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
Contents
- 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
- Application framework
- 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
- COB checklists
- Gap analysis
- When is the dossier of information used to support a COB report required?
- Requirements specific to different application types
- Appendix
- Stage 1 Criteria: Establishing similarity between the COB and the TGA
Supporting documents
Guidance on using evaluation reports from Comparable Overseas Bodies
[PDF, 354.22 KB]