Priority review registration process

For Priority review designated prescription medicines

7 July 2017

This guidance assists sponsors with the Priority Review registration process. It outlines the key differences between this process and the standard registration process for prescription medicines.

This guidance should be read in conjunction with guidance on the prescription medicines registration process.

Prescription medicines registration process

The standard registration process for prescription medicines consists of eight phases with eight milestones.

The Priority Review registration process also has eight phases but with some changes to reduce time to approval.

The standard registration process for prescription medicines is designed with a target timeframe of approximately 220 working days, as prescribed under Regulation 16A(2) of the Therapeutic Goods Regulations 1990) from acceptance for evaluation through to the delegate's decision.

The Priority Review registration process is designed with a target timeframe of 150 working days from acceptance for evaluation through to the delegate's decision.

Priority review registration process

You are responsible for providing TGA with all necessary information in a timely manner, so as to remain in the Priority Review pathway. If you cannot meet this requirement, Priority Review designation may be withdrawn and the submission will be transferred to the standard prescription medicines registration process pathway (see 'Exit criteria' for more information).

Eligibility for Priority Review registration

Before you lodge your submission for registration using the Priority Review pathway, you will need:

  • an approved Priority Review designation that has not lapsed (the designation lapsing date will be included in your designation notification letter)
  • to advise us of any material changes that may mean that our decision to grant an eligible designation would no longer be valid. We will assess this information and advise whether the designation is revoked on the basis of this or any other information.

Lapsed Priority Review designations

If your Priority Review designation has lapsed, you are encouraged to apply for the standard prescription medicines registration process pathway. Priority Review designations cannot be extended. If you wish to reapply for a Priority Review designation that has lapsed, you must submit a new designation application and pay the designation fee.

Application and evaluation fees

Application and evaluation fees are higher for the Priority Review registration process than the standard prescription medicines registration process. The fee amounts are available at the fees and payments section of the TGA website (and Schedule 9 of the Therapeutic Goods Regulations 1990, pending passage of required changes to the regulations).

The processes for invoicing and payment of these fees are the same as in the standard prescription medicines registration process.

Exit criteria from Priority Review

Exit criteria have been established to define circumstances that may affect the Priority Review registration process timeframes. Exit criteria may be triggered at any time during the registration process and may result in TGA transitioning the submission to the standard prescription medicines registration pathway (after assessment of the relevant circumstances).

Exit criteria applicable to the Priority Review pathway include situations where:

  • you do not respond to our requests for additional information within a reasonable timeframe i.e. no longer than 30 calendar days; OR
  • our evaluation of the data identifies significant safety concerns that require further assessment (noting that the assessment of safety in the Priority Review pathway will not be any less robust than for the standard prescription medicines registration process); OR
  • you provide us with unsolicited or more extensive data than was requested during the registration process (excluding the provision of new safety related data, which you must bring to our attention); OR
  • it comes to our attention that you will be unlikely to meet the Good Manufacturing Practice (GMP) requirements for registration (i.e. obtaining an approved GMP licence or clearance).

If the exit criteria are triggered and a decision is made to transition the submission for registration to the standard pathway, the submission would retain its Priority Review designation, but the target timeframe of 150 working days from acceptance for evaluation through to the delegate's decision would no longer apply.

In this situation, a mutual stop-clock would be applied and subsequent milestones in the registration process would require adjustment. As in any other situation where the scheduled milestones in the registration process change, you will be provided with an updated Evaluation Plan.

No fees are refunded when a Priority Review designated submission for registration transitions to the standard prescription medicines registration pathway due to triggering of exit criteria.

Phase 1: Pre-submission Planning Form (PPF)

For designated Priority review submissions for registration, this phase differs from the Prescription Medicine Registration PPF-only process in the following ways:

  • the PPF for Priority Review registration will follow the PPF-only pre-submission phase option (the PPF-only option), which requires the submission for registration to be in eCTD format
  • processing of your PPF will commence when it is received. This is different from the standard prescription medicine registration PPF-only process where the PPFs are processed on the first day of each month
  • in the PPF you will commit to a 30-day stop-clock for the section 31 response as part of the Priority Review registration pathway. This is different to the standard registration process where you can nominate either 30 or 60 calendar days to prepare your response
  • as in the standard PPF-only process, there will be no formal Milestone 1. You should proceed to lodge your entire submission for registration as soon as the complete submission number is visible on eBS. This will occur once TGA has added the relevant stream number based on your proposed indication (i.e. 'PM-yyyy-xxxxx-z-stream number'). Please contact if you experience any difficulties.

Phase 2: Submission phase

Advise TGA () as soon as possible of any changes to the planned lodgement date for your submission for registration (which you previously provided in your designation application form). Early notification of your planned lodgement date assists us to allocate the required resources so that validation and evaluation processes can begin as soon as possible after we receive your submission for registration.

Lodgement of your submission for registration

The submission phase is the same as for the prescription medicine registration process except for the following:

  • your Priority Review submission must be in the electronic Common Technical Document (eCTD) format
  • you must include a copy of the 'Priority Review designation notification letter' in Module 1.5.2 of the submission
  • ensure that your submission supports the evidence that was presented in the designation application to demonstrate that you continue to meet the eligibility criteria for Priority Review designation
  • the evaluation phase will commence as soon as possible after the submission for registration has been received, checked and accepted for evaluation. The clock will commence once you have been notified that the submission for registration has been accepted for evaluation.

