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Use this form to seek TGA advice on a biowaiver justification proposed for inclusion in an application to register a new medicine for oral ingestion.
Requests for advice are limited to the following types of justifications:
- Biopharmaceutic Classification System (BCS)-based biowaiver justification
- Additional strength biowaiver justification
- Justification for use of an overseas reference product in a bioequivalence study.
This is an optional service, operating independently from the process of applying for registration of a medicine.
Based on the data submitted with this request, we will advise whether the proposed justification is acceptable and a biowaiver is appropriate for the medicine.
Further information about this process is at Early scientific advice.