Where possible, the TGA uses evaluation reports from comparable overseas bodies (COBs) in the evaluation of applications for registered complementary medicines, assessed listed medicines and substances for use as ingredients in listed medicines.
This guidance provides:
an overview of the COB report-based process and application categories
criteria for the TGA's acceptance of COB evaluation reports
application submission requirements for the use of COB evaluation reports
criteria for establishing similarity between a COB and the TGA
Scope of guidance document
SECTION A - Overview of the COB report-based process
Purpose of the COB report-based process
Challenges in identifying suitable COB reports
Overview of the COB report-based application process
List of COBs for registered complementary medicines, assessed listed medicines and substances for use in listed medicines
Criteria for acceptance of COB evaluation reports
SECTION B - Submission requirements for the COB report-based process
When is the dossier of information used to support a COB report required?
Requirements specific to different application types
Stage 1 Criteria: Establishing similarity between the COB and the TGA
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.