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Timeframes and milestones

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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:

Application category Application type Screening (days) Total Evaluation time (days)
IN1 Sole use of COB reports and/or monograph from a default standard 40 70
IN2 Mixed evaluation 40 120
IN3 Mixed evaluation 40 150
IN4 Full independent evaluation 40 180
L(A)2 Sole use of COB reports 40 60
L(A)3 Full independent evaluation 40 150
RCM2 Sole use of COB reports 40 64
RCM3 Mixed evaluation 40 150
RCM4 Mixed evaluation 40 170
RCM5 Full independent evaluation 40 210
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This webpage on the TGA website was printed on 18 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/timeframes-and-milestones

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