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Applying for inclusion of a Class 2, 3 or 4 biological on the ARTG - a step-by-step guide
Australian Regulatory Guidelines for Biologicals (ARGB)
This page is for sponsors and potential sponsors and navigates you through the stages of preparing and submitting an application for inclusion of a Class 2, 3 or 4 biological in the Australian Register of Therapeutic Goods (ARTG).
If you are new to supplying a therapeutic good, you may find our overview of applying for market authorisation helpful.
For new Class 2, 3 and 4 biologicals
This application process is specific to inclusion of new biologicals on the ARTG that are:
- new biological entities classified as Class 2, 3 or 4 biologicals
- a new biological based on a parent biological already on the ARTG.
This is not the correct process if you want to apply:
- to vary a biological already included on the ARTG, you may need: Varying biological entries on the ARTG
- for inclusion of a Class 1 biological; you need go to Applying for inclusion of a Class 1 biological on the ARTG
- make a change to a biological (parent biological) already on the ARTG where the change creates a separate and distinct good (new biological), you need to go to new biological based on a parent biological.
Before you apply
There is a considerable amount of information you need to collate before you will be able to apply for inclusion of a biological in the ARTG.
To assist you in preparing for your application, we suggest reading:
Overview of the application process and timeframes
The overall time to evaluate a dossier can vary depending on:
- the quality and complexity of the dossier
- issues raised during the evaluation process and timely response from sponsor
- consideration by the Advisory Committee on Biologicals, if required.
The following Table highlights the standard process for acceptance and review of an application to include a new biological in the ARTG.
|Phase||Stage||Description||Target timeframes*||Legislated timeframe*|
|2||Submission||Submitted information/data & application fees||-||30|
|Notification of outcome of preliminary assessment||30|
|3||First round of Evaluation||Round 1 Evaluation||100||255|
|4||First round of request for information from sponsor||Response to first s32JA letter from applicant||30**|
|5||Second round of Evaluation||Round 2 evaluation||20|
|5a||Second round of request for information from sponsor||Response to second s32JA letter from applicant||30**|
|5b||Third round of Evaluation||Round 3 evaluation||20|
|6||Expert advisory review||Consult the Advisory Committee on Biologicals, if required||40-60|
|-||Total evaluation timeframe||200-220||-|
|8||Post-decision||ARTG entry and other administrative processes||20|
* Timeframes are stated in working days.
** These times represent typical timeframes given to you to respond to requests for information, but may be much longer.
Where a request for further information is made the evaluation is stopped and the period it takes for you to respond is not calculated in the evaluation timeframe.
In some circumstances, we may also stop the clock by mutual agreement with you and restart when the issue has been resolved. For example, when the evaluation has been complete but GMP certification of a manufacturing site has not been granted.
Phase 1: Pre-submission
Pre-submission meetings are available to all sponsors considering supplying a biological.
We highly recommend a pre-submission meeting with us for all Class 3 & 4 biologicals, including CTX applications.
We also encourage pre-submission meetings for Class 2 biologicals.
Advice on classification of your biological
We can assist you with classification of your biological if you complete the Request for advice on biologicals form.
Phase 2: Submission
The submission process for Class 2, 3 and 4 biologicals includes the following stages:
- Complete and submit the biologicals application form through TGA Business Services following the Biologicals application form - a step-by-step guide.
- Submit supporting documentation
- Pay the application fee
- Preliminary assessment
- Pay the evaluation fee
Only after steps 1-3 have been completed is your application considered effective, and can your application proceed to preliminary screening.
Complete the application form
Your application form and required documentation must be submitted separately for Class 2, 3 and 4 biologicals.
To request inclusion of your biological in the ARTG you need to complete and submit the electronic biologicals application form available on the TGA eBusiness Services portal.
Information on completing and submitting the application form is provided in:
Who can draft and submit the form?
Only people assigned permission as a drafter or submitter can create or edit forms. Their roles differ:
- drafter - can draft a form but cannot submit a form
- submitter - can draft and submit a form
Your TGA Business Service administrator allocates permissions.
