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).
Regulations 16GH and 16GI of the Therapeutic Goods Regulations 1990 provide legislated timeframes for the evaluation of applications for registered complementary medicines, assessed listed medicines and substances for use in listed medicines. The evaluation phase timeframe varies depending on the application category selected and the extent to which the COB report removes the need for the TGA to evaluate data. Timeframes associated with the different application types vary as follows:
Total Evaluation time (days)
Sole use of COB reports and/or monograph from a default standard
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.