Challenges in the implementation of EAACI guidelines on allergen immunotherapy: A global perspective on the regulation of allergen products |
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| Authors: | A Bonertz G C Roberts M Hoefnagel M Timon J E Slater R L Rabin J Bridgewater C Pini O Pfaar C Akdis J Goldstein L K Poulsen R van Ree C Rhyner D Barber O Palomares A Sheikh R Pawankar D Hamerlijnk L Klimek I Agache E Angier T Casale M Fernandez‐Rivas S Halken M Jutel S Lau G Pajno G Sturm E M Varga R Gerth van Wijk S Bonini A Muraro S Vieths |
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| Institution: | 1. Paul‐Ehrlich‐Institut, Langen, Germany;2. University of Southampton, Southampton, UK;3. University Hospital Southampton NHS Foundation Trust, Southampton, UK;4. David Hide Asthma and Allergy Research Centre, Newport, Isle of Wight, UK;5. CBG‐MEB (Medicines Evaluation Board), Utrecht, The Netherlands;6. Division of Biological Products, Advanced Therapies and Biotechnology, Agencia Espa?ola de Medicamentos y Productos Sanitarios (AEMPS), Madrid, Spain;7. US Food and Drug Administration, Silver Spring, MD, USA;8. Istituto Superiore di Sanità, Rome, Italy;9. Department of Otorhinolaryngology, Head and Neck Surgery, Medical Faculty Mannheim, Universit?tsmedizin Mannheim, Heidelberg University, Mannheim, Germany;10. Center for Rhinology and Allergology, Wiesbaden, Germany;11. Swiss Institute of Allergy and Asthma Research, University Zurich, Davos, Switzerland;12. Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA;13. Allergy Clinic, Copenhagen University Hospital at Gentofte, Copenhagen, Denmark;14. Departments of Experimental Immunology and of Otorhinolaryngology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;15. SIAF, Davos, Switzerland;16. Universidad CEU San Pablo, Madrid, Spain;17. Department of Biochemistry and Molecular Biology, School of Chemistry, Complutense University of Madrid (UCM), Madrid, Spain;18. The University of Edinburgh, Scotland, UK;19. Nippon Medical School, Tokyo, Japan;20. Patient Advocacy Group, Dutch Lung Foundation, Amersfoort, The Netherlands;21. Department of Allergy and Clinical Immunology, Faculty of Medicine, Transylvania University Brasov, Brasov, Romania;22. Sheffield Teaching Hospital, Sheffield, UK;23. University of South Florida, Tampa, FL, USA;24. Allergy Department, Hospital Clinico San Carlos, IdISSC, Madrid, Spain;25. Hans Christian Andersen Childrens Hospital, Odense University Hospital, Odense, Denmark;26. Poland and ALL‐MED Medical Research Institute, Wroclaw Medical University, Wroc?aw, Poland;27. Department for Pediatric Pneumology and Immunology, Charité Universit?tsmedizin, Berlin, Germany;28. Department of Pediatrics and Allergy Unit, University of Messina, Messina, Italy;29. Department of Dermatology and Venerology, Medical University of Graz, Austria;30. Outpatient Allergy Clinic Reumannplatz, Vienna, Austria;31. Medical University of Graz, Graz, Austria;32. Erasmus MC, Rotterdam, The Netherlands;33. University of Campania Luigi Vanvitelli, IFT‐CNR, Naples, Rome, Italy;34. Padua University Hospital, Padua, Italy |
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| Abstract: | Regulatory approaches for allergen immunotherapy (AIT) products and the availability of high‐quality AIT products are inherently linked to each other. While allergen products are available in many countries across the globe, their regulation is very heterogeneous. First, we describe the regulatory systems applicable for AIT products in the European Union (EU) and in the United States (US). For Europe, a depiction of the different types of relevant procedures, as well as the committees involved, is provided and the fundamental role of national agencies of the EU member states in this complex and unique network is highlighted. Furthermore, the regulatory agencies from Australia, Canada, Japan, Russia, and Switzerland provided information on the system implemented in their countries for the regulation of allergen products. While AIT products are commonly classified as biological medicinal products, they are made available by varying types of procedures, most commonly either by obtaining a marketing authorization or by being distributed as named patient products. Exemptions from marketing authorizations in exceptional cases, as well as import of allergen products from other countries, are additional tools applied by countries to ensure availability of needed AIT products. Several challenges for AIT products are apparent from this analysis and will require further consideration. |
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| Keywords: | allergen immunotherapy allergic diseases allergy regulation |
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