Australia Preps for Medicine Ingredient Name Changes

Regulatory NewsRegulatory News | 24 June 2019 |  By 

As part of a push to align the names of Australia’s medicinal ingredients with names used internationally, Australia’s Therapeutics Goods Administration (TGA) has been transitioning more than 220 ingredient names as part of a process that will last until 1 May 2020.

TGA acknowledged that over the years, some of the ingredient names in Australia have become out of date. And although some of the changes are minor spelling corrections (e.g., Amoxycillin to amoxicillin), others are more significant (e.g., Colaspase to asparaginase or Salcatonin to calcitonin salmon).

For the products seeing these more significant changes, TGA will require updates to the medicine labels with both the old and new ingredient name included for an additional three years after the end of the transition period (until 2023) to help consumers and health professionals become familiar with the new name.

“For example, medicines containing lignocaine will need to be dual labelled as 'lidocaine (lignocaine),'” TGA said. Sponsors of the medicines have known that the name changes were coming since 2016.

And TGA has provided sponsors with a checklist to make sure the May 2020 deadline is met, including reminder questions such as: “If you have advertising materials for your medicine that include ingredient names, is the right ingredient name used in those materials?”

TGA noted that generic drug sponsors can update ingredient names in their medicines documentation without waiting for the innovator to change their products.

Australia is also not alone in correcting certain ingredient names. The UK required similar changes in 2003 and New Zealand also did in 2008.

“Medicines with labels using the new ingredient names will gradually start to appear on shelves,” TGA said.
In addition to the ingredient name changes, TGA has reformed its labeling rules to make active ingredients more prominent, make the labels more consistent and to include allergy information, as well as allowing more space for additional information from a patient’s doctor. The new rules will take effect 1 September 2020.

Updating Medicine Ingredient Names

More Info on Labeling Changes


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