Australia's TGA Formulates New Steps for Drug Labeling and Packaging Review

Australia's Therapeutic Goods Administration (TGA) has reviewed the comments submitted on its Medicines Labeling and Packaging Review Consultation Paper, released in May 2012, and has identified six issues from the submitted comments that require further discussion with stakeholders:

• The need for some differences in the labeling requirements for different classes of medicine (prescription, over-the-counter and complementary);
• Evidence - the need, in subsequent analysis, to provide evidence that particular changes will improve medicine safety and the quality use of medicines;
• Greater clarity regarding which proposed options are to be mandatory versus voluntary;
• Assessment of the cost of particular options and the ability of industry to implement them;
• Harmonization of labeling plans with other jurisdictions where possible, including with New Zealand; and
• A commitment to undertake independent consumer testing of proposed options, followed by education and awareness programs once they are implemented.

As a result, TGA has formulated the following responses to the identified issues:

Need for labeling differences for Rx, OTC and Complementary Medicines
It is now proposed that labeling requirements will be specific to the class of medicine and will reflect the level of risk associated with the product.

Evidence
To assist in the assessment of the evidence for proposed amendments, the TGA will publish on its website a brief annotated bibliography is being prepared analysing the current shortcomings of labelling and packaging, as well as potential solutions to the identified issues.

Mandatory versus Voluntary 
The TGA will work with stakeholders to determine the best way to achieve the objectives of the review whilst ensuring that requirements are implementable and compliance can be achieved.

Harmonization with other countries, including New Zealand
The TGA, together with stakeholders, will investigate options for adopting and harmonizing better practice requirements from overseas regulators.

Assessment of cost and ability of industry to implement
TGA will work closely with industry to obtain verifiable information on the costs of particular labeling changes, and discussions held on whether there are any alternative labeling and packaging options that could achieve the same intent for a much lower cost.