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Diagnostic test allergens used for in vivo diagnosis of allergic diseases are at risk: a european perspective


Klimek, L; Hoffmann, H J; Renz, H; Demoly, P; Werfel, T; Matricardi, P M; Muraro, A; Schmid-Grendelmeier, P; Cardona, V; Papadopoulos, N G (2015). Diagnostic test allergens used for in vivo diagnosis of allergic diseases are at risk: a european perspective. Allergy, 70(10):1329-1331.

Abstract

In the European Union (EU), allergens used for diagnostic tests (TAs) are defined as medicinal products and have to be registered by national authorities. The current situation is not homogeneous. Existing authorizations need to be kept in the market in some EU states, while others need complete new authorizations requiring clinical trials, quality assurance methods, stability studies, and periodic safety update reports. Allergen manufacturers argue that offering a comprehensive panel of TAs may be economically disastrous. Expenses for initiation and maintenance of TA authorizations far exceed their related revenues and manufacturers may be forced to significantly limit their allergen portfolios. The availability of a wide range of high-quality TAs is very important for in vivo diagnoses of IgE-mediated allergies. Increased regulatory demands induce costs that need to be covered by public health organizations or reimbursed by health insurance companies.

Abstract

In the European Union (EU), allergens used for diagnostic tests (TAs) are defined as medicinal products and have to be registered by national authorities. The current situation is not homogeneous. Existing authorizations need to be kept in the market in some EU states, while others need complete new authorizations requiring clinical trials, quality assurance methods, stability studies, and periodic safety update reports. Allergen manufacturers argue that offering a comprehensive panel of TAs may be economically disastrous. Expenses for initiation and maintenance of TA authorizations far exceed their related revenues and manufacturers may be forced to significantly limit their allergen portfolios. The availability of a wide range of high-quality TAs is very important for in vivo diagnoses of IgE-mediated allergies. Increased regulatory demands induce costs that need to be covered by public health organizations or reimbursed by health insurance companies.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Dermatology Clinic
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:22 June 2015
Deposited On:30 Sep 2015 15:38
Last Modified:09 Dec 2017 03:24
Publisher:Wiley-Blackwell Publishing, Inc.
ISSN:0105-4538
Additional Information:This is the peer reviewed version of the following article: [Klimek L, Hoffmann HJ, Renz H, Demoly P, Werfel T, Matricardi PM, Muraro A, Schmid-Grendelmeier P, Cardona V, Papadopoulos NG. Diagnostic test allergens used for in vivo diagnosis of allergic diseases are at risk: a European Perspective. Allergy 2015; 70: 1329–1331], which has been published in final form at [http://dx.doi.org/10.1111/all.12676]. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1111/all.12676
PubMed ID:26105127

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