Early scientific advice request form

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.

Form

How to access a pdf or Word document

• Request for early scientific advice (pdf,92kb)
• Request for early scientific advice (docx,124kb)