What are Therapeutic Goods?
Within Australia, the Therapeutic Goods Administration (TGA) is responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods through the Therapeutic Goods Act 1989 (Cth).
The TGA's website states that therapeutic goods can comprise a broad range of products which generally fall into the following categories:
Medicines - including prescription, over-the-counter and complementary medicines, such as paracetamol and echinacea
Biologicals - something made from or containing human cells or tissues, such as human stem cells or skin
Medical Devices - including instruments, implants and appliances, such as pacemakers and sterile bandages
What makes a good therapeutic?
The TGA broadly defines a therapeutic good as products that are developed for human use in connection with:
• Preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
• Influencing, inhibiting or modifying a physiological process
• Testing the susceptibility of persons to a disease or ailment
• Influencing, controlling or preventing conception
• Testing for pregnancy
This includes ingredients or components in the manufacture of therapeutic goods or things that are used to replace or modify parts of the anatomy.
Special Access Scheme
For therapeutics goods to be supplied in Australia, they must be entered on the Australian Register of Therapeutic Goods (ARTG). As part of the registration process, the TGA will evaluate the products for quality, safety and efficacy.
If a medical professional believes a patient may benefit from an unapproved therapeutic good, the prescriber can apply to the TGA for an approval to supply such goods. Patient approval is granted on a case-by-case basis.
The TGA's website outlines the following pathways:
Category A is a notification pathway which can be accessed by health practitioners on behalf of a prescribing medical practitioner for patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
Category B is an application pathway which can be accessed by health practitioners for patients that do not fit the Category A definition and where the unapproved good is not deemed to have an established history of use and cannot therefore be accessed through SAS Category C. An approval letter from the TGA is required before the good may be accessed.
Category C is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The goods deemed to have an established history of use are specified in a list along with their indications and the type of health practitioner authorised to supply these products for their respective indications.