6.3 Management of parallel process submissions
The TGA–PBAC parallel process allows applicants to submit Category 1 and Category 2 submissions relating to medicines and vaccines to be evaluated and considered by the PBAC at any time from the lodgement of a TGA registration dossier.
Applicants are required to have lodged a registration dossier with the TGA prior to making a submission to the PBAC. Vaccine submissions must also include advice from the Australian Technical Advisory Group on Immunisation (ATAGI), and the submission must have addressed matters raised in the ATAGI advice prior to lodgement of the submission to the PBAC. The applicant 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 5.9). The PBAC will defer making a decision where there is specific or missing information that cannot be obtained from the applicant and is required for PBAC decision-making (e.g. TGA delegate’s overview or MSAC advice in relation to a codependent technology).
A medicine will not be listed on the PBS before it is registered on the Australian Register of Therapeutic Goods.
The PBAC outcomes for items submitted under parallel process that are recommended or deferred, will not be published until a positive delegate’s overview has been received, and the Public Summary Document will not be published until the medicine is registered for that indication by the TGA. The PBAC outcome and Public Summary Document for items submitted under parallel process and receiving a rejection will be published in accordance with the standard timeframes.
Parallel processing is not available to Category 3 and Category 4 submissions to the PBAC or submissions requesting the listing of a biosimilar medicine.
Further information about the arrangements for parallel process submissions is available on the PBS website.