Changes Affecting Submissions for Unapproved Therapeutic Goods

The Therapeutic Goods Administration (TGA) has announced plans to transition Special Access Scheme (SAS) and Authorised Prescriber (AP) submissions to a fully digital model. Once this is implemented, paper-based submissions (including faxed and emailed submissions) will no longer be accepted.

The online system has been designed to allow real-time access to notifications and submission data across multiple platforms, e.g. computer, smart phone, tablet, etc. Transition to this system is intended to improve the security of interactions between the TGA and healthcare practitioners and simplify these processes.

The transition process will be occurring in two stages, with the TGA providing the following proposed timeline:

• 1 April 2024 (Phase 1)
  • Submissions for SAS Category B pathway and AP scheme will only be accepted via the SAS/AP Online System.
• 1 July 2024 (Phase 2)
  • Submissions for SAS Category A and C pathways will only be accepted via the SAS/AP Online System.

In 2023, 84% of SAS and AP submissions were received via the online system. Of the submissions that utilised a paper-based method, the majority were for SAS Category A and C pathways and generally originated from tertiary hospitals. The longer transition time for moving these pathways to the online system is hoped to provide hospitals with adequate time to change their processes.

Pathways for accessing unapproved therapeutic goods

The TGA encourages the use of TGA-approved medications, i.e. medications entered on the Australian Register of Therapeutic Goods (ARTG). This ensures that the therapeutic good has been evaluated by the TGA for quality, safety, and effectiveness. However, there may be times when a therapeutic good is required that is not on the ARTG. In these cases, the SAS or AP pathways may be considered.

The SAS can be used to access unapproved medications for individual patients. The SAS is divided into three categories:

• Category A
  • The patient must be seriously ill with a condition from which death is reasonably likely to occur within months or premature death is reasonably likely in the absence of early treatment
  • Unapproved products can be accessed immediately
  • The TGA must be notified within 28 days of use
  • The prescriber must be a medical practitioner
• Category B
  • The TGA must be provided with a brief clinical justification to support the use of the good for the medical condition in question
  • TGA approval is required before the therapeutic good can be supplied
  • This category may be used by medical practitioners and other health practitioners
  • Goods that may be accessed depend upon the health professional’s scope of practice, qualifications, condition being treated, and state/territory requirements
• Category C
  • Includes a range of unapproved therapeutic goods that the TGA deems to have an established history of use
  • Unapproved products can be accessed immediately
  • The TGA must be notified within 28 days of use
  • All listed criteria must be met in order to prescribe a product listed in Category C.

Medical practitioners can use the AP pathway to access unapproved medications for multiple patients with the same condition. Authorised prescribers do not need to seek approval for each individual patient but must provide the TGA with a report every six months of how many patients have been treated with each unapproved product.

The prescriber is responsible for deciding which pathway should be used in each case. An interactive tool is available on the TGA website to guide decision making. Suspected adverse events or defects must be reported to the TGA within 15 days of learning of the issue.

Background to transition

In 2015, the Medicines and Medical Devices Regulation (MMDR) review recommended the TGA create an online system to improve access to unapproved goods. The TGA launched their online system in 2018 with the intention of fully transitioning to digital submissions by July 2019. However, user feedback suggested that further improvements were required before the online system could be used exclusively.

Since then, the TGA has made a significant investment in improving the system, including:

• Improvements to the user registration process;
• Streamlined navigation of the application process;
• Redistribution of the TGA workforce to improve internal efficiencies in processing submissions;
• A streamlined process for therapeutic vape submissions;
• Improved functionality of AP reporting to reduce administrative burden; and
• The ability for pharmacists to validate the application and notification status in real-time.

Additional upgrades are planned for this year to improve security and efficiency. For example, health practitioner registration status will be automatically validated against the Australian Health Practitioner Regulation Agency (AHPRA) registry to prevent the creation of fraudulent accounts. Ways to optimise how information is managed and shared within organisations are also being investigated. The TGA will continue to review and seek feedback on the system to optimise efficiency.

Further information

• The TGA provides guidance for the SAS and AP Online System
• The TGA can also provide direct assistance in transitioning to the online system by emailing [email protected]