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.
HumanScientific guidelines

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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 closed Consultation dates: to Reference Number: EMA/CHMP/315603/2024 Summary:

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.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey support.

English (EN) (210.1 KB - PDF)

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