Assessed listed medicines

The TGA has implemented a new 'assessed listed medicines' pathway for sponsors to enter their products in the Australia Register of Therapeutic Goods (ARTG).

Medicines listed through the assessed listed medicines pathway will be included in the ARTG following self-certification of the safety and quality of the product, and TGA pre-market assessment of efficacy evidence supporting the proposed indications. An interactive decision tree has been developed to assist sponsors in determining which pathway is most suitable for their product

Background

In response to the Medicines and Medical Devices Regulation (MMDR) review, the Government accepted a recommendation to implement a third pathway for sponsors of complementary medicines to enter products in the ARTG. The 'assessed listed medicines' pathway sits between the current listed (lower risk) and registered (higher risk) pathways.

In February 2017 the TGA released a consultation paper: Reforms to the regulatory framework for complementary medicines: Assessment pathways and sought comments on the design and implementation of the assessed listed medicines pathway. A response has since been published on the TGA website.

What do I do now?

You can navigate through the guidance materials and decision tree from this web page to determine if you have a product that is eligible for listing through the new assessed listed medicine pathway and whether your product would meet the regulatory requirements. Sponsors are encouraged to request a pre-submission meeting with the TGA to ensure that they are aware of the legislative requirements for the new pathway and the data required for an application to be accepted for assessment. If it is determined at the meeting that the proposed data dossier is likely to be critically deficient, sponsors have the opportunity to address these deficiencies prior to submitting their application.

If you believe that you have an existing medicine listed in the ARTG that is eligible for transition to the assessed listed pathway you can refer to information on transitional arrangements for existing listed medicines below.

Assessed listed medicines evidence guidelines have been developed to assist applicants to understand the regulatory requirements. You are advised to review these guidelines when preparing an application for an assessed listed medicine.

The TGA has also compiled a list of frequently asked questions (FAQs) which you can refer to for further information.

Three ARTG entry pathways

Introduction of the assessed listed medicines pathway creates three ARTG entry pathways for complementary medicines which will ensure that there is a balance between ensuring adequate consumer protections are in place while better aligning regulatory effort with risk.

The introduction of the assessed listed medicines pathway:

• Broadens the scope of the listing framework to allow access to higher level indications than those on the list of permitted indications (i.e. claims relating to unhealthy populations) and indications that make reference to a serious form of disease (restricted representations).
• Encourages industry to improve the standard of evidence regarding the efficacy of complementary medicines.
• Bridges the significant gap that exists for industry between the existing listed and registered medicines pathways.

This will allow greater consumer access to a wider range of evidence-based remedies to self-manage their health.

See the three-tiered risk-based framework for complementary medicines fact sheet for more information.

Eligible products

Assessed listed medicines have the same eligibility requirements as the existing listed medicines pathway except for the level of indications they are able to use. Assessed listed medicines may use 'intermediate level indications' following the assessment of efficacy evidence.

See the assessed listed medicines fact sheet for more information.

Examples of suitable indications

Assessed listed medicines may use intermediate level indications following the assessment of efficacy evidence.

Regulatory requirements

Medicines listed through the assessed listed medicines pathway will be included in the ARTG following self-certification by the applicant of the safety and quality of the product, and TGA assessment of the efficacy evidence supporting the proposed indications.

If the TGA determines that the efficacy of the proposed medicine is well supported by the evidence provided, and the product meets all other requirements for listed medicines, it will be listed in the ARTG.

More information on the regulatory requirements for assessed listed medicines are set out in the three-tiered risk-based framework for complementary medicines fact sheet.

Evidence requirements

Assessment of efficacy data will be based on the finished product (rather than active ingredients in isolation) and include a detailed evaluation of evidence to support all intermediate and permitted indications. Evidence to support any lower level indications will align to the evidence requirements for listed medicines as detailed in the Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines.

An initial version of the Assessed listed medicines evidence guidelines has been developed and is published on the TGA website. The evidence requirements and businesses processes have been refined throughout 2018 as TGA and industry stakeholders gain experience with the new pathway. The evidence guidelines will be finalised by 2019.

TGA assessed claim

Assessed listed and registered complementary medicines which have undergone successful pre-market assessment by the TGA will have the option to include a TGA assessed claim that the product has been assessed for efficacy on the product label. Further information about the implementation arrangements for the TGA assessed claim for assessed listed and registered complementary medicines is available on the TGA webpage.

Data protection scheme for assessed listed medicines

The Data Protection Scheme for listed assessed medicines provides sponsors with a 5-year protection period for the clinical trial efficacy information that supports a new intermediate indication for an existing L(A) medicine. Further information about the Data Protection Scheme for assessed listed medicines is available on the Data Protection Scheme for Assessed Listed medicines webpage.

Implementation of the assessed listed medicines pathway

• The assessed listed medicines pathway is being introduced alongside the permitted indications reform. Further information on the permitted indications reforms is on the TGA website.
• A three year transition period commenced on 5 March 2018 for existing listed medicines to be re-listed.
• During the transition period, sponsors of existing listed medicines will need to comply with the new provisions as follows:
  • Sponsors of existing listed products with low level indications will be required to transition their products to the new requirements by selecting appropriate indications exclusively from the list of permitted indications.
  • Existing listed products with intermediate indications, will be required to either, transition their products to the new assessed listed medicines pathway, or alternatively, choose low level indications from the permitted indications list.
• New products that meet the eligibility requirements for listed medicines and make intermediate level indications must be listed through the new assessed listed medicines pathway.
• The first 12 months of the assessed listed medicines pathway will be used as an 'implementation phase' where the TGA will work closely with sponsors to ensure the processes, requirements and timeframes for the new pathway are appropriate.

Timeframes for implementation

The proposed transition plan will involve the following key dates (subject to the necessary legislation being in place).

Contact details

• Email: complementary.medicine.reforms@health.gov.au
• Phone: 1800 020 653 (free call within Australia) or +61 2 6232 8634