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.
journal_name
Allergyjournal_title
Allergyauthors
Bonertz A,Roberts GC,Hoefnagel M,Timon M,Slater JE,Rabin RL,Bridgewater J,Pini C,Pfaar O,Akdis C,Goldstein J,Poulsen LK,van Ree R,Rhyner C,Barber D,Palomares O,Sheikh A,Pawankar R,Hamerlijnk D,Klimek L,Agache I,doi
10.1111/all.13266subject
Has Abstractpub_date
2018-01-01 00:00:00pages
64-76issue
1eissn
0105-4538issn
1398-9995journal_volume
73pub_type
杂志文章,评审相关文献
ALLERGY文献大全abstract:BACKGROUND:Up to 10% of the patients in whom suspected betalactam hypersensitivity (HS) has been excluded by skin and challenge tests report suspected allergic reactions during subsequent treatments with the same or very similar betalactams. It has been suggested that the reactions may result from a resensitization ind...
journal_title:Allergy
pub_type: 临床试验,杂志文章
doi:10.1111/j.1398-9995.2006.01246.x
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:Multiple drug hypersensitivity syndrome (MDH) is used to describe persons with a drug hypersensitivity reaction (DHR) to at least two chemically unrelated drugs, confirmed by skin test or in vitro assay. METHODS:Medical records of 25 patients with MDH, tested and confirmed at our allergy division, were retr...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/all.14146
更新日期:2020-05-01 00:00:00
abstract::The standard treatment of allergic rhinitis and asthma consists of topical corticosteroids administered intranasally and inhaled through the mouth. Although this therapy is highly effective, and side-effects are few and mild, it may be possible further to improve the therapeutic index and patient compliance with the t...
journal_title:Allergy
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1398-9995.1998.tb03909.x
更新日期:1998-04-01 00:00:00
abstract::A two-site immunometric assay based on monoclonal antibodies (mAb) was developed for the measurement of a 20-kDa major allergen of cow. The sensitivity of this assay was (BDA20) 1 ng/ml. It was used to measure airborne allergen concentrations in 10 Finnish cowsheds. The mean concentration of the BDA20 measured at two ...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/j.1398-9995.1994.tb02091.x
更新日期:1994-10-01 00:00:00
abstract::Drug-induced erythema multiforme is reported with many antimicrobial and antipyretic medications. We present one patient who experienced erythema multiforme and urticaria after administration of pyrazinamide for treatment of cutaneous tuberculosis. The side-effects of pyrazinamide include hepatic or dermatologic disor...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/j.1398-9995.1996.tb04620.x
更新日期:1996-05-01 00:00:00
abstract:BACKGROUND:Levels of n-3 polyunsaturated fatty acids (PUFAs) and n-6 PUFAs in breast milk are associated with the development of allergic diseases up to school age. However, it is unknown whether this relationship persists when the child becomes older. We therefore studied the association between levels of n-3 PUFAs an...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/all.12703
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:The complex pathogenesis of atopic dermatitis (AD) is guided by cell surface receptor-mediated signal transduction regulated in lipid rafts. Miltefosine is a raft-modulating molecule targeting cell membranes. With this controlled clinical study, the clinical and immunomodulatory efficacy of miltefosine was i...
journal_title:Allergy
pub_type: 杂志文章,随机对照试验
doi:10.1111/j.1398-9995.2010.02341.x
更新日期:2010-09-01 00:00:00
abstract::This guideline is the result of a consensus reached during a panel discussion at the 2nd International Consensus Meeting on Urticaria, Urticaria 2004, a joint initiative of the European Academy of Allergology and Clinical Immunology Dermatology Section and the European Union (EU)-funded network of excellence, GA2LEN. ...
journal_title:Allergy
pub_type: 杂志文章,实务指引,评审
doi:10.1111/j.1398-9995.2005.00964.x
更新日期:2006-03-01 00:00:00
abstract::Airway remodeling is a central feature of asthma. It is exemplified by thickening of the lamina reticularis and structural changes to the epithelium, submucosa, smooth muscle, and vasculature of the airway wall. Airway remodeling may result from persistent airway inflammation. Immunoglobulin E (IgE) is an important me...
