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Complementary medicines - compliance reviews 2013
Behind the news
This TGA behind-the-news article was published on 4 April 2014. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.
More than 1600 new complementary medicines are listed each year. The TGA does not review these products before listing, because they are considered to be of relatively low risk to consumers and so we cannot guarantee they work - they may only contain pre-approved low-risk ingredients and must not make claims or imply that they have benefit for the treatment or prevention of a serious illness.
Instead, we follow a risk management approach to set priorities and direct resources to those reviews that provide the greatest overall benefit for the Australian public, including the thorough evaluation of all prescription medicines. This approach enables the Australian community to have timely access to these products.
Prioritisation is based upon the potential level of risk to public health and safety. We pay the most attention to:
- the evidence that a sponsor holds to support the indications
- the presentation of the medicine
- the advertising of the medicine.
Compliance reviews conducted September 2012 to December 2013
In September 2012, the TGA implemented a new framework for conducting compliance reviews for listed complementary medicines. Under this framework we perform comprehensive reviews of the evidence held by sponsors.
Each year we review a proportion of listed complementary medicines to check for compliance with regulatory requirements. We may undertake such a review at any time after the product is listed in the Australian Register of Therapeutic Goods (ARTG). During the review, we ask to see any information the sponsor has to verify the certifications they have made. If that certification is incorrect, then we consider taking regulatory action.
We vary the proportion of random and targeted reviews to ensure efficient use of resources and that the risk benefit approach is maintained. This strategy reflects compliance priorities, with an emphasis on high risk cases. Our aim is to increase compliance through education and these review activities.
The issues found in the compliance reviews conducted of listed complementary medicines in 2013 are shown in the table below.
|Incomplete or inappropriate information on the Australian Register of Therapeutic Goods (ARTG)||7|
|Issues with the formulation, manufacturing or quality||8|
|Labelling or advertising||71|
|Inadequate evidence to substantiate claims||21|
|Other (e.g. sponsor has failed to comply with a condition of listing that the medicine is subject to)||14|
|Total number of completed reviews||145|
Note: Medicines may have multiple issues
Once we have identified issues with a product, the sponsor always has an opportunity to make changes to the product to bring it into compliance, and to put their point of view: this opportunity for natural justice is legislated in the Therapeutic Goods Act 1989.
If a product is cancelled, it may be relisted once the compliance issues have been addressed, such as changes to what the product is claimed to be useful for, so that the evidence available supports the indications.
Cancellations following reviews
From September 2012 to December 2013, a total of 249 reviews of listed complementary medicines were undertaken, with 145 of these in 2013 and 104 in the latter part of 2012. Of these reviews, which were both targeted and random, 31% had no breaches of regulatory requirements.
It is difficult to compare with data prior to 2012 because of differences in data collection and in the listing compliance framework.
|Proportion of listed complementary medicine reviews that were randomly selected||18%||14%|
|Notices under Section 30 of the Therapeutic Goods Act (proposals to cancel) sent by TGA to product sponsor||22 notices||62 notices|
|Products cancelled by the TGA||5 products||17 products|
|Products cancelled by sponsor in response to receiving Proposal to Cancel notice||26 products*||16 products|
*The number of cancellations is higher than the number of notices because the notices sometimes alert a sponsor to similar issues with similar products.
From our interaction with listed medicine sponsors, we discovered that it was unclear what we expect to see when we look at evidence. To help with this, we recently published an updated set of guidelines: 'Guidelines on the evidence required to support indications for listed complementary medicines'.
Apart from our reviews, we also receive complaints about advertisements for therapeutic goods, some of which are complementary medicines. The table below shows how we have dealt with the advertising complaints that have been referred to us.
|Description||1 November 2010 to 31 March 2014|
|Recommendations to the TGA from the Complaints Resolution Panel about advertising||129|
|Satisfactory compliance without any order being made||78|
|Regulation 9 orders requiring compliance||30|
*9 received in 2014
** advertising outside the jurisdiction of the TGA (e.g. overseas owned websites, products that are not therapeutic goods); advertisers who have ceased trading; no breach of advertising legislation was found.
More information on TGA regulatory compliance activities is available on this website.
|||Presentation in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods.|