Biologicals (priority applicant) determination

This guide is for sponsors intending to use the priority review pathway for biologicals.

It will assist sponsors with the process of applying for a biological (priority applicant) determination, also known as a priority determination, which is the first step of the priority review pathway.

Priority determination

The priority determination is a legislated requirement under subsection 32DEA(2) of the Therapeutic Goods Act 1989. This determination allows us to make decisions on whether biological products are eligible for inclusion in the Australian Register of Therapeutic Goods (ARTG) via the priority review pathway.

As a sponsor, you must submit a priority determination application and have this application approved before you can apply for priority review of a new biological.

The determination application is the formal application made using a specified form requesting assessment against the relevant eligibility criteria and a decision from the TGA under regulation 16V.

A priority determination is a prerequisite of the priority review pathway but does not guarantee acceptance of the inclusion application and subsequent inclusion of the biological in the ARTG.

The following diagram provides an overview of the priority determination process.

Benefits of determination

You must hold a valid priority determination for benefits resulting from determination to apply to an application for inclusion in the Australian Register of Therapeutic Goods (ARTG).

Priority determination can provide:

• access to expedited assessment via the priority review pathway
• a consistent and transparent process for assessment against the eligibility criteria.

When to submit your priority determination application

We recommend that you submit your application for determination 3 months prior to the date you plan to lodge your application for ARTG inclusion.

Eligibility requirements

Eligibility criteria for the priority determination are set out in subregulation 16W(2) of the Therapeutic Goods Regulations 1990.

For detailed information refer to priority determination eligibility criteria and supporting documentation requirements for biologicals. 

Administrative requirements

To obtain priority determination it is critical that you meet the relevant administrative requirements outlined below. The administrative requirements must be satisfied in addition to the eligibility criteria.

The administrative requirements, which are also captured in the determination application form, must be met for your determination application to be eligible for assessment.

Failure to meet these administrative requirements may affect our ability to assess your priority determination application.

Ensure that active ingredient(s) have an approved name

When recording the active ingredient(s):

• Check each active ingredient has one of the following approved terms:
  • Australian Approved Cell and Tissue Name (ACN)
  • Australian Approved Biological Name (ABN)
• Use the approved ingredient names in the application for priority determination.

If your active ingredient(s) is not in the list of approved names, you can submit a proposal for a new ingredient name to us before, or in parallel to, your application for priority determination.

• Make your application for an approved name using the relevant form:
  • ACN
  • ABN
• Use the proposed name (ACN/ABN) in the application form for priority determination, including the word 'proposed' in brackets after the name.

Applications for priority determination cannot be finalised until approved names have been allocated to new active ingredients.

Provide Good Manufacturing Practice (GMP) assurance

You must provide assurance that all manufacturing sites relating to your product have appropriate certification or licenses, or that the applicable GMP applications have been lodged with us.

This includes either:

• existing approved Australian manufacturing licence or overseas GMP certification
• verification that you have applied to obtain either an Australian manufacturing license or overseas GMP certification, as appropriate.

GMP clearance is not provided to overseas manufacturers of biological products as Australia has its own manufacturing standard for these product types. However, where manufacturing sites perform only sterilisation of these product types, GMP clearances may be provided.

For additional assistance, refer to the Good Manufacturing Practice application decision tree.

Determination application and assessment

See the Priority determination process diagram for an overview of the determination process.

Step 1: Provide early notification of your determination application

Early notification

If you have not previously contacted us about your intended determination application, we strongly encourage you to notify us at least 1 month prior to lodgement.

Early notification will assist us with resource planning which contributes to the timely assessment of your determination application and subsequent application for inclusion in the Australian Register of Therapeutic Goods (ARTG).

To make an early notification, email bloodandtissues@health.gov.au and include the following details of your planned application:

•  confirmation that biological priority applicant determination is being sought
• the name(s) of the active ingredient of the biological to which the determination relates
• the sponsor’s name
• the proposed priority indication that is, therapeutic indication (for class 3-4 biologicals) or intended clinical use (for class 2 biologicals)

Pre-submission meetings

In place of early notification, you may request a pre-submission meeting with us.

