Priority review designation
A step-by step guide for prescription medicines
This guidance assists sponsors with the process for applying for Priority review designation for the registration of a prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
To assist you with understanding the eligibility criteria and supporting documentation requirements for Priority review designation, please see the eligibility criteria and supporting documentation guidance.
Priority review designation
Purpose of designation
We will assess your application for designation before you lodge a submission for registration to determine whether the medicine is eligible for registration via the Priority review pathway.
Priority review designation is a formal decision to accept a Priority review designation application, which forms a determination under Section 25AAA of the Therapeutic Goods Act 1989.
The designation application is the formal application made using a specified form requesting assessment against the relevant eligibility criteria and a decision from TGA (see section 16Q of the Therapeutic Goods Regulations 1990).
Granting of a designation is an 'entry ticket' to the Priority review pathway and does not guarantee acceptance of the submission for registration or successful registration on the Australian Register of Therapeutic Goods (ARTG).
Benefits of designation
A valid designation must be held in order for benefits resulting from designation to apply to a submission for registration on the Australian Register of Therapeutic Goods (ARTG).
Priority review designation can provide:
- access to expedited assessment via the Priority review pathway
- a consistent and transparent process for assessment against the eligibility criteria
Medicines with Priority review designation have the same evidence requirements as other prescription medicines and will be evaluated by TGA for quality, safety and efficacy in the same way.
For more information, please refer to the guidance on the Priority review registration process.
Specific eligibility criteria for the Priority review pathway are set out in section 16R(2) of the Therapeutic Goods Regulations 1990. See the Priority review designation eligibility criteria and supporting documentation guidance for details of the eligibility criteria and associated definitions.
As part of the implementation of the Priority review pathway we have developed implementation arrangements that will apply from the anticipated implementation date of 1 July 2017 until 31 December 2017.
Designation process for Priority review
See the Designation process for Priority review diagram for an overview of the designation process.
Step 1: Providing early notification of your designation application
If you have not previously contacted TGA about your intended designation application, you are strongly encouraged to notify us at least one month prior to lodgement.
Early notification will assist us with resource planning which contributes to the timely assessment of your designation application and submission for registration.
You can make this notification informally by sending an e-mail to AET.Application.Entry.Team@health.gov.au, including details of the planned:
- designation/s to be sought
- the active ingredient
- the sponsor's name
- the proposed indication for designation.
In place of the early notification, you may request a pre-submission meeting with TGA to discuss a planned Priority review designation application and subsequent submission for registration. The content and procedures for these meetings are as per the standard prescription medicines pre-submission meetings process.
Pre-submission meetings can be a useful opportunity for you to obtain advice from us about the intent of the eligibility criteria for Priority review designation. However, TGA cannot provide binding advice at a pre submission meeting on whether your application will be granted Priority review designation.
For Priority review, we recommend that pre-submission meetings occur between three and six months prior to the planned date of submission for registration (and therefore should occur up to three months prior to lodgement of your designation application).
If the pre-submission meeting is greater than six months from the planned date of the submission for registration lodgement, then we suggest that an email is also sent to the Application Entry Team, as per the 'early notification' section.
Step 2: Verifying your access to TGA Business Services (TBS)
If you already have a client ID number and password to access TGA Business services, go to Step 3.
Client identification and access to Business services
Designation applications are created and lodged by people with Submitter access through the TGA Business Services portal.
You will need the following to make an application:
- a TGA Client ID number
- password access to our TGA Business services portal
- Submitter access to the TBS portal
If you do not have a Client ID number or access to our business services:
- go to our TGA Business services: getting started with TGA and
- submit the online organisation details form.
Step 3: Preparing your designation application
Before you begin your designation application, please check whether you have previously notified TGA of your intent to lodge (see Step 1).
Administrative requirements for Priority review designation
To obtain Priority review designation, you need to ensure that you meet the relevant administrative requirements outlined in the section below. Meeting the administrative requirements is separate to satisfying the eligibility criteria that relate to the proposed clinical use of the medicine.
These requirements are captured in the designation application form, and must be met in order for your designation application to be eligible.
The administrative requirements will cover circumstances that are within your control as the sponsor. Failure to meet these administrative requirements may affect TGA's ability to expedite the assessment of your Priority review designation and registration applications.
How to meet the administrative requirements
To fulfil the administrative requirements, you must provide evidence of Good Manufacturing Practice (GMP) as part of your application for designation.
This includes either:
- evidence of existing approved GMP licence or clearance; OR
- verification that you have applied to obtain GMP approval for all manufacturing sites.
You must provide evidence of this by supplying the approved or submitted GMP clearance, certification or licence tracking number for all manufacturing sites relevant to the Priority review application as part of the designation application e-form.
