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

Challenges in the implementation of EAACI guidelines on allergen immunotherapy: a global perspective on the regulation of allergen products
Challenges in the implementation of EAACI guidelines on allergen immunotherapy: a global perspective on the regulation of allergen products
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 by either obtaining a marketing authorisation or by being distributed as named patient products. Exemptions from marketing authorisations 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.
0105-4538
Bonertz, A.
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Roberts, G.C.
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Timon, M.
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Slater, J.
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Goldstein, J.
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Fernandez-Rivas, M.
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Muraro, A.
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Vieths, S.
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Bonertz, A.
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Timon, M.
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Slater, J.
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Goldstein, J.
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Barber, D.
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Palomares, O.
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Sheikh, A.
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Pawankar, R.
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Klimek, L.
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Angier, E.
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Casale, T.
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Lau, S.
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Sturm, G.
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Maria Varga, E.
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Gerth van Wijk, R.
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Bonini, S.
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Muraro, A.
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Vieths, S.
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Bonertz, A., Roberts, G.C., Hoefnagel, M., Timon, M., Slater, J., Rabin, R., Bridgewater, J., Pini, C., Pfaar, O., Akdis, C., Goldstein, J., Poulsen, L.K., Van Ree, R., Rhyner, Claudio, Barber, D., Palomares, O., Sheikh, A., Pawankar, R., Hamerlijnk, D., Klimek, L., Agache, I., Angier, E., Casale, T., Fernandez-Rivas, M., Halken, S., Jutel, M., Lau, S., Pajno, G., Sturm, G., Maria Varga, E., Gerth van Wijk, R., Bonini, S., Muraro, A. and Vieths, S. (2017) Challenges in the implementation of EAACI guidelines on allergen immunotherapy: a global perspective on the regulation of allergen products. Allergy. (doi:10.1111/all.13266).

Record type: Article

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 by either obtaining a marketing authorisation or by being distributed as named patient products. Exemptions from marketing authorisations 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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Accepted/In Press date: 29 July 2017
e-pub ahead of print date: 30 August 2017

Identifiers

Local EPrints ID: 413389
URI: http://eprints.soton.ac.uk/id/eprint/413389
ISSN: 0105-4538
PURE UUID: 04cf7403-89d3-41c4-a218-7b90d0350b49

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Date deposited: 23 Aug 2017 16:31
Last modified: 17 Dec 2019 05:57

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Contributors

Author: A. Bonertz
Author: G.C. Roberts
Author: M. Hoefnagel
Author: M. Timon
Author: J. Slater
Author: R. Rabin
Author: J. Bridgewater
Author: C. Pini
Author: O. Pfaar
Author: C. Akdis
Author: J. Goldstein
Author: L.K. Poulsen
Author: R. Van Ree
Author: Claudio Rhyner
Author: D. Barber
Author: O. Palomares
Author: A. Sheikh
Author: R. Pawankar
Author: D. Hamerlijnk
Author: L. Klimek
Author: I. Agache
Author: E. Angier
Author: T. Casale
Author: M. Fernandez-Rivas
Author: S. Halken
Author: M. Jutel
Author: S. Lau
Author: G. Pajno
Author: G. Sturm
Author: E. Maria Varga
Author: R. Gerth van Wijk
Author: S. Bonini
Author: A. Muraro
Author: S. Vieths

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