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Elemental impurities in traditional Chinese medicines (TCMs)

  • Post author:
  • Post published:03/01/2025
  • Post category:

Traditional Chinese medicines (TCMs) sold in Australia are carefully regulated to ensure safety and quality. They must meet limits on impurities like lead, arsenic, cadmium, and mercury, which can be…

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Updates to requirements and guidance for labels of injectable medicines

  • Post author:
  • Post published:03/01/2025
  • Post category:

Changes to TGO 91 for injectable electrolyte medicinesWe have made changes to Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) to make…

Continue ReadingUpdates to requirements and guidance for labels of injectable medicines

Automatic extension of Mutual Recognition Agreement (MRA) Good Manufacturing Practice (GMP) clearances

  • Post author:
  • Post published:03/01/2025
  • Post category:

GMP Clearances issued via the MRA pathway that are expiring on 31 December 2024 will be automatically extended until 31 December 2025. This is due to ongoing delays with MRA…

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Product Information safety updates – December 2024

  • Post author:
  • Post published:03/01/2025
  • Post category:

When new safety information for medicines is identified, the Therapeutic Goods Administration (TGA) works with the sponsors to update Product Information (PI) to ensure that health professionals and consumers have…

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TGA: Our Guidance pages have changed

  • Post author:
  • Post published:26/11/2024
  • Post category:

We have introduced new features to improve your experience using Guidance on our website.Guidance is now clearer to understand, easier to navigate and more reliable. It’s easier to keep track…

Continue ReadingTGA: Our Guidance pages have changed
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