6.3 Management of parallel process submissions

Page last updated: October 2016

Since 1 January 2011, the Australian Government has allowed major submissions to be evaluated at any time from the lodgment of a TGA registration dossier. This policy is called the TGA–PBAC parallel process.

The sponsor is responsible for providing the PBAC with all TGA documents that it receives after lodging a submission. It is preferable that the documents are received as early as possible in the evaluation process (refer to Section 5.7).

Where the TGA has not generated a TGA delegate’s overview by one week before the PBAC’s meeting, the PBAC may defer its final decision regarding a recommendation for subsidy or not recommend the medicine.

A medicine is not listed on the PBS before it is registered on the Australian Register of Therapeutic Goods.

The PBAC does not provide information on its consideration of a submission to the public through an outcome statement until the TGA delegate’s overview is prepared. The Public Summary Document is not published until the medicine is registered for that indication by the TGA.

To date, parallel processing of submissions with the TGA has not been extended to minor submissions or  vaccine submissions.

 

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