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

Guidance explaining how the Comparable Overseas Bodies report-based process is associated with shortened evaluation timeframes for applications.

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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).

Legislation

Timeframes and milestones

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 categoryApplication typeScreening (days)Total Evaluation time (days)
IN1Sole use of COB reports and/or monograph from a default standard4070
IN2Mixed evaluation40120
IN3Mixed evaluation40150
IN4Full independent evaluation40180
L(A)2Sole use of COB reports4060
L(A)3Full independent evaluation40150
RCM2Sole use of COB reports4064
RCM3Mixed evaluation40150
RCM4Mixed evaluation40170
RCM5Full independent evaluation40210
Product types

Page history

Show all page updates (3)

Title changed from 'Timeframes and milestones' to 'Understanding timeframes for evaluating registered complementary medicines, assessed listed medicines and new ingredients applications ' as part of migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • Updated page summaries.
  • Complex images include long descriptions.
  • New ‘Save as PDF’ feature.

Minor update to table. 

Original publication. 

Title changed from 'Timeframes and milestones' to 'Understanding timeframes for evaluating registered complementary medicines, assessed listed medicines and new ingredients applications ' as part of migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • Updated page summaries.
  • Complex images include long descriptions.
  • New ‘Save as PDF’ feature.

Minor update to table. 

Original publication.