Draft list of permitted indications: Frequently asked questions

5 July 2017
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General questions about permitted indications

'Indications' are statements that describe a therapeutic use for a medicine. In relation to listed medicines, a 'therapeutic use' means 'use in, or in connection with, influencing, inhibiting or modifying a physiological process in persons'.

Permitted indications are indications that have been assessed against a set of criteria and determined to be appropriate for low risk listed medicines that are not assessed pre-market.

Statements that do not describe a therapeutic use, such as: marketing claims (for example: 'Contains ingredients of plant origin'); and structure/function claims (for example: 'Calcium is a component of bone) are not indications.

Permitted indications have a consistent structure and terminology to describe the therapeutic uses that are appropriate for listed medicines. Permitted indications are made up of the components shown in the Diagram 1.

Diagram 1: Indication components

Action qualifier (e.g. 'Help') + Action (e.g. 'relieve') + Target qualifier (e.g. 'mild') + Target (e.g. 'dry skin')

All permitted indications contain an action and a target, for example: 'Relieves (action) itchy skin (target)'. In some cases, an action and a target can be included in a single word, for example: 'galactogogue' which is a traditional term that means 'increase' (action) 'breast milk' (target).

'Action qualifiers' and 'target qualifiers' are sometimes included in a permitted indication to ensure that the indication is low risk. They may be used sometimes to ensure that an indication is not referring to a restricted representation (that is a serious form of a disease, disorder or condition), for example: 'Help (action qualifier) relieve mild (target qualifier) arthritis'.

The list of permitted indications will be made as a legislative instrument and will be registered on the Federal Register of Legislation. It will contain a comprehensive list of permitted indications that have been assessed as being compliant with the regulatory requirements. The legislative instrument will also include 'requirements', such as required label advisory statements, relating to the use of permitted indications in a listed medicine.

Questions about what is on the list of permitted indications

We have developed the draft list of permitted indications based on industry submissions to previous TGA public consultations (undertaken as part of the 2011 ANAO Audit recommendations). We have also undertaken ongoing targeted consultation and workshops with industry groups in 2016 and 2017.

We will continue to refine the list of permitted indications ahead of implementation. You now have the opportunity to propose additional indications to be added to the draft list, at no cost, until 31 October 2017. For more information on timing, please see the Timeline for implementation.

Indications for listed medicines cannot refer to or imply to:

  • the 'treatment, cure or alleviation' of any disease, condition, ailment or defect. In this context, these terms are considered to imply the complete resolution of the disease, condition, ailment or defect:

And, except for in the prevention of skin cancer through the use of sunscreens, indications can not refer to

Yes.

Some lower level indications have been included where they are appropriate, for example: 'Aid/assist/helps the transport of glucose into cells'.

However, in general, references to biomarker levels (for example: glucose, cholesterol, blood pressure levels) are considered be risk factors for serious diseases (such as: diabetes and cardiovascular disease). Further, the measurement of biomarker levels cannot be self-assessed and requires ongoing medical supervision. Consistent with the eligibility criteria for low risk indications, indications implying serious diseases and those that cannot be self-diagnosed or self-managed are not included in the list of permitted indications.

Yes.

A number of specific indications for sunscreens have been included in the draft list of permitted indications so that sunscreen products can continue to be entered on the ARTG via the listing pathway. The permitted indications for sunscreens are consistent with the current Australian Regulatory Guidelines for Sunscreens (ARGS).

Questions about adding indications and evidence qualifiers to the draft lists

You have until 31 October 2017 to propose new indications for inclusion in the draft list of permitted indications free of charge. For more information see What do I do now?.

Following implementation of the list of permitted indications, you will be able to apply to the TGA for new indications to be added to the list, which will be updated quarterly. An application fee will apply. Further information on the fees and administrative processes associated with new indication applications will be provided on the TGA website in the coming months.

You have until 31 October 2017 to propose additional evidence qualifiers free of charge. After 31 October 2017, all applications for new evidence qualifiers will incur a fee. For more information see What do I do now?.

Please note that only proposals for new evidence qualifiers referring to 'traditional contexts', 'target populations', 'TCM patterns' and/or 'time of use' will be considered. Statements relating to directions for use (for example: 'when taken daily') or claims of efficacy (for example: '25% more effective') and other marketing claims will not be considered.

The TGA will assess all indications against a set of criteria to confirm that they are appropriate for use in low risk listed medicines. For more information refer to the Criteria for permitted indications fact sheet.

Indications that do not meet the criteria for a permitted indication will not be included in the list.

If you currently have a listed medicine that has an indication that does not meet the criteria for a permitted indication you will have to amend your medicine's ARTG entry (and consequently your medicine label and promotional material) before the end of the 3 year transition period.

Alternatively, if you would like to continue to make a higher level indication for your medicine, you can apply to have the medicine listed in the ARTG via a pre-market assessment pathway. More information on new pre-market assessment pathways will be provided on the TGA website in the coming months.

No.

Permitted indications will not be linked to ingredients or products and the TGA will not assess whether there is evidence to support their use in listed medicines. It will continue to be the sponsor's responsibility to ensure that their medicine meets all the requirements for listing. This includes that:

  • the medicine only contains low risk ingredients
  • sponsors hold evidence for all indications made for their medicine
  • the overall presentation of the medicine (including the label and any promotional material) must be suitable for a listed medicine and comply with advertising requirements.

