All therapeutic goods must comply with applicable standards, which determine the consistency of product quality, before they can be entered in the Australian Register of Therapeutic Goods (ARTG).
Standards tell you how to:
- manufacture your ingredients
- create your dosage form (for example, make a tablet or pill)
- perform any tests on the quality of your product or ingredient
- correctly label and package your medicine.
Standards that can apply to you
Therapeutic goods orders
Any matter specified in an order has precedence over requirements of the default standards.
Therapeutic goods orders (TGOs) are made by the Minister under section 10 of the Therapeutic Goods Act 1989 (the Act).
Common orders that may apply to you:
- Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
- Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95)
- Therapeutic Goods Order No. 100 - Therapeutic Goods (Microbiological Standards for Medicines) Order 2018
- Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019
Default standards
Default standards can tell you how to manufacture your ingredients and your dosage form. These are publicly available and are recognised under the Act.
They are provided by the:
- British Pharmacopoeia
- European Pharmacopoeia
- United States Pharmacopeia – National Formulary.
Compositional guidelines
There is a list of compositional guidelines for ingredients permitted for use in listed medicines.
If the ingredient is subject to a default standard, you have to comply with applicable standard. If an ingredient is not subject to a default standard or has a compositional guideline, a list of tests with acceptance criterion and analytical procedures references, should be established as a part of total control strategy to ensure quality for the intended use.
Australian/New Zealand standards
The TGA can adopt Australian/New Zealand standards (refer to Part 3-1 paragraph 10(2)(a) of the Act). For example, the Australian/New Zealand Sunscreen Standard.
Australian/New Zealand Sunscreen Standard
The Sun Protection Factor (SPF) of therapeutic sunscreens must be determined by testing on human skin in accordance with the Australian/New Zealand Sunscreen Standard (Australian Sunscreen Standard).
See Updates to the Sunscreen Standard for the latest information on using this standard.
Guidance and resources
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GuidanceGuidance to assist in meeting the Australian labelling requirements in TGO 91 and TGO 92.
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GuidanceGuidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).
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GuidanceGuidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).
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Reference materialA compositional guideline is a summary of descriptions, tests and limits that define the composition and characteristics of a substance approved for use in listed medicines as either an active substance or an excipient.