We recommend that pre-submission meetings occur up to 3 months prior to lodgement of your determination application. If the pre-submission meeting is more than 6 months from the planned date of lodgement of your application for inclusion in the ARTG, please notify us via an email as described in the early notification section.

You will need to provide details of your pre-submission meeting discussions when you lodge your application for inclusion in the ARTG.

Pre-submission meetings are an opportunity for you to obtain advice from us about your priority determination application. However, we cannot provide binding advice at a pre-submission meeting on whether your application will be granted a priority determination.

For more information refer to Pre-submissions with TGA.

Step 2: Submitting your determination application

We recommend that you submit your application for determination 3 months prior to the date you plan to lodge your application for inclusion of your biological in the Australian Register of Therapeutic Goods (ARTG).

Before you begin your determination application, please ensure you have previously attended a pre-submission meeting with us and/or notified us of your intent to lodge as detailed in Step 1.

After we receive your determination application, we will check whether the information provided is sufficient to allow us to assess the application.

We will check that:

• the application form has been completed in full, including declarations
• the application form meets the administrative requirements
• you have separately addressed each eligibility criterion with clear and robust scientific justifications
• your application contains justifications that are up to date
• your application includes supporting data and references where required.

If your application meets all requirements, we will issue an invoice for the determination application fee. Once your invoice is paid, we will start our assessment of your determination application.

Payment of the priority determination fee

A fee applies to priority determination applications.

The priority determination fee amount (as set by Part 2, Schedule 9A of the Therapeutic Goods Regulations 1990) is available at the fees and payments.

You must pay the determination fee in full via one of our payment options before we will process your application (see subregulation 16V(3)(b)). When we receive your determination application, an invoice for the determination fee and acknowledgement of your application will be sent to you (the submitter) and the billing contact (if separately provided).

A submission number for your application will be included in the acknowledgement that must be quoted in any subsequent correspondence with us regarding your application.

Please note that we do not refund fees for determination applications that are withdrawn before a decision is made or are assessed as ineligible for the determination.

Step 3: TGA assessment of the determination application

Under Section 16V of the Regulations, for your determination application to be eligible for assessment:

• it must contain sufficient information for us to make a decision
• be submitted using the approved form
• the determination application fee must be paid.

Assessment and determination decision timeframes

Our target timeframe for assessment and decision making on your determination application is 20 working days.

The timeframe for assessment begins on the day you pay the determination fee. Once you have made the payment, please send a copy of receipt to bloodandtissues@health.gov.au quoting your application number and invoice number.

For payment receipts received outside of business hours, we will begin assessment on the following working day.

If you have any questions during the determination application assessment period, please contact bloodandtissues@health.gov.au.

How we will assess your determination application

We will assess applications for determination against the eligibility criteria set out in subregulation 16W(2) of the Therapeutic Goods Regulations 1990.

Our assessment will focus on determining whether your application and supporting documentation meets these eligibility criteria. We may seek independent expert advice if required.

For more information refer to Biologicals (priority applicant) determination eligibility criteria. 

Requests to sponsors for further information

We may request additional information or clarification from you during our assessment of your application.

Our requests will include a timeframe and details of TGA contacts, for your response.

Timeframes for response are determined on a case-by-case basis. However, the usual timeframe for your response will be approximately five working days.

You are responsible for providing evidence in support of your application. If your response is not received in the specified time-period, we will make our determination decision based on the available information.

TGA timeframes and requests for information

The determination assessment and decision-making timeframe of 20 working days applies only to TGA time spent.

Any time taken for you to respond to our requests will extend the overall assessment and decision-making timeframe.

Withdrawing your determination application

You may withdraw your determination application at any time before we notify you of our decision. However, withdrawn applications are not eligible for a refund of the priority determination fee.

To withdraw your application, email bloodandtissues@health.gov.au the following information:

• a statement that you wish to withdraw a biological priority applicant determination application
• the determination application submission number
• the name of the active ingredient(s) to which the determination relates
• the sponsor’s name
• the proposed priority indication.

