Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products

The aim of this new guideline is to detail the data requirements for demonstrating therapeutic equivalence between nasal products containing the same active moiety (ies), as these are currently insufficiently covered in existing guidelines.

Keywords:  therapeutic equivalence (TE), nasal

Current version

Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products

Draft: consultation closedConsultation dates: 25/07/2024 to 31/01/2025Reference Number: EMA/CHMP/315603/2024Summary:

The aim of this new guideline is to detail the data requirements for demonstrating therapeutic equivalence between nasal products containing the same active moiety (ies), as these are currently insufficiently covered in existing guidelines.

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