We suggest reading Preparing your biologicals application for inclusion in the ARTG for guidance on the following:
- whether single or multiple ARTG entries are required for your products
- whether multiple applications can be submitted together as a single submission.
Submit supporting documentation
All of the required documentation outlined in Preparing your biologicals application for inclusion in the ARTG must be submitted with your dossier, as outlined in How and where to send your dossier.
Pay the application fee
For Class 2, 3 and 4 biologicals, the application fee is payable on each request for inclusion:
- The application fee:
- The application invoice will be generated automatically once you submit your electronic application in TGA Business Services.
- The invoice must be paid within 14 days.
- We will not start our preliminary assessment of your application until you have paid your application fee and we have received the data.
To pay your fee, use one of the payment options.
Once the application form has been received, the application fee paid and supporting documents received we will review your submission to make sure you have provided all of the required information.
We will notify you within 30 working days with the outcome of our preliminary assessment.
During the preliminary assessment we determine whether the below have been met in relation to the application:
- The application is made
- in accordance with the form approved for that class of biological.
- The prescribed application fee for that class of biological has been paid.
- The application has been delivered to us.
- The application is accompanied by information required in the dossier, as specified in 32DDA (9) & (10) of the Act.
The dossier is reviewed to ensure that supporting information is provided in all required sections of the dossier, but the quality or accuracy of the information is not assessed at this stage.
We will verify that your GMP applications are effective (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 Australian manufacturing licences and overseas GMP certification at the time of making the application.
Where gaps in the supporting information are identified, you will be given the opportunity to supply the additional information. Where there is a significant delay in supplying the additional information a mutual stop clock may be applied.
Where supporting information requested is not available a decision may be made that the application does not pass the preliminary assessment.
If your application passes the preliminary assessment:
- Our evaluation process starts - the clock starts (day 1) the day after we notify you.
- We send you an invoice for the evaluation fee within seven days.
- You have 28 days to pay your evaluation fee in full. There are no provisions for payment by instalment.
Pay the evaluation fee
For Class 2, 3 and 4 biologicals, a full evaluation fee is generally payable for each request for inclusion. A reduction or waiver of the evaluation fee is possible:
- for applications submitted as a single submission
- if an application only requires an abridged assessment.
Guidance on these provisions is available in: Preparing your biologicals application for inclusion in the ARTG.
The evaluation fee:
- the evaluation invoice is generated after we have completed the preliminary assessment and we have notified you of the outcome of the preliminary assessment
- the evaluation fee must be paid within 28 days.
To pay your fee, use one of the payment options. There are provisions for payment by instalment.
Phase 3: First round of evaluation
During the first round of evaluation we review your submission to ensure that:
- the quality, safety and efficacy of the biological have been satisfactorily established for the proposed use(s)
- the presentation of the biological is acceptable
- the biological conforms to all applicable standards
- if a step in the manufacture of the biological has been carried out outside Australia and the biological is not exempt from the operation of Part 3-3 of the TG Act - that the manufacturing and quality control procedures used in the step are acceptable
- the biological does not contain substances that are prohibited imports for the purposes of the Customs Act 1901
- all the manufacturers of the biological are nominated as manufacturers of the biological in the application
- other matters (if any) that the Secretary considers relevant.
The evaluation of your dossier involves many specialist areas within TGA, e.g. quality, infectious disease safety, microbiology, toxicology and clinical areas.
Phase 4: First round of request for information from sponsor
If additional information is needed, we will:
- consolidate the questions from each of the evaluation areas before providing them to you
- prepare a request for information letter, under section 32JA of the Therapeutic Goods Act 1989
- stop the clock from the time section 32JA request is made until you submit the requested information.
Generally, we propose a response period of 6 weeks (30 working days). In some circumstances the response time may be substantially longer, for example if additional supporting material needs to be generated.
Where the same or similar questions are posed by different areas of the TGA, please respond to each question, although it is appropriate to cross-reference the responses.
