PRODUCT SUPPLY

Cyclotek extemporaneously compounds PET Radiopharmaceuticals made to order by customers for particular persons.

Supply mechanisms for FDG follow a standard product supply agreement, whereas other products are supplied under a Clinical Trial / Contract Manufacturing Agreement(s) or utilising the TGA Special Access Scheme or Authorised Prescriber rules.

None of the products being available for supply to the general public, and are only available to hospitals, doctors and certain other authorised persons.

  • All PET tracers other than FDG are currently considered by TGA to be unapproved medicines.
  • All compounded products by Cyclotek are manufactured to GMP standards in a TGA-licenced manufacturing facility. Where a Pharmacopeia Monograph exists, Cyclotek manufactures to that specification.
  • All Clinical Trials must have ethics approval in keeping with NH&MRC guidelines, with an appropriate Clinical Trials Notification (CTN) lodged with TGA.
  • SAS A or B schemes may be used, depending on the tracer and application. See the TGA website for more information.   https://www.tga.gov.au/form/special-access-scheme
  • Cyclotek must be supplied with copies of the CTNs or appropriate SAS forms
  • Cyclotek provides a regular consolidated report to TGA on the use of unapproved products using the special access scheme, which identifies the sites using such products

In addition to the above, Cyclotek and the imaging site need to have a Supply Agreement in place. This can be in one of several formats, which we would be glad to discuss with you. We can also provide you with more detailed information on the regulatory requirements mentioned aboveN