Trade group backs changes for accessing unapproved therapeutic goods in Australia

Trade group AusBiotech has made a submission endorsing proposed changes to improved access options for unapproved therapeutic goods in Australia, which are intended to reduce time and administrative burden and greatly improve efficiencies for applicants.

The proposed changes to the Authorized Prescriber (AP) Scheme and the Special Access Scheme (SAS) have arisen from implementation of a number of Review of Medicines and Medical Devices Regulation (MMDR) recommendations.

While a number of pathways exist for Australian patients to gain access to products that have not yet been approved, the Therapeutic Goods Administration (TGA) consultation focused on the AP Scheme, which enables medical practitioners to prescribe unapproved therapeutics goods to a group of recipients, and the SAS, which allows an unapproved therapeutic good to be imported for one patient.