Pharmaceutical companies are able to support prescribers in their endeavours to deliver positive outcomes to patients who require access to medicines or devices that have not yet been approved in Australia.
Although Sponsors are not directly involved in the TGA authorisation process they can support prescribers with the importation and supply of identified products from their global portfolio, together with the necessary efficacy and safety data to allow for a smooth application process for prescribers.
The Therapeutic Goods Administration (TGA) has two schemes available to prescribers, both of which involve the import or supply of an unapproved therapeutic good.
- Special Access Scheme (SAS) which refers to arrangements which provide for the therapeutic good for a single patient, on a case by case basis. Patients are grouped into two categories under the scheme:
- Category A patients as ‘persons 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 patients are all other patients that do not fit the Category A definition.
- The Authorised Prescriber Scheme enables practitioners to gain authority to prescribe a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific patients (or classes of recipients) with a particular medical condition.
What kind of unapproved products can be supplied?
With the exception of drugs of abuse, any unapproved therapeutic good can potentially be supplied via the SAS or through an Authorised Prescriber.
The TGA applies a rigorous process to applicants before authority is granted for either of the schemes.
To discuss how we can be of assistance in this process, please call our Medical Services team on +61 3 9251 0777.
This article was written by Deidre Voss, Director, Medical Services.