Article open access publication

Challenges in the implementation of EAACI guidelines on allergen immunotherapy: A global perspective on the regulation of allergen products

Allergy, Wiley, ISSN 1398-9995

Volume 73, 1, 2018

DOI:10.1111/all.13266, Dimensions: pub.1090994648, PMID: 28771830,

Affiliations

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  1. (1) Paul‐Ehrlich‐Institut Langen Germany
  2. (2) David Hide Asthma and Allergy Research Centre Newport Isle of Wight UK
  3. (3) University Hospital Southampton NHS Foundation Trust, grid.430506.4
  4. (4) University of Southampton, grid.5491.9
  5. (5) CBG‐MEB (Medicines Evaluation Board) Utrecht The Netherlands
  6. (6) Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Division of Biological Products, Advanced Therapies and Biotechnology Madrid Spain
  7. (7) United States Food and Drug Administration, grid.417587.8
  8. (8) Istituto Superiore di Sanità, grid.416651.1
  9. (9) Universitätsmedizin Mannheim, Heidelberg University Department of Otorhinolaryngology, Head and Neck Surgery Mannheim Germany
  10. (10) Center for Rhinology and Allergology Wiesbaden Germany
  11. (11) University of Zurich, grid.7400.3
  12. (12) National Institutes of Health Division of Allergy, Immunology and Transplantation Bethesda MD USA
  13. (13) Gentofte Hospital, grid.411646.0, Capital Region
  14. (14) University of Amsterdam, grid.7177.6
  15. (15) SIAF Davos Switzerland
  16. (16) CEU San Pablo University, grid.8461.b
  17. (17) Complutense University of Madrid, grid.4795.f
  18. (18) University of Edinburgh, grid.4305.2
  19. (19) Nippon Medical School, grid.410821.e
  20. (20) Lung Foundation Netherlands, grid.483832.6
  21. (21) Transylvania University of Brașov, grid.5120.6
  22. (22) Sheffield Teaching Hospital Sheffield UK
  23. (23) University of South Florida, grid.170693.a
  24. (24) Hospital Clinico San Carlos, IdISSC Allergy Department Madrid Spain
  25. (25) Odense University Hospital, grid.7143.1, Southern Denmark Region
  26. (26) Wroclaw Medical University Poland and ALL‐MED Medical Research Institute Wrocław Poland
  27. (27) Wrocław Medical University, grid.4495.c
  28. (28) Charité, grid.6363.0
  29. (29) University of Messina, grid.10438.3e
  30. (30) Outpatient Allergy Clinic Reumannplatz Vienna Austria
  31. (31) Medical University of Graz, grid.11598.34
  32. (32) Erasmus MC Rotterdam The Netherlands
  33. (33) University of Campania "Luigi Vanvitelli", grid.9841.4
  34. (34) Azienda Ospedaliera di Padova, grid.411474.3

Description

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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Times Cited: 41

Field Citation Ratio (FCR): 13.34

Relative Citation ratio (RCR): 6.67

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