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.
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.
TGA can take regulatory action as necessary against medicines found to be unsafe with respect to elemental and solvent impurities, regardless of the transition period.
How to use this guidance
This guidance is not provided as a legal interpretation of TGO 101. It includes clarification on, and information relating to, mandatory requirements. It also includes additional information to assist medicine sponsors in meeting their obligations and best practice recommendations.
The information in this guidance may also assist other stakeholders to understand how sponsors and manufacturers assure that medicines that are tablets, capsules or pills are of good quality.
When the words 'must' or 'required' are used, a legal requirement is being described.
Compliance with TGO 101 is not necessarily sufficient to demonstrate quality, safety or efficacy for the purposes of registering or listing a medicine. Additional requirements may be applied, for example, as conditions of listing or conditions of registration.
In some instances, compliance with TGO 101 may not be sufficient to establish the safe use of medicines. Sponsors will need to further consider the intended patient population, size of the recommended daily dose, etc. to ensure that their medicines are safe for the purpose for which they are to be used.
Consideration must also be given to any other relevant standards.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.