TGA Issues new Therapeutic Goods Order – TGO 101 (Standard for tablets, capsules and pills)

The TGO 101 requirements commence on 31 March 2021 enabling a 2-year transition period.

This guidance is to help sponsors and manufacturers of medicines understand the role of the Therapeutic Goods Order No. 101 – Standard for tablets, capsules and pills (TGO 101, the Order) in ensuring that these types of therapeutic goods are of appropriate quality.” https://www.tga.gov.au/publication/guidance-tgo-101

The requirements previously applied to tablets and capsules under Therapeutic Goods Order No. 78 Standard for tablets and capsules (TGO 78) have been adopted into TGO 101 and as of 31/03/2021 will encompass pills.

“All tablets, capsules and pills subject to the Order and released for supply after 30 March 2021 must comply with TGO 101.” https://www.tga.gov.au/publication/guidance-tgo-101

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