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

被引：76

作者：

Bonertz, A. ^{[1
]}

Roberts, G. C. ^{[2
,3
,4
]}

Hoefnagel, M. ^{[5
]}

Timon, M. ^{[6
]}

Slater, J. E. ^{[7
]}

Rabin, R. L. ^{[7
]}

Bridgewater, J. ^{[7
]}

Pini, C. ^{[8
]}

Pfaar, O. ^{[9
,10
]}

Akdis, C. ^{[11
]}

Goldstein, J. ^{[12
]}

Poulsen, L. K. ^{[13
]}

van Ree, R. ^{[14
,15
]}

Rhyner, C. ^{[16
]}

Barber, D. ^{[17
]}

Palomares, O. ^{[18
]}

Sheikh, A. ^{[19
]}

Pawankar, R. ^{[20
]}

Hamerlijnk, D. ^{[21
]}

Klimek, L. ^{[10
]}

Agache, I. ^{[22
]}

Angier, E. ^{[23
]}

Casale, T. ^{[24
]}

Fernandez-Rivas, M. ^{[25
]}

Halken, S. ^{[26
]}

Jutel, M. ^{[27
]}

Lau, S. ^{[28
]}

Pajno, G. ^{[29
,30
]}

Sturm, G. ^{[31
,32
]}

Varga, E. M. ^{[33
]}

van Wijk, R. Gerth ^{[34
]}

Bonini, S. ^{[35
]}

Muraro, A. ^{[36
]}

Vieths, S. ^{[1
]}

机构：

[1] Paul Ehrlich Inst, Langen, Germany

[2] Univ Southampton, Southampton, Hants, England

[3] Univ Hosp Southampton NHS Fdn Trust, Southampton, Hants, England

[4] David Hide Asthma & Allergy Res Ctr, Newport, Wight, England

[5] CBG MEB Med Evaluat Board, Utrecht, Netherlands

[6] AEMPS, Div Biol Prod Adv Therapies & Biotechnol, Madrid, Spain

[7] US FDA, Silver Spring, MD USA

[8] Ist Super Sanita, Rome, Italy

[9] Heidelberg Univ, Univ Med Mannheim, Dept Otorhinolaryngol Head & Neck Surg, Med Fac Mannheim, Mannheim, Germany

[10] Ctr Rhinol & Allergol, Wiesbaden, Germany

[11] Univ Zurich, Swiss Inst Allergy & Asthma Res, Davos, Switzerland

[12] NIAID, Div Allergy Immunol & Transplantat, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA

[13] Univ Hosp Gentofte, Allergy Clin, Copenhagen, Denmark

[14] Univ Amsterdam, Acad Med Ctr, Dept Expt Immunol, Amsterdam, Netherlands

[15] Univ Amsterdam, Acad Med Ctr, Dept Otorhinolaryngol, Amsterdam, Netherlands

[16] SIAF, Davos, Switzerland

[17] Univ CEU San Pablo, Madrid, Spain

[18] Complutense Univ Madrid UCM, Dept Biochem & Mol Biol, Sch Chem, Madrid, Spain

[19] Univ Edinburgh, Edinburgh, Midlothian, Scotland

[20] Nippon Med Sch, Tokyo, Japan

[21] Dutch Lung Fdn, Patient Advocacy Grp, Amersfoort, Netherlands

[22] Transylvania Univ Brasov, Dept Allergy & Clin Immunol, Fac Med, Brasov, Romania

[23] Sheffield Teaching Hosp, Sheffield, S Yorkshire, England

[24] Univ S Florida, Tampa, FL USA

[25] Hosp Clin San Carlos, Dept Allergy, IdISSC, Madrid, Spain

[26] Odense Univ Hosp, Hans Christian Andersen Childrens Hosp, Odense, Denmark

[27] Wroclaw Med Univ, Poland & ALL MED Med Res Inst, Wroclaw, Poland

[28] Charite, Dept Pediat Pneumol & Immunol, Berlin, Germany

[29] Univ Messina, Dept Pediat, Messina, Italy

[30] Univ Messina, Allergy Unit, Messina, Italy

[31] Med Univ Graz, Dept Dermatol & Venerol, Graz, Austria

[32] Outpatient Allergy Clin Reumannpl, Vienna, Austria

[33] Med Univ Graz, Graz, Austria

[34] Erasmus MC, Rotterdam, Netherlands

[35] Univ Campania Luigi Vanvitelli, IFT CNR, Naples, Italy

[36] Padua Univ Hosp, Padua, Italy

来源：

ALLERGY | 2018年 / 73卷 / 01期

关键词：

allergen immunotherapy; allergic diseases; allergy; regulation; RHINITIS;

D O I：

10.1111/all.13266

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

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.

引用

页码：64 / 76

页数：13

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