Understanding timeframes for the Comparable Overseas Bodies process for registered complementary medicines, assessed listed medicines and substances in listed medicines

Purpose

The COB report-based process is associated with shortened evaluation timeframes. The aim of this process is to:

• encourage harmonisation and sharing of knowledge
• reduce TGA duplication of evaluations undertaken by COBs, while still maintaining existing quality, safety and efficacy standards for medicines supplied in Australia
• allow applications following the COB report-based process to have shorter evaluation timeframes.

The intention is that the TGA will only need to evaluate data generated specifically for the Australian context (for example, Australian labels). However, in some instances, additional data may need to be considered (for example, to address data gaps or additional safety data generated since the COB evaluation report approval).