Overview of the COB-based process
- The COB process has been divided into 2 stages: criteria for identifying COBs (Stage 1) and criteria for accepting COB reports (Stage 2). Below is an overview of how the COBs included in the List of bodies or jurisdictions determined to be COBs for complementary and listed medicines were identified by TGA.
- Applicants can then use the Stage 2 Criteria for identifying COBs and accepting reports to determine if a particular COB evaluation report is suitable for a particular application. COB reports can then be included in an application along with the full submission dossier. See Submission requirements for COB reports for more information.
- During application screening, the TGA will confirm whether the application is eligible for the COB report-based process and that the correct application category has been selected.
- Depending on the quality and scope of the COB evaluation report(s) provided to the TGA, the TGA will not re-evaluate the data provided in the dossier that has been previously evaluated and approved by a COB. Where an applicant provides COB report(s) that meet all minimum data requirements, the TGA will only need to evaluate data generated specifically for the Australian context (for example: Australian labels or storage conditions). However, if any issues arise during TGA's review of the COB assessment report, the TGA will review the data provided in the dossier. 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).
It is the responsibility of the applicant to:
- obtain any relevant un-redacted COB evaluation reports, in English
- provide a justification for how the content of the COB evaluation report(s) meet the TGA's technical requirements, for example: the ARGCM, assessed listed medicines evidence guidelines and any other relevant technical regulatory guidelines
- undertake a gap analysis to address data gaps due to insufficient data
- undertake a gap analysis to account for any new information generated since the COB evaluation report was approved.
Where the submission requirements for COB reports are not met, the application must be resubmitted for independent evaluation through the appropriate application category.
The TGA will also accept evaluation reports from overseas bodies that are not included on the list of TGA-approved COBs as part of a full independent evaluation by the TGA (for example: IN4, L(A)3 and RCM5), provided the Stage 2 Criteria for accepting COB evaluation reports are met.