Submissions received in response to the consultation showed broad stakeholder support for the proposed approaches to implement these reforms. However, some modifications were proposed, particularly in relation to the evidence requirements and protection of efficacy data for products assessed through the new listing pathway. We will continue to review implementation options to address these concerns.

Stakeholder feedback has informed our position going forward and the upcoming changes to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990. Changes resulting from the feedback are summarised in the Outcome Summary below noting further targeted feedback will be sought in some cases.

Further information on implementation arrangements and guidance documentation for reforms in this consultation will be included on the TGA website in the coming months.

Outcome summary

Summary of changes resulting from public consultation: Reforms to the regulatory framework for complementary medicines: Assessment pathways

Table 1: A new 'listing pathway' for complementary medicines
Current situation	Proposed change	Benefits
There is a two-tiered risk-based framework for the regulation of complementary medicines. Lower risk medicines are self-assessed by the sponsor and are listed on the ARTG without pre-market assessment. Products must: only contain permitted ingredients (safety) be manufactured in accordance with the principles of Good Manufacturing Practice (GMP) (quality) only make indications (for therapeutic use) for health maintenance and health enhancement or certain indications for non-serious, self-limiting conditions. Evidence of product effectiveness (efficacy) may be assessed by the TGA post-market. Higher risk medicines are registered on the ARTG following pre-market assessment of product quality, safety and efficacy.	There will be a three-tiered risk-based framework for the regulation of complementary medicines. A new listing pathway will be introduced that will sit between the current listed (lowest risk) and registered (higher risk) pathways. Medicines listed via the new pathway: must only contain permitted ingredients (safety) must be manufactured in accordance with the principles of GMP (quality) may make indications that fall outside the list of permitted indications but which are still appropriate for listed medicinal products. Eligibility criteria developed to allow medicines listed via the new pathway to make indications for: the alleviation or prevention of non-serious, self-limiting conditions and claims that refer to serious forms of a disease or condition (i.e. restricted representations). Medicines listed through the new pathway will be included in the ARTG following certification by the sponsor about the safety and quality of the product, and TGA assessment of the efficacy evidence supporting the proposed indications.	The three-tiered approach bridges the significant gap that exists for industry between the evidence requirements, costs and timeframes for the existing listed and registered medicines. There will be clear risk-based eligibility criteria for industry and consumers to differentiate between pathways. The scope of the listing framework will be broadened to allow access to higher level claims than are currently appropriate for listed medicines (i.e. claims relating to unhealthy populations). New restricted representation approvals relating to product indications will be streamlined within a single pre-market assessment process.

Table 2: Permitted indications for listed medicines
Current situation	Proposed change	Benefits
Sponsors can use a free-text field when entering therapeutic indications onto the ARTG.	The free-text field will be removed. Listed medicine sponsors will only be able to use indications from the permitted indications list. Sponsors will be able to apply for new indications to be added to the permitted indications list. Eligibility criteria developed to ensure that listed medicines can only make indications referring to: health maintenance health enhancement or certain indications for non-serious, self-limiting conditions.	Helps ensure that product sponsors do not overstate therapeutic benefits of their products. Increased transparency and reduced complexity for industry about the claims that are appropriate for listed medicines. Provides clearer requirements to industry to help prevent inadvertent non-compliance by product sponsors.

Table 3: Efficacy 'claimer' for pre-market assessed complementary medicine
Current situation	Proposed change	Benefits
Sponsors cannot currently make a claim that the TGA has reviewed / assessed the product's efficacy.	Sponsors of medicines that have undergone pre-market assessment for product efficacy (the new pathway and registered medicines) will have the option to include a claimer on the promotional material stating that the efficacy of the medicine has been independently reviewed. Further consultation on the implementation of this is planned.	Increased consumer awareness of the level of assessment undertaken by the TGA. More information to help consumers self-select products. Market advantage for sponsors who undertake high quality scientific evidence to support the product indications.

Table 4: Incentives for innovation
Current situation	Proposed change	Benefits
The current process for new ingredient applications does not protect the resources invested by innovators who research and develop new ingredients for use in complementary medicines.	A mechanism to allow for a 2 year market exclusivity period will be developed for new complementary medicine ingredients approved for use in listed medicines.	Incentive for industry to innovate and bring new products to market. Encourages research into emerging areas of complementary medicines.

Category:

Complementary medicines

Tags:

consultation submissions, regulatory reforms, regulatory frameworks

URL:

https://www.tga.gov.au/node/758929

Therapeutic Goods Administration (TGA)

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Submissions received and TGA response: Reforms to the regulatory framework for complementary medicines

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Outcome summary

Summary of changes resulting from public consultation: Reforms to the regulatory framework for complementary medicines: Assessment pathways

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