Step 4: Submitting your designation application
We recommend that you submit your application for designation around three months prior to the date you plan to lodge your submission for registration.
Using the designation application e-form
Under Section 16Q of the Therapeutic Goods Regulations 1990, in order to be eligible, your designation application must:
- contain sufficient information for TGA to make a decision, AND
- be submitted using the approved form (the designation application e-form)
You can access the designation application e-form through your TBS account. See the designation e-form guidance for further guidance on filling out the form.
Please see the eligibility criteria and supporting documentation guidance for information on meeting the eligibility criteria and the requirements for supporting documentation to be attached to your designation application.
For any attachments, use the format outlined in Section 2.2 (Formatting for documents) of the general dossier requirements for prescription medicines.
Payment of the designation fee
A fee applies to Priority review designation applications. The Priority review designation fee amount is available at the fees and payments section of the TGA website (and Part 2, Schedule 9 of the Therapeutic Goods Regulations 1990).
When you submit your designation application through the TBS portal, an invoice for the designation fee will automatically be sent to you (the Submitter) and the Billing contact (if an email address has been previously provided) within 90 minutes. The invoice will also be available to people with Finance access on the TBS portal.
We do not refund fees for designation applications that are withdrawn before the decision is made or are assessed as ineligible for designation.
Applying for both Orphan drug and Priority review designation
If you intend on applying for both Orphan drug and Priority review designation for the same medicine and indication, this may be completed in parallel or sequentially. The proposed therapeutic indication for Priority review must be identical to, or a subset of, the Orphan indication. See the eligibility criteria and supporting documentation guidance for Priority review for further detail on receiving multiple designations for a single medicine.
Please note that although there is some overlap in the eligibility criteria for Priority review and Orphan drug designation and we allow joint justifications for certain criteria, (see eligibility criteria and supporting documentation guidance) where a designation application is made for both designations we will make each designation decision separately against the relevant eligibility criteria.
In order to be eligible for a waiver or refund of the Priority review designation fee, you must apply for Orphan drug designation either before or at the same time as your Priority review designation.
If you apply for both Priority review and Orphan drug designation, you will be required to pay the designation fee (a single fee is payable for Priority review only, given that there is no designation fee for Orphan drug designation).
Under section 43AD of the Therapeutic Goods Regulations 1990, if we consider your application to be eligible for Orphan drug designation the Priority review designation fee will be refunded (provided that the Orphan drug designated indication or a subset of the Orphan drug designated indication is the indication that is eligible for Priority review designation).
If you are applying for Priority review designation of a medicine that already has a valid Orphan drug designation and the orphan indication is the same as, or is broader than, the Priority review indication that you are applying for, your Priority review designation fee will be waived.
We do not refund the Priority review designation fee if you obtain Orphan drug designation after the Priority review designation as part of a separate designation application.
Step 5: TGA assessment of the designation application
The target timeframe for TGA's assessment and decision making on your designation application is up to 20 working days. Please note that more complex applications may take longer to assess due to the additional deliberation required.
After you have submitted your designation application using the e-form, we will check the information provided and confirm whether it is sufficient to allow us to assess the application.
We will check that your application:
- designation fee invoice has been issued (and the fee is paid prior to a designation decision being provided, if applicable)
- form has been completed in full, including declarations
- meets the administrative requirements
- has separately addressed each criterion of the relevant designation/s that have been requested with clear, robust and scientific justifications
- contains justifications that are up to date
- includes supporting data and references where required
You will not be provided with a formal notification of the results of this checking process, however, if required you may receive requests for further information.
If you have any questions during the designation application assessment period, please contact AET.Application.Entry.Team@health.gov.au.
How we will assess your designation application
The focus of the assessment will be to determine whether the application and supporting documentation establishes that the eligibility criteria are met.
Applications for designation will be reviewed against the eligibility criteria set out in section 16R(2) of the Therapeutic Goods Regulations 1990 by the relevant Clinical Evaluation Unit.
TGA may seek independent expert advice on aspects of the assessment if required.
A recommendation from the relevant Clinical Evaluation Unit will be referred to TGA's Chief Medical Advisor, who is the delegated decision-maker for designation applications.
Requests to the sponsor for further information
You may receive requests for additional information or clarification from TGA during the course of the assessment. These requests will include a timeframe for response and details of TGA contacts for your response. The standard timeframe for your response will be five working days.
It is your responsibility to provide TGA with sufficient evidence to allow the decision-maker to be satisfied that the eligibility criteria have been met.
The designation assessment and decision-making timeframe of 20 working days applies only to TGA time spent. Any time taken for you to respond to requests will extend the overall assessment and decision-making timeframe. If no response is received in the specified time period, TGA will make a decision based on the available information.
If our assessment finds that your application is likely to be ineligible for designation, you will be provided with the opportunity to review the decision prior to finalisation. In this circumstance, you will have a period of five working days to provide TGA with a statement of perceived errors of fact or omission.
