Allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations - Scientific guideline

This document provides guidance on the clinical development  for allergen products for immunotherapy and allergy diagnosis in moderate to low-sized study populations.

Keywords: Allergen, allergy, allergen immunotherapy, immune therapy, small population

Current version

Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to lowsized study populations

Adopted Reference Number: EMA/161669/2025 Legal effective date: 01/01/2026

Document history

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Draft: consultation closed Consultation dates: 28/02/2024 to 31/05/2024 Reference Number: EMA/CHMP/72790/2024