Step 5: Notifying sponsors of the determination decision

We will notify you by email of our decision on your determination application (subregulation 16W(4) of the Therapeutic Goods Regulations 1990).

If we assess that your application for determination is eligible, the determination will be approved.

Your decision letter will include:

• the name of the priority applicant
• each active ingredient of the biological to which the determination relates
• the priority indication
• notice that at the time of lodging your application for inclusion in the Australian Register of Therapeutic Goods (ARTG) you must have lodged all the required evidence in support of the GMP application for all manufacturing sites relevant to the priority application.

If we decide to refuse to make the priority determination, your decision letter will also include:

• the reasons for our decision to refuse to make a priority determination
• details of your appeal rights.

Appealing the determination decision

The priority determination decision is appealable under regulation 48 of the Therapeutic Goods Regulations, 1990.

Only applicants can appeal determination decisions

Appeals following refusal to make a priority determination must be lodged within 90 days of the determination decision being issued.

For more information refer to reconsideration of reviewable initial decision.

Publication of determination outcomes

We will publish details of biologicals with approved priority determinations as soon as possible after we have notified you of our decision.

Publications will include the:

• name of the biological product
•  applicant’s name
•  priority determination indication
• therapeutic area
• determination effective date and date on which it ceases to be in force (‘lapse date’).

We will not publish information on applications where we have refused to make a priority determination or on those that are withdrawn before a decision is made.

Period during which the priority determination is in force

Your priority determination comes into force on the day on that we notify you of our decision.

The determination will remain in force for 6 months (refer regulation 16X of the Therapeutic Goods Regulations 1990.) unless:

• it is revoked by us
• you make an application under section 32DD (of the Therapeutic Goods Act 1989) for inclusion in the Australian Register of Therapeutic Goods (ARTG).

If you submit a section 32DD application that passes preliminary assessment before the end of the 6-month period, the priority determination remains in force unless:

• you decide to withdraw the application
• the application for inclusion lapses in accordance with section 32DH of the Act
• a decision on the 32DD application for inclusion in the ARTG is made.

Please note that the above does not prevent us from converting your application from priority to standard during the evaluation process as a result of the exit criteria being triggered.

Revocation of priority determination

We reserve the right to revoke a priority determination if:

• either
  • we have not received an application for inclusion in the ARTG under section 32DD of the Act
  • an application for inclusion has been received but the application is refused at any stage of assessment
• we are satisfied that the biological product no longer meets the eligibility criteria for priority review. However, we will not routinely review determination decisions during their validity.

If we decide to revoke your priority determination, you will be advised of the decision and the reasons for the decision in writing as soon as practicable.

Decisions revoking priority determinations are appealable under regulation 48 of the Regulations by the applicant only.

No extensions of priority determination

Priority determinations cannot be extended.

If you wish to use the priority pathway and your priority determination is no longer in force, you must submit a new determination application and pay another determination fee.

Re-applying for priority determination

We will re-assess the new determination application against the eligibility criteria as some aspects (such as ‘comparison against existing therapeutic goods’) may have changed since the first assessment of your priority determination application.

You will be required to provide the reference number(s) for previous determination applications in your new application for determination.

Further assistance regarding the determination process

If you have read the guide and still need our assistance, contact bloodandtissues@health.gov.au.

Submitting your application for inclusion in the ARTG

You have 6 months from the date we notify you of our decision to grant a priority determination to submit an application for inclusion of your biological in the Australian Register of Therapeutic Goods (ARTG).

Applications for inclusion in the ARTG (made under section 32DD of the Therapeutic Goods Act 1989 ) are considered to be made at the time the application is received by us in an approved form or manner and accompanied by specified information (the dossier).

The priority determination must be in force on the date the application is made for the benefits of determination to apply.

Submission date

We encourage you to submit your application for inclusion in the ARTG on the date specified in your priority determination application form.

If the date of your application for inclusion is likely to vary from the date specified in your priority determination application form, please notify us as soon as possible at bloodandtissues@health.gov.au

For guidance on applying for priority inclusion refer to priority review process .