Withdrawing your designation application
You may withdraw your designation application at any time before we issue a designation decision.
To withdraw the application, email AET.Application.Entry.Team@health.gov.au.
Your email should include:
- a statement that you wish to withdraw a designation application
- the designation application number
- the active ingredient
- the sponsor's name
- the proposed indication for designation.
We will not publish applications for designation that are withdrawn before a formal designation decision is issued on our website.
Withdrawn applications are not eligible for a refund of the Priority review designation fee.
Step 6: Notifying sponsors of the designation decision
You will generally be notified of TGA's decision regarding your designation application within 20 working days of receiving the designation application (excluding any additional time taken for you to respond to TGA requests).
If TGA assesses that your application for designation is eligible, the designation will be approved.
After the delegate has made a decision, you will be advised of the outcome as soon as practicable in writing via a notification letter issued via email which will include:
- details of designation(s) eligible/ineligible and the relevant indication
- a statement of reasons for designation decisions (for ineligible decisions only)
- the date on which the designation (if approved) lapses (six months after the date on which you are notified of the designation decision)
- details of your appeal rights
- notice that at the time of lodging your submission for registration, you must have lodged all of the required evidence in support of the GMP application for all manufacturing sites relevant to the Priority review application.
How to appeal the designation decision
The Priority review designation decision is appealable under Regulation 48 of the Therapeutic Goods Regulations 1990.
Appeals regarding ineligible designation decisions may be lodged by the applicant only and must be lodged within 90 days of the designation decision being issued.
Publication of designation outcomes
If your designation application is approved, TGA will publish details of the eligible designation decision on its website.
Publication will include:
- the name of the medicine
- the sponsor's name
- the eligible Priority review indication
- designation decision date and lapsing date
- designation status (i.e. active or lapsed)
Designation decisions will be published as soon as possible after you have been notified.
We will not publish details of designation applications that are assessed as not eligible or those that are withdrawn before we make a decision.
Maintaining a valid designation
To be eligible for Priority review designation, it is your responsibility to ensure that your designation application includes all relevant information and that the justifications provided in the designation application are supported by the data in your submission for registration. TGA will consider this at the time of assessing your designation application, and then will re-assess as part of the dossier acceptance process when you lodge the submission for registration (see the Priority review prescription medicines registration process).
Lapsing or revocation of the designation
Eligible Priority review designations will automatically lapse six calendar months after the date that you are notified of the designation decision, as outlined in Section 16S of the Therapeutic Goods Regulations 1990.
To be eligible for the Priority review pathway, the relevant designation must be active at the time of submitting your application for registration (this refers to the dossier, not the Pre-submission Planning Form). Because the purpose of the designation is to provide an 'entry ticket' only, after the submission for registration is received, the active or lapsed status of the designation is no longer relevant.
TGA reserves the right to revoke the designation prior to the end of the six month lapsing period under section 16T of the Therapeutic Goods Regulations 1990. This may occur if:
- we have not received the submission for registration, OR the submission has been received but it is not effective; AND
- TGA is satisfied that the medicine no longer meets the eligibility criteria.
However, we will not routinely review designation decisions during their validity.
If TGA decides to revoke your designation, you will be advised in writing as soon as practicable after the decision has been made.
Decisions regarding revocation of designations are appealable under regulation 48 of the Therapeutic Goods Regulations 1990 by the sponsor only.
Extension of designations
Priority review designations cannot be extended. If you wish to use the Priority review pathway and your Priority review designation has lapsed, you must submit a new designation application and pay another designation fee.
Re-lodgement of lapsed designation
If you wish to seek Priority review designation following a lapsed designation application (for a therapeutic good and indication that has been previously designated but where the validity of the designation has lapsed) you will need to lodge a new designation application.
We will re-assess the new designation application against the eligibility criteria, as some aspects such 'comparison against existing therapeutic goods' may have changed since the original designation decision was made.
For re-lodged applications, you are required to provide the reference number/s for previous designation applications.
If you require further assistance regarding the designation process
If you have read the guidance and still need our assistance, contact AET.Application.Entry.Team@health.gov.au.
Step 7: Submitting your application for registration
You will have until the lapsing date nominated in the designation decision letter to provide a submission for registration.
However, in the interests of expediting registration for Priority review medicines we encourage you to provide your submission for registration on the date you specified in the designation application form. Priority review submissions for registration must be provided in eCTD format.
Please notify us as soon as possible at AET.Application.Entry.Team@health.gov.au if it comes to your attention that the date of your submission for registration is likely to vary from the date specified on your designation application form.
Designation process for Priority review
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|V1.0||Original publication||Prescription Medicines Authorisation Branch||01/07/2017|