to cancel the goods from the ARTG. The medicine is cancelled from the ARTG under s30(1)(c) of Act and the review is finalised; or
• the submission does not satisfactorily address all non compliance issue(s) raised. The medicine is cancelled from the ARTG by a delegate of the Secretary and the review is finalised.

During any stage of the listing compliance review, a product undergoing a compliance review can be cancelled from the ARTG at the request of the sponsor without the compliance review being completed. In this situation, the review will be terminated when the product is cancelled from the ARTG.

Other outcomes

In some circumstances the TGA will consider other regulatory options following a compliance review including:

• suspension of the listing of a non-compliant product from the ARTG under section 29D of the Act;
• whether a non compliant product that is currently supplied on the Australian market should be recovered, i.e. recalled from the market place;
• whether additional conditions of listing should be imposed in relation to the product.

These are assessed case by case.

Following cancellation

Under the Act:

• it is an offence for the "sponsor" of therapeutic goods to import, supply or manufacture in Australia therapeutic goods that are not on the ARTG or are not otherwise exempt from being included in the ARTG (s.19B).
• as an alternative to criminal prosecution as outlined above, civil penalties are payable by the "sponsor" of therapeutic goods for importing, supplying or manufacturing therapeutic goods that are not on the ARTG or are not otherwise exempt from being included in the ARTG (s.19D). "Sponsor" here means the person who imported or arranged the importation of the goods or manufactured or arranged the manufacture of the goods in Australia. "Supply" has a very broad meaning and includes supply by way of sale, exchange, gift, sample or advertisement and by way of administration to, or application in the treatment of, a person.

It is also an offence under the Act for a person:

• who is not the "sponsor" (i.e. the importer or manufacturer as described above) to supply to another person (who is not the ultimate consumer) if the goods are not on the ARTG or otherwise exempt from being included in the ARTG (s.21); and
• to publish or broadcast an advertisement about therapeutic goods that are not on the ARTG (s.42DL(1)(g)) or to publish an advertisement in a newspaper or magazine or broadcast on radio or on free-to-air television that has not been approved by the Secretary where such an approval is required (s.42C).

It may also be an offence under the law of some States to supply therapeutic goods that are not included in the ARTG.

Review of TGA decisions

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 (under subsection 31(2) of the Act);
• a decision to impose additional conditions of listing (under section 28 of the Act);
• a decision to suspend a product from the ARTG (under section 29D of the Act) or to cancel a product from the ARTG (under section 30 of the Act); and
• a decision recover (recall) a product (under section 30(EA) of the Act).

Any person "whose interests are affected" by such a decision can ask for an internal review conducted by a delegate of the Minister/Parliamentary Secretary and then Administrative Appeals Tribunal review of that decision. For more information please refer to section 14, Part IV of the Australian Regulatory Guidelines for Complementary Medicines.

Publication of compliance activities and review outcomes

The TGA will publish information on compliance activities and review outcomes in the following manner:

1. information on the TGA website where a listed complementary medicine is cancelled from the ARTG following a compliance review;
2. regular consolidated compliance review outcomes for a defined period including name of the product, ARTG number, sponsor name and the outcome of the relevant compliance review; and
3. statistics on compliance review activity undertaken by the TGA including number of reviews, number of reviews in progress and information on the outcomes of reviews.

Contact

For further information about the framework, contact the Office of Complementary Medicines.

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