Phase 5: Second round of evaluation
During the second round of evaluation, we will:
- restart the clock once the requested information has been received
- evaluate the additional information (20 working days)
Note that if only a partial response is received by the due date then a deadline for submission of the additional information will be set with you. The clock will remain stopped and the evaluation of the partial information provided will not begin.
If substantial additional supporting data is provided at this stage a longer evaluation time may be negotiated with you.
Phase 5a: Second round of consolidated request for information from sponsor
For biological applications it is common that further substantial questions will still remain after the second round of assessment.
If we need to request additional information from you, we will prepare a consolidated letter, under section 32JA of the Therapeutic Goods Act 1989.
We stop the clock from the time section 32JA request is made until you submit the requested information.
Phase 5b: Third round of evaluation
As per Phase 5.
For any issues still outstanding following evaluation of the responses, we may work closely with you to resolve them during the review and decision phase or we may highlight them for the consideration of the decision maker.
Reports are finalised by each evaluation area and provided to the delegate for consideration and drafting of the Product Overview. At this point the decision maker will choose whether to seek advice from the Advisory Committee for Biologicals.
Phase 6: Expert advisory review
The TGA delegate will review the evaluation reports and where required, may seek advice from the Advisory Committee on Biologicals (ACB). This process can take up to 2-3 months.
When preparing the request for ACB advice, the delegate will consider any outstanding issues from the evaluation process. The request includes:
- an overview of the application including key findings from the evaluation reports
- outstanding issues identified by the delegate
- an account of the risks and benefits relevant to the proposed product and proposed indication(s)
- a specific request for advice on any aspect of the application's characteristics, findings, or risk/benefit considerations
- whether special conditions of inclusion should be imposed.
Your input to the ACB meeting
Once we have prepared the request for the ACB, you will receive a copy.
- You should review our request to the ACB.
- You may advise us of any perceived errors of fact or major omissions in the evaluation reports.
- You may compile a pre-ACB meeting response and provide a final comment on the application.
The ACB does not:
- make decisions.
The outcome of the ACB meeting will be provided to you.
The ACB minutes may also be provided to some overseas regulatory agencies as permitted under section 61(4) of the Therapeutic Goods Act 1989.
Phase 7: Decision
When making the decision, on whether to include a biological on the ARTG, the delegate will review all documentation associated with the application, including:
- the application and submission dossier
- the evaluation reports
- responses to requests for information
- advice from expert advisory committees
- other relevant advice or information
- consider whether the quality, safety and efficacy of the medicine have been established.
Where there are any outstanding issues that may affect the decision, the delegate may liaise directly with you during this phase before finalising the decision. For example:
- the final labelling and product information sheets
- negotiation of any non-standard conditions of inclusion
- the application form may be returned to you to check that all of the information is correct, including the certification of the manufacturers and the final agreed intended use or indications.
Once the decision is made we will send you a written notification of the decision.
If the decision is:
- to include your biological on the ARTG, the decision letter will outline any specific conditions that apply to your biological. You must comply with all imposed conditions.
- not to include the biological on the ARTG, the decision letter will outline the reasons for the decision and information on your rights to seek a review of the decision.
Phase 8: Post decision
The post-decision phase starts when you are notified of the delegate's decision.
If your application for inclusion in the ARTG was successful you need to:
- read, understand and comply with all standard and specific conditions outlined in your notification letter
- download your biologicals certificate of inclusion from TGA Business Services
- check your ARTG entry is correct.
- If you do not comply with all of the conditions imposed by the delegate of the Secretary your biological may be cancelled from the ARTG.
Date of effect of the inclusion
- The inclusion of your biological will commence on the day specified in the certificate of inclusion.
- The biological cannot be lawfully imported, exported or supplied by the applicant prior to this date.
|Version||Description of change||Author||Effective date|
|V1.0||Original publication incorporating new legislative changes and information previously published on the TGA website.||
Biological Science Section
Regulatory Guidance Team