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Provisional approval implementation arrangements
Version 1.0, March 2018
TGA is implementing a Provisional approval pathway for the registration of prescription medicines as part of the Government response to the Medicines and Medical Devices Regulation Review (MMDR). The pathway applies to new medicines or new uses for registered medicines which offer treatment options for serious illnesses, where none are currently available. Unlike other registered medicines, provisionally registered medicines are approved on the basis of preliminary clinical data as to their efficacy and safety, and their registration will be time-limited and subject to enhanced monitoring by TGA.
Provisional approval eligibility criteria
As the applicant, you are required to seek provisional determination before lodging a submission for provisional registration.
You need to meet all of the eligibility criteria, which are outlined in Provisional determination: eligibility criteria and supporting documentation.
Provisional approval implementation timeframe
The Implementation plan below applies to the first 18 months after the Provisional approval pathway is implemented. It describes the key features and estimated implementation dates for the first provisional determination and registration applications that we may receive and assess.
Implementation of the new Provisional approval pathway will occur in two stages, initial implementation, and review of processes and criteria.
Key steps in the implementation phase are:
- lodgment of the provisional determination application
- submission for provisional registration
We will publish the following on our website:
- guidance to help you compile and submit provisional determination and registration applications
- details of medicines that have been successfully granted provisional determination
- This implementation plan covers steps up to the first possible application for extension of provisional registration. Other steps will occur later on which are outside the scope of the current plan.
We will provide further information on the implementation of the Provisional approval pathway on our website as medicines progress through the pathway and we refine our processes.
TGA commences pre-submission meetings for sponsors who are interested in seeking Provisional approval determination
TGA commences accepting notices of sponsors' intention to lodge provisional determination applications
First determination decisions possible under the provisional determination process
Earliest opportunity to lodge Pre-submission Planning Form (PPF) with valid provisional determination with TGA
TGA starts to accept submissions for registration with valid provisional determination for evaluation under the provisional registration pathway. Submissions must be in eCTD format
Ongoing monitoring of the number of submitted determination applications, decision outcomes, and timeframes from determination application lodgement to decision
First possible provisional registration of a medicine with provisional determination
The impact of changes will be reviewed in the short term considering determination application numbers, determination outcomes and stakeholder feedback. The guidance material will be reviewed and updated if required
Medium-term review of the Provisional approval pathway (to assess the program once medicines have had sufficient time to complete the process of provisional registration)
First possible request for extension of provisional registration and/or acceptance of a submission to transition to full registration
Key features and estimated implementation dates for the first provisional determination and registration applications that we may receive and assess.
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||Prescription Medicines Authorisation Branch||