journal_title:Allergy
pub_type: 杂志文章,评审
doi:10.1111/j.1398-9995.2011.02617.x
更新日期:2011-09-01 00:00:00
abstract::Pharmacologic intervention in the management of allergic conjunctivitis was evaluated with different topical ocular agents in man. Their effect can be precisely assessed with the conjunctival provocation test (CPT). A potent specific H1-receptor antagonist, 0.05% mequitazine eye-drops, was tested in a double-blind ran...
journal_title:Allergy
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1398-9995.1997.tb01028.x
更新日期:1997-04-01 00:00:00
abstract::We investigated the proliferative response of lymphocytes from mite-sensitive patients (RAST D.far greater than 3.5 PRU/ml) in the presence of the major allergen Der.f.I purified from Dermatophagoides farinae. Comparative studies were carried out with peripheral blood mononuclear cells from non-atopic donors (RAST = 0...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/j.1398-9995.1988.tb00409.x
更新日期:1988-02-01 00:00:00
abstract:BACKGROUND:Genomewide association and epigenetic studies found a region within the RAD50 gene on chromosome 5q31 to be associated with total serum IgE levels and asthma. In mice, this region harbors a locus control region for nearby TH 2 cytokines, which is characterized by four Rad50 DNase I hypersensitive sites (RHS4...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/all.12450
更新日期:2014-09-01 00:00:00
abstract::Basophil histamine release by P. aeruginosa standard antigen was examined in cystic fibrosis patients chronically infected with mucoid P. aeruginosa (CF +P) and with pronounced antibody response against these bacteria, and in patients without P. aeruginosa infection (CF +P). All the patients showed eosinophil counts a...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/j.1398-9995.1980.tb01713.x
更新日期:1980-01-01 00:00:00
abstract::Viruses cause asthmatic exacerbations in schoolchildren. We tested the hypothesis that children who wheezed with viral respiratory tract infections secrete higher levels of the type 1 cytokine interferon-gamma (IFN-gamma) in the peripheral circulation than children who had never wheezed. Blood was taken from 13 childr...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1034/j.1398-9995.2000.00222.x
更新日期:2000-01-01 00:00:00
abstract::Although studies of families, inbred populations and twins have established that asthma has a hereditary basis, little evidence has shown that intrinsic asthma has an increased familial occurrence. To document this issue, we compared the prevalence of asthma in families of intrinsic asthmatics, extrinsic asthmatics an...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/j.1398-9995.1991.tb00600.x
更新日期:1991-07-01 00:00:00
abstract::Food allergies have become a significant heath burden as prevalence continues to rise, affecting 6%-13% of the global population. In the absence of drugs approved by regulatory agencies, the current standard of care remains avoidance of allergenic foods and management of acute allergic reactions with antihistamines an...
journal_title:Allergy
pub_type: 杂志文章,评审
doi:10.1111/all.14116
更新日期:2020-06-01 00:00:00
abstract:BACKGROUND:Hereditary angioedema (HAE), type I and II, is an autosomal dominant disease with deficiency of functional C1 inhibitor protein causing episodic swellings of skin, mucosa and viscera. HAE is a genetically heterogeneous disease with more than 200 different mutations in the SERPING1 gene. A genotype-phenotype ...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/j.1398-9995.2010.02456.x
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND:The purpose of this study was to assess the occurrence of immunoglobulin E sensitization to common environmental allergens (atopy) and new allergic diseases among schoolchildren after starting school in a water-damaged school building. The staff and pupils of a Finnish elementary school with visible water da...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1034/j.1398-9995.2001.056002175.x
更新日期:2001-02-01 00:00:00
abstract:BACKGROUND:Food allergy affects approximately 5% of children and is the leading cause of hospitalization for anaphylactic reactions in westernized countries. The mucosal adjuvant cholera toxin induces allergic sensitization to co-administered proteins in mice, while feeding the protein alone induces oral tolerance. Int...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/j.1398-9995.2010.02479.x
更新日期:2011-03-01 00:00:00
abstract::Allergic bronchopulmonary aspergillosis (ABPA) occurs in nonimmunocompromised patients and belongs to the hypersensitivity disorders induced by Aspergillus. Genetic factors and activation of bronchial epithelial cells in asthma or cystic fibrosis are responsible for the development of a CD(4)+Th2 lymphocyte activation...
