Submitting extension of indications applications that do not require supporting data

Guidance for sponsors

30 June 2015

This guidance is for applications for a new prescription medicine where:

  • the applicant proposes to group the new medicine with an already registered generic prescription medicine
  • the new medicine is an extension of indications and the proposed indication is in identical form to one already approved for the prescription medicine (the reference medicine) in respect of which the bioequivalence of the already registered generic medicine has been demonstrated
  • the application is one to which regulation 16G of the Therapeutic Goods Regulations 1990 applies (i.e. it does not need to be supported by clinical, pre-clinical or bio-equivalence data).

If your application requires supporting data, submit an application using the prescription medicine registration process.

Lower fees and shorter time frames

These applications have:

Do not combine an application for extension of indications that does not require supporting data with any other type of application in the one submission.

Separate and distinct goods

A successful application for extension of indications results in a new medicine because a different indication results in a separate and distinct good [Section 16(1) of the Therapeutic Goods Act 1989 (the Act)]. Your application is made under section 23 of the Act and our decisions are made under section 25 of the Act.

Only use this application type if you want to group the new medicine into an existing entry (thus it has the same ARTG number as the existing entry).

Steps in the application process

The process for making an application to which this guidance applies, consists of the following steps:

  1. Determining if your application requires supporting data
  2. Considering pack size
  3. Checking completeness of existing ARTG records
  4. Preparing Module 1
  5. Making your application
  6. Paying your fees
  7. Evaluating your application (TGA processing time)
  8. Providing patent certification or notification
  9. Printing your ARTG certificate
  10. Lodging the Product Information and CMI

Step 1. Determining if your application requires supporting data

To determine whether your extension of indications application requires supporting data, consider all of the following:

Explain why your application does not require data in section 5 of the application form.

Bioequivalence to reference medicine

We need to have previously evaluated data that demonstrated bioequivalence between your existing registered medicine and the reference medicine.

Reference medicine with identical indication

The reference medicine must have the identical indication to that for which you are applying.

Consider the appropriateness of the currently registered strengths of your medicine as they relate to the recommended doses for the new indication.

Be careful when using the Product Information for the reference medicine to support your extension of indications application. If the range of strengths available for the reference medicine differs from the range of strengths available for your medicine, then you need to consider how strengths relate to dose.

For example, if an indication requires a maximum dose of 1 mg and the lowest strength of your medicine is a 5 mg tablet, then the strength of your medicine is inappropriate for the recommended dose for the new indication.

Equivalence of all relevant pharmacokinetic parameters

For different indications, there can be different pharmacokinetic parameters that are relevant to safety and/or efficacy. The pharmacokinetic parameters that we evaluated previously in relation to the reference medicine should still be appropriate and suitable for the new indication. This is because your generic medicine must have the same safety and efficacy properties as the reference medicine (Schedule 9 of the Therapeutic Goods Regulations 1990).

Examples of pharmacokinetic parameters that are only relevant for some indications:

  • the median Tmax is important for indications that require rapid release from an oral dosage form
  • partial AUC values are sometimes important.

For more information see the TGA guidance on biopharmaceutic studies.

Other safety or efficacy issues

Consider any other issues related to the need for data to demonstrate that your medicine and the reference medicine have the same safety and efficacy properties.

For example, for non-absorbable polymers, demonstration of safety and/or efficacy for one indication cannot necessarily be used to support safety and/or efficacy for another indication.

Step 2. Considering pack size

The consumer needs to be able to comply with the recommended dosing regimens for the new indication.

Consider the adequacy of your currently registered pack sizes and pack size configurations for the new indications. If these are inadequate, apply to register additional pack sizes as part of your extension of indications application that does not require supporting data.

When you may add pack sizes

You may apply for additional pack sizes in an application for extension of indications that does not require supporting data, provided that the additional pack size:

  • is already registered to the reference medicine
  • is necessary for consumer compliance with one of the new indications
  • does not result in any changes to container material, size or shape, or any other change that may require the provision of stability data.

Pack size is defined on page 87 of Minor variations to registered prescription medicines: Chemical entities.

Changes to labels

If you apply for additional pack sizes, change the pack size descriptor on the label. Do not make other changes to the labels.

Providing a justification

On the application form, justify your decision on pack sizes:

  • If you are not applying for additional pack sizes, justify this in relation to the adequacy of current pack sizes to cover the recommended dosage regimen(s) for the new indications.
  • If you are applying for additional pack sizes, justify this in relation to:
    • the inadequacy of current pack sizes to cover the recommended dose regimens for the new indications
    • ability to add pack size without requiring new stability data.

Step 3. Checking completeness of existing ARTG records

Check the ARTG records of your existing medicines for which you are applying to extend the indications.

  1. Check:
    1. container type
    2. materials
    3. shelf life
    4. storage conditions
    5. quantitative formulation
    6. manufacturing sites
    7. manufacturing steps
    8. visual identification.
  2. Submit a 9D(1) request to correct an ARTG entry form if the ARTG entry is incomplete or incorrect.