Questions about using permitted indications

Yes, provided you hold appropriate evidence to support the use of that indication for your medicine. Refer to Guidelines on the evidence required to support indications for listed complementary medicines.

Yes.

The legislative instrument will include requirements relating to the use of certain indications in a listed medicine. The requirements help ensure that the indications are suitable for listed medicines that are not pre-market assessed. The requirements may specify circumstances when an indication can or cannot be used or specify conditions that must be met. For example, requirements may:

  • Specify a vulnerable population for which the indication is not suitable, such as children.
  • Require a warning statement to be included on product labels, such as 'If symptoms persist consult your healthcare practitioner (or words to that effect)'.

Your listed medicine must comply with any requirements that apply to the use of your selected indication. The legislation will allow for cancellation of a medicine from the ARTG if the requirements relating to the use of the permitted indication are not complied with.

When you enter your medicine on the ARTG via the Electronic Listing Facility (ELF), you will be able to select evidence qualifiers from drop down lists to make your permitted indication more specific to align with the evidence you hold for your medicine. This may also help you to differentiate your medicine in the marketplace.

Four types of optional evidence qualifiers will be available for selection:

  • Traditional context: This specifies the traditional paradigm, for example: 'Traditionally used in Western herbal medicine'. The traditional context is a mandatory qualifier for indications where the sponsor holds evidence of a tradition of use. They are not applicable for indications supported by scientific evidence.
  • Traditional Chinese Medicine (TCM) patterns: These are available for Traditional Chinese Medicines only and use TCM specific terminology to describe the underlying pattern causing symptoms of a condition or illness, for example: 'Spleen Qi Deficiency pattern'.
  • Target population: This specifies the target population for the medicine, for example: 'in healthy individuals', 'in women', 'in men'.
  • Time of use: This indicates the time of use (but not directions for use), for example; 'after exercise', 'before eating'.

Diagram 2 shows how evidence qualifiers may be used with permitted indications.

Diagram 2: Use of permitted indications with evidence qualifiers

Evidence qualifier: Traditional context: Mandatory for indications supported by a tradition of use (e.g. 'Traditionally used in Chinese medicine to') + Permitted indication (e.g. 'Relieve digestive discomfort') + Optional evidence qualifiers: TCM pattern (e.g. 'in deficient stomach Qi pattern'); Population (e.g. 'in elderly individuals'); Time of use (e.g. 'after eating')

When selecting an evidence qualifier, the sponsor of the medicine is responsible for ensuring that the indication remains low risk and remains eligible for listing. The legislation will allow for cancellation of a medicine from the ARTG if the use of an evidence qualifier makes a medicine ineligible for listing.

When entering their medicine on the ARTG, applicants for Traditional Chinese Medicines (TCM) will be able to select a combination of TCM specific indications, other traditional indications or general indications. Applicants will also be able to select from the list of TCM patterns to add to any of the core permitted indications, where it is appropriate and consistent with the TCM paradigm to do so. Examples of possible TCM combination indications are:

  • 'Dispel Wind Heat' (TCM indication) to 'help relieve mild migraine symptoms' (General indication).
  • 'Harmonise the stomach' (TCM) in 'Stomach Rebellious Qi pattern' (TCM pattern).

You will not be required to include the permitted indication in your medicine's ARTG entry 'word for word' on your medicine label. However, the indication on the ARTG and on the medicine label must have the same intent and meaning.

For example: If the indication: 'Maintain/support bowel regularity' was included in a medicine's entry on the ARTG:

  • 'Helps maintain regular bowel movements' would be considered to have the same meaning; but
  • 'Relieves constipation' would be considered to be a different meaning.

Sponsors should apply caution when not using a 'word for word' approach because the presentation of the medicine may become unacceptable and non-compliant with the listed medicines requirements and/or the Therapeutic Goods Advertising Code. There will be provisions in the Act to cancel a medicine from the ARTG if the medicine advertises an indication that is not included in the medicine's ARTG entry.

An eligibility criterion for a permitted indication is that it must be capable of complying with the Therapeutic Goods Advertising Code when included on the product label or promotional materials.

However, the inclusion of an indication in the permitted indications list does not mean that the use of the indication in a medicine's advertising material is compliant with the Advertising Code. Amongst other factors, how the indication is used and the overall presentation of the medicine will determine if the medicine is compliant with the relevant regulatory requirements.

Questions about changes to regulatory requirements and changes in ELF

Yes.

The introduction of the list of permitted indications will introduce a new requirement whereby sponsors can only select indications for their medicine from the prescribed list. Your other regulatory obligations will remain the same.

Yes.

At the end of the transition period all listed medicines must only contain indications from the list of permitted indications. This means that you will be required to log on to the Electronic Listing Facility (ELF) and update your existing listings.

To minimise the regulatory burden on industry and keep compliance costs to a minimum, you will not be charged an application fee to update your existing listing during the first 18 months of the transition. Further information on fees and the transition period will be provided on the TGA website in the coming months.

The Electronic Listing Facility (ELF) will continue to look and function in the same way. However, there will be some changes to the listed medicine application form. These changes are outlined below:

  • The 'free text field' for entering indications will no longer be available.
  • When sponsors enter their medicine in the ELF, they:
    • will select permitted indications from a drop down list; and
    • may also choose to select evidence qualifiers from drop down lists to make a permitted indication more specific and align with the evidence they hold for their medicine.