In September 2016, the Government announced that the TGA would introduce a list of permitted indications that must be used by listed medicine sponsors to enter their product indications in the ARTG. There will be no option when listing a product for free text. The purpose cited by the TGA of establishing the list of permitted indications is to:
- ensure that listed medicines can only make low level indications that are suitable for medicines that do not undergo pre-market assessment
- provide transparency for sponsors on what indications are suitable for listed medicines to help prevent inadvertent non-compliance
- avoid consumers being misled by inappropriate indications on listed medicine labels.
Permitted indications will be assessed against a set of eligibility criteria to ensure that they are appropriate for low risk listed medicines that are not assessed pre-market.
Sponsors will still be required to hold suitable evidence to substantiate their permitted indications prior to listing.
The TGA has published a Draft List of Permitted Indications along with a list of associated evidence qualifiers. The draft will be available on the TGA website until 31 October 2017. During this period, you can provide feedback on the list and propose additional indications or evidence qualifiers prior to the lists being finalised.
From 31 October to 15 December 2017, the TGA will review proposals and finalise the legislative instruments.
Permitted indications reform comes into effect 1 January 2018. All existing indications must be updated from this point on, with sponsors having a 3-year transition period to comply. There is an 18 month period from 1 January 2018 to 30 June 2019 whereby sponsors will not incur a fee from the TGA to amend their current indications. After such time, sponsors will be subject to an application fee for listing compliance. The transition for existing listed medicine ends on 1 January 2021, at which stage all listed medicines must only contain permitted indications stipulated by this reform. Products that have not been updated as of that date, will be cancelled from the ARTG.
Advanced Wellness Regulatory Solutions will be providing a list of additional indications and evidence qualifier to the TGA for consideration by the due date, however if you have any indications or qualifiers that you would like to add to the list for considerations you may send them through to us to lodge as part of our submission or alternatively you can lodge them with the TGA (firstname.lastname@example.org). If you would like to us to lodge any indications on your behalf please email the indications with the following subject heading “Proposals for new indications and new evidence qualifiers” to email@example.com
In addition, there will be the introduction of a new medicine pathway. This new pathway will allow sponsors to apply for indications that fall outside the permitted indications list, but which are still appropriate for listed medicinal products (‘intermediate level’ indications) and have acceptable scientific evidence to support the proposed indications, which will be assessed prior to marketing by the TGA. The applications for indications in the new pathway will come at an extra cost and require higher level evidence than required for listed medicines.
For more information relating to reforms to the regulatory framework for complementary medicines, please refer to the TGA website.