Thursday, 7th March, 2019

Australia’s Therapeutic Goods Administration transparency reforms

As part of ongoing transparency reforms, the Therapeutic Goods Administration (TGA), Australia’s therapeutic goods regulatory body, is seeking comment on whether it should disclose earlier that a prescription medicine is being evaluated for registration in Australia.

Currently, the TGA does not release information about the acceptance of an application for prescription medicine evaluation, nor about the ongoing evaluation of applications, unless this information is already publicly available. This is on the basis that information as to whether an application for registration has been made is commercially sensitive and should be confidential to the applicant. Under the current approach, the existence of an application will usually only become public when the outcome of consideration by the TGA results in its registration on the Australian Register of Therapeutic Goods.

Overseas regulators take varying approaches to publication of medicine applications under evaluation. European and Canadian regulatory authorities notify the public when they accept a prescription medicine for evaluation, while the United States Food and Drug Administration does not. In New Zealand, Medsafe lists all applications for registration on a public database where the evaluation status of those applications is regularly updated.

The TGA is seeking comment on whether its current approach should change and, if so, which of the following options should be adopted:

  • List all applications accepted for evaluation.

  • List all applications, but at two different time points, with the time of publication varying according to whether the medicine is a new medicine or a generic medicine or biosimilar.

  • List applications of innovator medicines of highest public interest, but not generic or biosimilar medicines.

The deadline for responses is 29 March 2019. If you have any questions about what is being proposed, or would like to submit a response, please contact us