Demonstration of therapeutic equivalence for nasal products - Scientific guideline

This guideline is intended as a complement to the "Guideline on the pharmaceutical quality of inhalation and nasal products" (EMEA/CHMP/QWP/49313/2005 rev. 1). It addresses the requirements for demonstration of therapeutic equivalence (TE) between nasally administered products containing the same active moiety(ies). Also addresses the requirements for demonstrating bioequivalence (BE) for systemically acting nasal products containing the same active moiety(ies) via BE studies and describes when these studies can be waived based on in vitro data.

Keywords:  nasal, equivalence

Current version

Draft guideline on the requirements for demonstrating therapeutic equivalence for nasal products

Draft: consultation open Consultation dates: 08/10/2026 to 28/02/2027 Reference Number: EMA/220888/2026 Summary:

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

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

Draft: consultation closed Consultation dates: 25/07/2024 to 31/01/2025 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.