The TGA has extended the market exclusivity period for eligible new ingredients used in listed medicines from 2 to 3 years from 9 November 2026.
Market exclusivity is intended to recognise the resources invested by applicants in researching and developing new ingredients for use in listed medicines. During the market exclusivity period, a protected ingredient can only be used in listed medicines by the ingredient owner and other sponsors authorised by the ingredient owner.
The change provides successful applicants who opt in to market exclusivity with an additional year of exclusive use of their newly approved ingredient. The exclusivity period starts from the date the ingredient is included in the Therapeutic Goods (Permissible Ingredients) Determination and ends 3 calendar years later.
The change follows feedback from industry that the previous 2-year period may not provide sufficient time to support product development and market entry following approval of a new ingredient.
To reflect the change, the TGA has updated the guidance Understanding the application requirements for a new substance in listed medicines and Understanding the regulation of therapeutic sunscreens.
With effect from 9 November 2026, applications for new substances for use in listed medicines will be eligible for a 3-year market exclusivity period, provided that the proposed ingredient is eligible for exclusivity.
