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Comparable overseas regulators (CORs): Requirements for indications
COR report-based process
Criterion 5 of the COR criteria states that indications for the medicine proposed for supply in Australia must be equivalent to that approved by the COR.
Criterion 5 also states that broadly similar population demographics, disease profiles, and expectations regarding public health outcomes should apply to both Australia and the overseas jurisdiction.
We understand that between countries:
- indications may differ in the way they are reflected in the local clinical practice, even where they are based on the same clinical data set
- indications may differ because of different clinical needs in different geographic areas
- for generics and biosimilars, the indications will be dictated by the indication of the originator product in each respective country. There is no guarantee that these are currently aligned across countries.
For COR report-based applications indications must be equivalent, but not necessarily identical. Acceptable differences between the approved and proposed indication are limited to minor changes in the wording or minor differences in expression, as long as the text describes the same:
- dosing range
- patient population and outcome
For generics and biosimilars, the proposed indication must be identical to the indication approved for the originator within Australia.
TGA has adopted the EMA guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data (CPMP/ICH/289/95 ICH Topic E 5 (R1) Note for Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data).