Intermediate Level – Listed Assessed Medicines
Reform recommendations for complementary medicines has seen the development of a three-tiered, risk-based framework for the regulation of CAM’s. The revised framework introduces a new (intermediate risk) assessment pathway sitting between the existing listed medicine (low risk) and registered medicine (high risk) pathways.
At present, listed complementary medicines are included in the Register on the basis of self-certification by the applicant, while the registration of complementary medicines requires evaluation by the TGA.
The introduction of a third pathway will allow sponsors to apply for indications that fall outside the permitted indications list, but which are still appropriate for listed medicine products (‘intermediate level’ indications). Applications for listed assessed medicines will be required to provide acceptable scientific evidence to support the proposed indications, which will be assessed prior to marketing by the TGA.
The new pathway allows medicines to be included in the Register following certification by the sponsor about the safety and quality of the product, and assessment by the Secretary of the efficacy evidence supporting the proposed indications, allowing sponsors to claim that their medicine has been assessed by the TGA for efficacy.
Applications for indications in the new pathway will require higher-level evidence than required for listed medicines under the current pathway. Fees for the new “listed assessed” intermediate pathway have been separated into 3 categories. For the first category, a combined application and evaluation fee of $2,070 has been set and for the second and third categories has been set at $15,160.
The application fee for the current listing pathway will remain at $800 for the 2017-2018 financial year and an annual charge of $1,020 will be incurred.