AusBiotech endorses changes for accessing unapproved therapeutic goods


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

The proposed changes to the Authorised 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.

In regard to the AP Scheme, AusBiotech said there was merit in relying on the expertise of a human research ethics committee (HREC) or specialist medical college to approve the clinical justification of the use of the products. Also, extending the duration of AP Scheme approval for medical devices up to three years would contribute to significant time savings for both the TGA and the applicant.

With respect to the SAS Category B, AusBiotech requested that additional information regarding the details of the process be provided. For example, it would be valuable to know the estimated timeframe for the TGA to initiate the process. Similarly, AusBiotech questioned whether sponsors or health practitioners would have the ability to request the TGA to initiate the process for an unapproved good to be listed as notifiable under SAS Category B.

AusBiotech also supports the TGA’s intention to effectively engage with health practitioners, as their feedback is critical to the successful implementation of the changes.

AusBiotech’s submission included consultation from members, including feedback from the AusMedtech Regulatory Affairs Expert Panel.

Read AusBiotech’s full submission can be found here.