EMA-consultatie: conceptdocument over een richtlijn voor de ontwikkeling van allergeenproducten in gematigde tot lage studiepopulaties
The European Medicines Agency has released a concept paper on a guideline for allergen products development in moderate to low-sized study populations.
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 European Union.
The concept paper is available by clicking here.
Comments should be provided using this template and sent to RIWPSecretariat@ema.europa.eu by 30 June 2019.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).