Step 4. Preparing Module 1

Make sure your application, complies with the general dossier requirements.

Follow the general guidance about CTD Module 1 to complete all relevant sections of Module 1.

Module 1.0. Cover letter

Place your cover letter in Module 1.0.

In your letter, include:

  • the name of the new medicines and the active ingredient(s)
  • the type of application (extension of indications that do not require supporting data)
  • a brief justification for supporting data not being required, such as 'This application is only for an update of the Product Information so that it is in line with that of the reference medicine.'

Module 1.1. Comprehensive table of contents

Provide a comprehensive table of contents in the CTD.

Module 1.2.1. Application forms

Use the Extension of indications that do not require supporting data application form and place in Module 1.2.

Declarations

In the application form you will make a number of declarations, including:

Module 1.2.3. Patent certification or notification

We will need your patent certification or notification form before we can create your ARTG entries.

You do not have to do this at the same time as your application: see Step 8: providing patent certification or notification.

Module 1.3. Medicine information documents, packaging and labelling

Provide a draft

Do not submit labels; the only change you may make to labels is the pack size descriptor.

Only make changes to the medicine information documents if the changes are necessary:

  • because of the new indication
  • in order to make the format of the medicine information meet current requirements
  • because of the strengths available.

If the range of strengths covered by the reference medicines is not the same as for your medicines, consider adding information to the Dosage and administration section of the Product Information, such as the advice 'Use an alternative brand for doses that cannot be achieved with [your brand].' Do not name an alternative brand, because this is advertising.

Do not make minor editorial changes to the Product Information that are not necessary to meet current requirements.

Module 1.11. Biopharmaceutic studies

In Module 1.11 provide:

  • a tabulated summary of the pharmacokinetic parameters of the biopharmaceutical studies previously submitted
  • an explanation of why these data are applicable and satisfactory for the new indications.

For more information, see the TGA guidance on biopharmaceutic studies.

Step 5. Making your application

Complete the application form

Use the Extension of Indications that do not require supporting data application form. If you do not provide us with all of the information we ask for in the application form, there is a risk that your application will not comply with the requirements of section 23 and cannot be processed.

Do not combine an application for extension of indications that does not require supporting data with any other type of application in the one submission.

What to send to us

Send us:

  • the application form
  • Module 1
  • additional documentation required by the form
  • other supporting documentation.

Check the TGA general dossier requirements for information on how to submit your application.

Step 6. Paying your fees

There are two fees, an application fee and an evaluation fee. We recommend that you pay 100% of your invoice in the one payment.

To pay your invoice, follow the guidance at payment options.

For applications to be included in one submission with one application fee and one evaluation fee, all the medicines contained in the submission must contain the same active ingredients (see clause 1(3) in Part 1 of Schedule 9 to the Therapeutic Goods Regulations 1990).

Step 7. Evaluating your application

We will evaluate your application once:

  • we have received your application and the accompanying information
  • you have paid your application fee.

Time frame

We have a statutory time frame of 45 working days for these applications (regulation 16G of the Therapeutic Goods Regulations 1990 applies). However, the clock (that records TGA working days) does not start until you have paid your application fee and stops when we send you a formal request for information or make an objection.

We make a formal request for information under section 31 of the Therapeutic Goods Act 1989. This is the most common type of request that we make and usually consists of a request for existing information or documents relating to specific aspects of the application.

Alternatively, we may raise an objection to an application under regulation 16F. In an objection, we usually ask questions that need to be answered for a decision to be made. For example, if we think that data are required, we might raise an objection and ask you to justify why supporting data are not required. Once we receive your response to an objection we have thirty working days to make a decision, or the application is deemed to have been approved.

Possible outcomes

Each application may be:

If your submission consists of more than one application, we may approve some of your applications and reject others.

Approved applications

If an application is approved, you will receive a letter outlining the decision to register the medicines with the new indications and the conditions of registration.

You will be able to go to Step 8: Patent certification and notification.

Rejected applications

If an application is rejected, you will receive a letter:

Step 8. Providing patent certification or notification

If you have not already done so, send us a patent certification or notification form according to section 26B of the Therapeutic Goods Act 1989. We need to receive this before we can create your ARTG entries.

Step 9. Printing your ARTG certificate

Although the public can view ARTG entries and public ARTG summaries, these are not the same as ARTG certificates.

You can view and print your ARTG certificate the day following ARTG registration.

Step 10. Lodging the Product Information and CMI

In TGA Business Services lodge:

  • the approved Product Information within 2 weeks of registration as a text-searchable pdf document
  • the Consumer Medicine Information (CMI) within 2 weeks of registration.

Version history

Version Description of change Author Effective date
V1.0 Original publication Scientific Evaluation Branch and the Regulatory Guidance Team July 2015