journal_title:Allergy
pub_type: 杂志文章,评审
doi:10.1111/j.1398-9995.2005.00887.x
更新日期:2005-08-01 00:00:00
abstract::The increase in prevalence and burden of atopic diseases, i.e. eczema, rhinitis, and asthma over the past decades was paralleled by a worldwide increase in attention-deficit/hyperactivity disorder (ADHD) diagnoses. We systematically reviewed epidemiologic studies investigating the relationship between atopic diseases ...
journal_title:Allergy
pub_type: 杂志文章,评审
doi:10.1111/j.1398-9995.2010.02449.x
更新日期:2010-12-01 00:00:00
abstract:BACKGROUND:IgE-independent (pseudoallergic) reactions to food and food ingredients are common in a subgroup of adult patients with chronic urticaria, who have daily spontaneous occurrence of wheals. However, for children with chronic urticaria (duration longer than 6 weeks, no physical influence), no data on the import...
journal_title:Allergy
pub_type: 临床试验,杂志文章
doi:10.1111/j.1398-9995.1998.tb03817.x
更新日期:1998-11-01 00:00:00
abstract:BACKGROUND:Immunoglobulin E (IgE)-mediated allergy belongs to common chronic disorders resulting from an interaction between both genetic and environmental factors. The gene encoding CD14 is a positional candidate gene for allergic diseases as it is localized on chromosome 5q31.1, a region that is linked to asthma and ...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1034/j.1398-9995.2003.00271.x
更新日期:2003-10-01 00:00:00
abstract:BACKGROUND:Type-I-allergy to natural rubber latex (NRL) has been shown to be more prevalent among certain groups of patients. Children suffering from chronic renal failure (CRF) could be a suspected risk group because of their intense exposure to latex through catheters, gloves and anesthetic equipment during frequent ...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/j.1398-9995.2004.00503.x
更新日期:2004-07-01 00:00:00
abstract:BACKGROUND:Mustard IgE-mediated allergy is supposed to be a rare cause of food allergy, and its clinical features and cross-reactivities have not been fully elucidated. METHODS:A prospective study was carried out, recruiting mustard allergic patients, and paired control subjects. A clinical questionnaire was administe...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/j.1398-9995.2005.00644.x
更新日期:2005-01-01 00:00:00
abstract:RATIONALE:Nasal allergen provocations may be useful in investigating the pathophysiology of allergic rhinitis and effects of treatments. OBJECTIVE:To use grass pollen nasal allergen challenge (NAC) to investigate the effects of allergen immunotherapy in a cross-sectional study. METHODS:We studied nasal and cutaneous ...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/all.12608
更新日期:2015-06-01 00:00:00
abstract::We describe a case of contact allergic sensitization to budesonide in a nasal spray used in the treatment of allergic rhinitis. No cross-sensitivity to other topical corticosteroids was found. ...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/j.1398-9995.1992.tb02392.x
更新日期:1992-12-01 00:00:00
abstract::A total of 109 subjects reporting symptoms indicating type I hypersensitivity reactions to natural rubber latex (NRL) gloves was included in this study, and 66 of them had latex-specific IgE antibodies. They underwent provocation tests by wearing two types of NRL gloves with high (n=103) and low (n=75) allergen conten...
journal_title:Allergy
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1398-9995.1998.tb03920.x
更新日期:1998-04-01 00:00:00
abstract:BACKGROUND:Allergy diagnosis by determination of allergen-specific IgE is complicated by clinically irrelevant IgE, of which the most prominent example is IgE against cross-reactive carbohydrate determinants (CCDs) that occur on allergens from plants and insects. Therefore, CCDs cause numerous false-positive results. I...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/all.12229
更新日期:2013-10-01 00:00:00
abstract::Olea europaea (olive) pollen extract was prepared by aqueous extraction and characterized by biochemical and immunochemical methods. Two components, displaying respective mol. wt. of 17,000 and 19,000, were the most reactive allergens, being the doublet (designated Ole e I) recognized by most sera tested. The 19,000 m...
journal_title:Allergy
pub_type: 杂志文章
doi:10.1111/j.1398-9995.1993.tb00724.x
更新日期:1993-05-01 00:00:00