On 5 July 2017, the Therapeutic Goods Administration (TGA) released a draft list of permitted indications and evidence qualifiers which it proposes be used by listed medicine sponsors to enter product indications in the Australian Register of Therapeutic Goods (ARTG).
Indications are statements that describe a therapeutic use for a medicine. The Therapeutic Goods Act 1989 defines a 'therapeutic use' as any 'use in, or in connection with, influencing, inhibiting or modifying a physiological process in persons'. Permitted indications are indications that are appropriate for low risk listed medicines that are not assessed pre-market (such as vitamins and herbal medicines). Currently, the regulations allow sponsors of listed medicines to determine their own indications by use of a ‘free text field’.
In its 2017 consultation paper, Reforms to the regulatory framework for complementary medicines: Assessment pathways, the TGA noted that the current application process generated non-compliant indications. The consultation paper concluded that a list of permitted indications should be introduced via legislative instrument to standardise the indications being used on medicines.
The TGA’s draft list of permitted indications contains 1,345 indications. Permitted indications will be required to include an ‘action’ and a ‘target’, for example, ‘relieves (action) itchy skin (target)’. The TGA has also introduced a draft list of evidence qualifiers. ‘Action qualifiers’ and ‘target qualifiers’ may also be included to ensure that identification of a permitted indication is low risk, for example, 'Help (action qualifier) relieve mild (target qualifier) ear ache'. The proposed changes will also implement requirements relating to the use of certain indications, such as label advisory statements relating to their use as a listed medicine.
Indications must comply with the Therapeutic Goods Advertising Code when included on the product label or promotional materials. For example, an indication must not mislead, or be likely to mislead consumers.
Stakeholders can comment on the draft list up until 31 October 2017 and may propose new indications or evidence qualifiers. After this deadline, any proposal for new indications on the list will be subject to an application fee.
The TGA will review and consider the public feedback before finalising the legislative instrument, which will take effect from 1 January 2018. Once the reforms have taken effect, the free text option in the application will be removed. Existing listed medicines will be given a transition period of 3 years to be re-listed using the permitted indications, with re-listings within the first 18 months being exempt from fees.
This reform is important to all sponsors of existing listed medicines and anyone who will be seeking to list their medicine in the near future. These parties should review the draft lists published by the TGA to ensure that they are satisfied with the currently proposed options. Because an application fee will apply to any proposal made after the 31 October 2017 deadline for public comment (and would only be considered from 1 January 2018), now is the time to consider the suitability of these draft lists for any current or forthcoming products.
The draft list of permitted indications can be found here and the draft list of evidence qualifiers can be found at here. Comments and proposals can be submitted to the TGA at firstname.lastname@example.org.
31 October 2017
Deadline for submitting comments or proposals
31 October 2017 - 15 December 2017
The TGA to finalise the legislative instrument and review proposals for new indications and evidence qualifiers. Proposals for new indications or evidence qualifiers will not be considered by the TGA until the reform comes into effect.
1 January 2018
Reform takes effect
Proposals for new permitted indicators subject to application fee
30 June 2019
Deadline for sponsors to re-list existing medicines using permitted indicators without application fee
1 January 2021
Deadline for sponsors to re-list existing medicines using permitted indicators with application fee