Assessed listed medicines pathway: frequently asked questions

The assessed listed medicines pathway is a new listing pathway through which sponsors can apply to list a complementary medicine into the Australian Register of Therapeutic Goods (ARTG). The new assessed listed medicines pathway will sit between the existing listed (lower risk) and registered (higher risk) complementary medicines pathways. These products present an intermediate level of risk based on their indications and label claims.

The new assessed listed medicines pathway is being implemented in response to Recommendation 39 of the Review of Medicines and Medical Devices Regulation (MMDR).

The introduction of the assessed listed medicines pathway creates three pathways to enter a complementary medicine in the ARTG. This will increase flexibility for sponsors by aligning the level of assessment with the risk associated with intermediate risk complementary medicines.

Complementary medicines listed under the assessed listed medicines pathway will be different in that:

• The products are able to use higher level claims than standard listed medicines.
• Assessed listed medicines will be given an AUST L(A) number which must be displayed on the product label.
• Complementary medicines which undergo successful pre-market assessment, which includes registered complementary medicines and assessed listed medicines, will have the option to include a 'claimer' on the label (further information on claimers is in the FAQ's below).

Like other listed medicines, assessed listed medicines must only use ingredients included in the Permissible Ingredients Determination. To be consistent with the lower risk status of listed medicines, regulatory limits and requirements are placed on the use of certain ingredients. These are specified in the Permissible Ingredients Determination.

The assessed listed medicines pathway is available from 19 March 2018.

Implementation of the assessed listed medicines pathway for complementary medicines is a significant change to the complementary medicines regulatory framework for sponsors of complementary medicines and the TGA. A small scale pilot was initially considered to aid the TGA in ensuring the new pathway was workable and achievable for industry. However, following a high level of interest from sponsors, the TGA has made the assessed listed medicine pathway available to all applicants from 19 March 2018.

The first twelve months of operation of the new pathway will be used as an initial 'implementation phase'. During this phase the TGA will work closely with applicants during the application and evaluation stages to review and refine the evidence guidelines, administrative processes and timeframes.

Yes

Sponsors may apply for practitioner only products under the new listing pathway as long as they meet all relevant requirements. Specific labelling requirements (as set out in TGO 92 Standard for labels of non-prescription medicines) will continue to apply to practitioner only products.

There will be application and evaluation fees for assessed listed medicine applications. The proposed fee structure was described in the Consultation: Business process improvements supporting complementary medicines assessment pathways. These fees are described in the Therapeutic Goods Regulations and summarised in the Schedule of fees and charges on the TGA website.

Yes

We monitor the ongoing safety, quality and efficacy of therapeutic goods in the market through our post-market safety monitoring activities.

Medicines listed through the assessed listed medicines pathway will be included in the ARTG following self-certification by the sponsor of the safety and quality of the product, and following successful TGA assessment of the efficacy evidence supporting the proposed indications. As such, an assessed listed medicine may be selected for post-market compliance review while it remains in the ARTG to check its compliance against the regulatory requirements that are self-certified by the sponsor. Efficacy of the product will not be routinely reviewed post-market. Products may be randomly selected or targeted for review.

Regulatory decisions and notices for complementary medicines are published on the TGA website.

Products listed in the ARTG under the assessed listed pathway must have at least one intermediate level indication.

Intermediate level indications are indications that exceed the criteria relating to permitted indications but are not classed as high level indications. See the assessed listed medicines fact sheet for more information.

Assessed listed medicines may also contain one or more low level indications (permitted indications).

This depends on the restricted representation.

Those products which use restricted representations covered by a substance based advertising exemption are not required to transition to the assessed listed medicines pathway. The specific advertising exemptions are:

• Vitamin D
• Calcium
• Folic acid

The permitted indications list will contain indications to support these advertising exemptions. Note that products covered by the substance based advertising exemptions will be required to transition their products to comply with the new requirements for permitted indications.

Products with product based restricted representation approvals must transition to the assessed listed medicines pathway. The TGA will streamline the application process and evidence requirements for these medicines and there will be no re-evaluation of previously submitted data (however submission of this evidence may still be required during the transition period).

Sponsors of listed medicines with indications that are not on the permitted indications list have the following options:

• If the indication meets the criteria to be a permitted indication, an application to have the indication added to the permitted indications list can be made and the product can be re-listed through the standard listing pathway.
• If the indication does not meet the criteria to be a permitted indication, the indication can be removed, or an application to transition the product to become listed as an assessed listed medicine can be made.

More information about the permitted indications reform and the transitional arrangements is available on the TGA website.

Transitional arrangements specific to the assessed listed medicines pathway are addressed in the questions below.

No.

The intended purpose of the assessed listed medicines pathway is not to assess complementary medicines that only make low level indications. Assessed listed complementary medicines must have at least one indication that is an intermediate level indication.

Yes.

Applications under the assessed listed medicines will involve an evaluation of efficacy. Sponsors must provide the required data and a draft label for the product which is assessed before the product can be listed. Sponsors will self-assess and certify that the application meets the quality and safety standards for listed complementary medicines.

Only products supported by quality scientific evidence (not evidence of tradition of use only) will be accepted for pre-market assessment. The assessment will include a detailed evaluation of evidence to support proposed intermediate level indications and any lower level indications to determine if the data supplied adequately supports those indications. The Assessed listed medicines evidence guidelines and evidence dossier requirements have been developed to assist applicants to understand the regulatory requirements.

It is proposed that complementary medicines that undergo pre-market assessment (the assessed listed medicines pathway and registered complementary medicines) will have the option to include a 'claimer' on the promotional material to indicate that the efficacy of the medicine has been independently reviewed by the TGA. Use of the claimer will be optional.

The 'claimer' is currently being developed. Further consultation on the implementation of the claimer is planned in early 2018 before its finalisation and availability for sponsors.

No.

Sponsors of listed medicines are not eligible to claim that the products have been assessed for efficacy, and cannot utilise a label claimer, following the completion of a listed medicines post-market compliance review. The assessed listed medicines pathway requires an application and pre-market assessment.

Your listed complementary medicine will need to transition to the assessed listed medicines pathway if your product has intermediate level indications that are not included in the list of permitted indications, and you intend to continue using these indications.

Note that alternatively, if these indications fit the criteria to be a permitted indication a sponsor can apply to have the indication added to the permitted indications list. A fee will apply.

There will be a three year transition period for existing listed medicines to be re-listed through the existing listing pathway or the new assessed listed medicines pathway.

Sponsors of existing listed medicines with intermediate indications will be able to apply to have the medicine re-listed through the assessed listed medicines pathway (with efficacy assessment) from March 2018.