FOI Request 1132-1819 in relation to Scheduling of Thymosin
The request is for the following:

“…the request submitted to the TGA for Scheduling of Thymosin Beta 4 and Tb500 as indicated in the link below.

https://www.tga.gov.au/book-page/27-performance-and-image-enhancing-drugs.

I am requesting specifically access to the application for inclusion of Thymosin Beta 4 and Tb500 on the Schedules List. I would request all supporting data that was
presented in the application that supports the claims.

Any/all clinical and scientific evidence that supports the claims of performance and image enhancement.

Any evidence that supports any medical benefit at all from the use of Thymosin Beta 4 or Tb500.

I would ask for clarification on what appears to be a contradiction in the rationale for the acceptance of the application. The reasons state limited evidence of therapeutic
benefits, not registered anywhere in the world (by definition no clinical evidence of efficacy or safety), experimental and yet it is accepted as being performance and image
enhancing.”
Schedule of Relevant Documents
Doc.  Folder Number
Document Number
Author
Addressee
Date
Description
Pages
Decision
Relevant Sections
No.
of the Act
1
E19-548637
D19-5424769
Third Party
ACMS #16
Nov 2015
Consolidated Agenda
20
Release in ful
Section 22(1)
November 2015
paper for ACMS #16
Meeting

1

FOI 1132-1819
ATTACHMENT A

Document Outline

Date