To the Editor: The Experimental Drugs Section (EDS) of the Drug Safety and Evaluation Branch of the Therapeutic Goods Administration (TGA) administers the clinical trial notification (CTN) and clinical trial exemption (CTX) arrangements for unapproved medicines used in clinical trials. These arrangements provide an avenue of “exemption”, whereby medicines that have not been approved for marketing in Australia are able to be supplied to patients within the context of a clinical trial approved by a human research ethics committee working under the guidelines of the Australian Health Ethics Committee (a subcommittee of the National Health and Medical Research Council). Although these arrangements cover only clinical trials in which unapproved medicines are used, a substantial number of such trials are carried out in Australia each year. (Clinical trials using unapproved medical devices that also use the CTN/CTX arrangements are administered by the TGA’s Office of Blood, Devices and Tissues and are not included in these statistics.)
Publication of your online response is subject to the Medical Journal of Australia's editorial discretion. You will be notified by email within five working days should your response be accepted.