Posted by Michael Wonder on 15 Feb 2017
Proposed changes to accessing unapproved therapeutic goods through the Authorised Prescriber and Special Access Schemes
15 February 2017 - The TGA is seeking comments from interested parties on the proposed changes to the Special Access Scheme and the Authorised Prescriber Scheme.
The Medicines and Medical Devices Regulation Review made three recommendations to improve access to unapproved therapeutic goods through changes to the Special Access and Authorised Prescriber Schemes. These are outlined in recommendations 24, 25 and 26 of the document Review of Medicines and Medical Devices Regulation - Recommendations.
The recommendations made are to decrease duplication of work undertaken and to streamline access to unapproved therapeutic goods which are considered to have an established history of use.
