The TGA has announced key information on the new provisional approval process for prescription medicines.
The new process was recommended as part of the review of medicines and medical device regulation with the parliament backing the implementing legislation earlier this year.
Under the provisional approval process, breakthrough medicines that do not meet the TGA's full clinical data requirements can be granted a time-limited approval of two years plus potential extensions.
To be eligible for provisional approval, a medicine must meet all the criteria, starting with the requirement that it be a new medicine or indication.
The medicine or new indication must be a major advance and used for the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition. There must be no registered alternative treatments or preliminary data on the new medicine must demonstrate it represents a significant improvement in efficacy or safety compared to an existing therapy.
Preliminary data could be based on a non-validated surrogate endpoint, single-arm study, non-randomised comparison, interim analysis, small database, or recruitment from a narrow group of patients.
In addition, the sponsor company must have provided sufficient evidence of a plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the provisional registration period.