Concept paper on a guideline for allergen products development in moderate to low-sized study populations - Scientific guideline

This concept paper proposes the development of a scientific guideline for allergen products where adequate data according to existing guidelines cannot be reasonably obtained because the number of  patients available for the required clinical trials is too low and for which there is no distinct regulatory guidance currently available within the EU.

Keywords: allergen product, diagnosis, treatment, clinical development programme, quality control, guidance, moderate population, low-sized population

Current effective version

Concept paper on a guideline for allergen products development in moderate to low-sized study populations

Draft: consultation closed Consultation dates: 21/12/2018 to 30/06/2019 Reference Number: EMA/CHMP/251023/2018