Complementary medicines - compliance reviews outcomes 2014

31 March 2015

Each year we review a proportion of listed complementary medicines to check for compliance with regulatory requirements. Since September 2012 we have published cancellations arising as an outcome of these reviews.

We may undertake a review at any time after a medicine is listed on the Australian Register of Therapeutic Goods (ARTG) and we vary the proportion of random and targeted reviews to ensure efficient use of resources and maintain a risk benefit approach. For more information on our compliance review framework, see Listed complementary medicine compliance reviews.

From January 2014 to December 2014, 190 new compliance reviews and other investigations of listed medicines were initiated and 300 reviews/investigations were finalised, as shown in the following table.

Table: Number of listed medicine compliance reviews/investigations conducted in January to December 2014
Initiated compliance reviews/investigations Finalised* compliance reviews/investigations
Random reviews 35 41
Targeted reviews 68 181
Other investigations# 87 78
Total 190 initiated reviews/investigations

222 finalised compliance reviews

78 finalised other investigations

TOTAL = 300 finalised reviews/investigations

* Finalised reviews/investigations include reviews/investigations initiated prior to January 2014.

# Investigations can include products not listed on the ARTG. All investigations are assessed and triaged based on risk to provide the greatest overall benefit for the Australian public. Investigations may be finalised through a number of mechanisms, such as initiating a targeted review or referral.

Outcomes of finalised reviews in 2014

222 listed medicine compliance reviews were finalised between January and December 2014, of these:

  • 41 were random reviews, 181 were targeted reviews.
  • Compliance status was determined for 164 medicines for the selected listing requirements being reviewed.
  • Compliance status was unable to be determined for 58 medicines, for reasons such as: the medicine was cancelled by the sponsor; the medicine was cancelled due to non-payment of fees; or the medicine was not yet manufactured.

The table below shows the outcome of random and targeted reviews of listed complementary medicines in 2014.

Table: Outcome of listed medicine compliance reviews in January to December 2014
No compliance breaches identified for the selected listing requirements Compliance breaches identified for the selected listing requirements Compliance status unable to be determined (see above for explanation)
Targeted reviews
Total: 181
26 14% of targeted reviews 110 61% of targeted reviews 45 25% of targeted reviews
Random reviews
Total: 41
17 41% of random reviews 11 27% of random reviews 13 32% of random reviews

The higher rate of non-compliance in targeted reviews reflects that these reviews were initiated due to a potential issue of non-compliance being identified.

Types of compliance breaches in 2014

The issues found in compliance reviews of listed complementary medicines in 2014 are shown in the table below. Note that a medicine may have had multiple issues.

Table: Types of compliance breaches in January to December 2014
Compliance breach Occurrence Percentage
Information provided in ARTG entry 7 4%
Product: formulation/manufacturing/quality 14 7%
Labelling and advertising 83 44%
Evidence to support indications 39 21%
Other breaches, such as: the sponsor failed to comply with a condition that the medicine is subject to; or the sponsor failed to comply with an additional condition of listing. 46 24%
TOTAL 189 100%

Actions taken following compliance reviews

Under the Therapeutic Goods Act 1989 a sponsor must be given the opportunity to respond to issues raised during a compliance review. Sponsors may make changes to bring their product to compliance and prevent them being cancelled from the Australian Register of Therapeutic Goods (ARTG). For information on how we proceed following a compliance review, see Possible outcomes of a compliance review.

The following table lists the actions taken after initiation of listing compliance reviews in 2014.

Table: Actions taken for listed medicine compliance reviews in January to December 2014
Actions taken for listed medicine compliance reviews Number of medicines
Compliance reviews initiated but not able to be completed, for reasons such as: medicine not yet manufactured or product cancelled for non - payment of fees. 23
TGA cancelled medicine at sponsor request before compliance status could be determined, for example: after receiving a letter from the TGA initiating the review. 36
Investigations resulting in the initiation of targeted review. 43
'Proposal to cancel' letter sent by the TGA. 114
TGA cancelled medicine at sponsor request after receiving 'Proposal to cancel' letter. 36
Medicine cancelled by the TGAx. 51

x For details on products that were cancelled from the ARTG by the TGA in 2014, see Complementary medicines: Cancellations from the ARTG 2014.

What is TGA doing to encourage compliance?

Our aim is to increase compliance through education and ongoing communication with sponsors during these review activities.

We have been working with industry to help sponsors understand their regulatory obligations. In 2014 we published the revised 'Guidelines on the evidence required to support indications for listed complementary medicines' and conducted a number of workshops to assist sponsors in the use of these guidelines. We also published a revised Australian regulatory guidelines for complementary medicines (ARGCM) to raise awareness of the regulatory requirements for complementary medicines.

In 2015, we will continue to improve our guidance and engagement with industry and other stakeholders.