AusBiotech Updates

TGA seeks comment on ‘low risk’ product regulation

4 May 2017: The Therapeutic Goods Administration (TGA) is seeking feedback on the future regulation of ‘low risk’ products in Australia, which encompasses products that pose little or no risk to the health of consumers.

This consultation seeks feedback on the possible regulatory options for different product types. It forms part of the Expert Review of Medicines and Medical Devices Regulation (MMDR), which made three recommendations in regards to low risk product regulation:

  • The first recommendation (Recommendation Fourteen), suggested that the Australian Government review the range of products listed in the Australian Register of Therapeutic Goods (ARTG).
  • The second recommendation (Recommendation Twenty-Three), suggested that the Australian Government review the range of products categorised as Class I medical devices.
  • The third recommendation (Recommendation Forty-Eight), suggested that the Australian Government review the range of complementary medicinal products, currently listed in the ARTG and subject to regulation under the medicines framework.

The consultation document, released in March 2017, stated that many of the options to reform regulation could be implemented without a harmful impact on public health and safety. It also maintained that reform would allow sponsors and the TGA to concentrate their resources on higher-risk products, which would be beneficial for patients across Australia.

AusBiotech members are invited to submit comment by Wednesday 10 May 2017 to Helen Arthur, National Programs Manager, on harthur@ausbiotech.org / 03 9828 1425. Alternatively, stakeholders can contribute comment directly to the TGA before Friday 12 May.

To find out more about the consultation on the future regulation of low risk products, visit the TGA website or download the consultation document.

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