We will provide you notification of our acceptance of the submission in a notification letter at Milestone 2 as per the standard prescription medicines registration process. Please note that as per the usual process, the Evaluation Plan will be subject to change during the registration process and you should always refer to the most recent letter for up-to-date timeframes.

Non-priority designated applications

In order to use the Priority Review pathway, all applications in your submission must have Priority Review designation. Submission of any related applications that do not have Priority Review designation (either because they are ineligible or because you did not apply for designation) are to be lodged separately to your Priority Review submission for registration via the standard prescription medicines registration process.

Good Manufacturing Practice requirements

Following on from the information that you have provided as part of the designation application, at the time of lodging a submission for registration to the Priority Review pathway you will need to:

  • provide the Good Manufacturing Practice (GMP) clearance, certification or licence tracking number for all manufacturing sites relevant to the Priority Review submission; OR
  • demonstrate that you have applied to obtain GMP approval for all manufacturing sites and provided the required supporting evidence with the GMP application. We will verify that your GMP application is effective as part of the submission for registration acceptance process (i.e. confirm that you have paid the required GMP application fees and all of the required evidence to support the GMP application for all relevant manufacturing sites has been lodged in support of the application).

Evidence requirements are detailed in the Licencing and Certification guidelines and GMP clearance guidelines at the time of making the application.

For further information on Good Manufacturing Practice requirements for Priority Review designation and registration process refer to the Priority review designation process guidance and the Exit criteria for Priority Review registration process in this document.

Phase 3: First round assessment

This phase is the same as for the prescription medicine registration process except for the following:

First round assessment

The duration of this phase will be approximately three months, whereas five months is allowed for the standard registration process.

We will request information as required throughout the evaluation (referred to as 'rolling questions'). You are required to provide your response to us in a timely manner. A reasonable timeframe for response will be specified at the time a request is made, but is typically around two weeks and will not exceed 30 calendar days. The timeframe of responses will be commensurate with the amount of information that has been requested from you.

The return of responses to rolling questions is proposed to occur as a validated eCTD sequence to and .

TGA will continue to progress the evaluation while you prepare your responses to rolling questions. TGA does not intend to link these rolling questions to a stop clock, unless there are exceptional circumstances requiring us to do so. If there are no outstanding questions, no consolidated section 31 request will be sent at the end of first round of assessment.

First round assessment reports

In contrast to the standard registration process, first round assessment reports will not be provided at the end of the first round of assessment, or with the consolidated section 31 request (if required). However, sufficient context will be provided with rolling questions and/or the consolidated section 31 request for information to assist you to provide your responses promptly.

Phase 4: Consolidated section 31 request response

This phase is the same as for the prescription medicine registration process except for the following:

Section 31 request for information

Any rolling questions identified two weeks prior to completion of phase 3 (Milestone 3) and/or any unanswered questions will be summarised into a consolidated section 31 request and will result in a 30-day stop clock to allow you to prepare the response. If you do not respond within the 30-day stop clock, your submission will be transitioned to the standard prescription medicines registration pathway (see Exit criteria).

If there are no outstanding questions at this stage, no section 31 stop clock will occur and the submission will immediately proceed to the next phase (i.e. both phases of evaluation will be completed within four months if there are no stop clocks).

Phase 5: Second round assessment

This phase is the same as for the standard prescription medicine registration process.

At the completion of second round of assessment, you will receive the final evaluation report that includes consideration of your responses to the section 31 questions. You will have at least two weeks after receipt of the final evaluation report to notify us of any errors in fact or major omissions in the report.

Phase 6: Expert advisory review

This phase is the same as for the standard prescription medicine registration process except for the following:

  • the date on which your submission will reach this phase is subject to change as a consequence of the duration of the evaluation phase and whether a section 31 stop clock is required or not. You will be provided with updates to your Evaluation Plan during the registration process as required
  • priority review allows for flexibility in the expert advisory review phase. In addition to the scheduled Advisory Committee on Medicines (ACM) or Advisory Committee on Vaccines (ACV) meetings, an out-of-session expert advisory committee meeting may be required in certain circumstances.

Regardless of the mechanism for obtaining expert advice, the timeframes and procedures for exchange of information between you and TGA during this phase are the same as for the standard prescription medicines registration process.

As in the standard registration process, you will receive a copy of the delegate's overview of the submission.

Phase 7: Decision

This phase is the same as for the standard prescription medicine registration process.

Phase 8: Post-decision

This phase is the same as for the standard prescription medicine registration process.

Standard prescription medicines registration process diagram

Diagram showing the standard prescription medicines registration process

Priority review registration process diagram

Note: the timeframes in the diagram below represent maximum timeframes for each phase of the process as a guideline only. Not all steps may be necessary for every Priority Review submission for registration.

Diagram showing the priority review registration process

Version history

Version Description of change Author Effective date
V1.0 Original publication Prescription Medicines Authorisation Branch 01/07/2017
V1.1 Minor corrections Prescription Medicines Authorisation Branch 07/07/2017