THE Therapeutic Goods Administration (TGA) has launched a new consultation about proposed changes to accessing unapproved therapeutic goods via the Authorised Prescriber (AP) and Special Access Schemes (SAS).
Another initiative resulting from the government's response to the Review of Medicines and Medical Devices Regulation, the TGA is proposing the development of an online system to improve the pathways for access to unapproved therapeutic goods, which includes allowing applicants to enter information directly into the system.
An analysis of Authorised Prescriber applications shows that less than 1% were rejected, and those rejections arose because there was an alternative product included in the ARTG.
Of 20,000 Special Access Scheme category B (non-life-threatening) applications received annually just 0.3% were rejected - but despite this there was a high administrative burden for applicants and the TGA.
"The percentage of rejections identifies that a significant number of therapeutic goods currently used under the SAS B do not appear to pose an issue for public health and safety," the consultation document states.
Accordingly the TGA proposes to enable access to certain unapproved therapeutic goods via a notification process - rather than the current approval process.
Feedback on the proposals is sought, with a deadline for responses of 29 Mar 2017.
See tga.gov.au.
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