TGA changes to Authorised Prescriber and Special Access Schemes

TGA changes to Authorised Prescriber and Special Access Schemes

The Therapeutic Goods Administration (TGA) has released its response to the recent public consultation on changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS). Briefly, changes will include:

  • Using a criterion of ‘established history of use’ to identify unapproved therapeutic goods that could be notified to TGA
  • Extending the AP approval period to three years (devices) or five years (medicines) subject to delegate decisions
  • The TGA will not evaluate the clinical justification of the medical practitioner and instead will rely on the expertise of a Human Research Ethics Committee (HREC) or specialist college.

For more information, visit the TGA website.