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TGA medicine labelling and packaging review


24 May 2012

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Regulation of medicines in Australia

The TGA is the Commonwealth Government agency responsible for making decisions about whether to approve a therapeutic good for supply in Australia. The TGA regulates a range of therapeutic goods, including prescription medicines, non-prescription medicines, complementary medicines, medical devices and biologicals. The focus of this consultation is the following types of therapeutic goods:

Before a therapeutic good can be marketed in Australia, it must be approved by the TGA and entered on the Australian Register of Therapeutic Goods (ARTG). Where the TGA is not satisfied that a medicine meets safety, quality and, where applicable, efficacy criteria, approval is not granted. Interested persons can access and search the ARTG on the TGA website.

Medicines that are registered on the ARTG have been assessed by the TGA against quality, safety and efficacy criteria. This includes all prescription medicines and non-prescription medicines, such as pain killers and hay fever medicines. Medicines that are listed on the ARTG have been assessed against quality and safety (but not efficacy) criteria. This includes most complementary medicines.

All medicines carry some risk to consumers and in making decisions about whether or not to approve a medicine, the TGA assesses whether the benefits that it could provide to consumers outweighs the risks to consumers. For example, an anti-cancer treatment may have serious side-effects but may nevertheless be approved by the TGA because of its ability to treat a life-threatening condition.

Once a medicine has been approved for supply in Australia, the TGA monitors its ongoing safety and quality by conducting a range of monitoring activities, such as audits of efficacy, manufacturing facilities, collection and assessment of adverse reaction reports and laboratory testing of product samples. The TGA also works with international medicines regulators to identify signals that may indicate a safety issue associated with a medicine. Where such signals are detected, the TGA has the powers to take appropriate regulatory action, including product recalls, requiring the addition of warning statements to medicine labels or adding conditions to the continued supply of the medicine.

How the TGA contributes to the quality use of medicines by Australian consumers

The TGA administers the therapeutic goods legislative framework within the context of the National Medicines Policy, which is a collaborative arrangement between the government and bodies that represent healthcare practitioners, pharmacists, medicines consumers, medicines industry and the media to improve the health of Australians by delivering on the following overarching objectives:

  1. Timely access to the medicines that Australians need at a cost individuals and the community can afford
  2. Medicines meeting appropriate standards of quality, safety and efficacy
  3. Quality use of medicines
  4. Maintaining a responsible and viable medicines industry.

The TGA's contributions to the National Medicines Policy are illustrated in Figure 1.

Figure 1
Figure 1: TGA's contribution to the National Medicines Policy

The mandatory requirements for information that must be provided to consumers on medicines labels and packaging, and the way this information is presented, make an important contribution to the safe and quality use of medicines by Australian consumers and health care professionals. In particular, the TGA assesses the potential for the information and the way it is presented to be confusing or misleading to consumers and health care professionals. The aim of this aspect of the medicines regulatory framework is to reduce the risk of errors by health care professionals and facilitate consumer access to the information they need to:

  • make informed choices where they are self-managing minor conditions, such as a headache or a cold
  • safely use a medicine that they have been prescribed by a health care practitioner for the treatment of a more serious condition.

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