TGA Issues New Guidance for TGO 101 (Standard for Tablets, Capsules and Pills)

The new guidance helps 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. The requirements that 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 commence on 31 March 2021 on enabling a 2-year transition period. 

The TGO 101 requirements that apply to pills start on 31 March 2021. Pills were not liable to TGO 78. The delayed commencement permits 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 indicated corresponding in relation to section 16 of the Order. This allows sponsors time to review the manufacturing documentation for their medicines and update them in accordance 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 follow TGO 101.

This guidance is not given as a legal interpretation of TGO 101. It provides explanation on, and data relating to, mandatory requirements. It also incorporates extra information to support sponsors in meeting their obligations and best practice recommendations.