Australia – Guidance for TGO 101

Standard for tablets, capsules and pills

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.

Transition period

The requirements that applied to tablets and capsules under Therapeutic Goods Order No. 78 Standard for tablets and capsules (TGO 78) have been adopted into TGO 101. This means that, generally, a transition period is not needed for these medicines. Sponsors can elect to move to alternative testing requirements, where this is permitted under the Order, at any time. Details on how to request this type of change are provided later in this document.

The TGO 101 requirements that apply to pills commence on 31 March 2021. Pills were not subject to TGO 78. The delayed commencement allows sponsors two years to update their manufacturing documentation and ensure that their goods will comply with the new requirements by the end of March 2021.

A two-year transition period has also been specified in relation to section 16 of the Order. This allows sponsors time to review the manufacturing documentation for their medicines and update them in line with the requirements for elemental impurities and residual solvents in tablets and capsules.

All tablets, capsules and pills subject to the Order and released for supply after 30 March 2021 must comply with TGO 101…