French application of the European guidelines for regulation of allergenic extracts

In patients with allergic rhinitis (AR), the nasal provocation test (NPT) is the standard procedure to evaluate the clinical response of the nasal mucosa to allergens with a high specificity and sensitivity. In AR, it is the only test that really measures the response of the diseased mucosa to allergens while skin prick test and serum IgE confirm the clinical suspicion of sensitization. Moreover, it is of special relevance in the detection of patients with Local Allergic Rhinitis (LAR), where general sensitization cannot be measured. For the evaluation of therapeutic interventions, NPT has been used for the clinical monitoring of antiallergic drugs and allergen specific immunotherapy. Legislation within the European Union (EU) defines allergens used for diagnostic tests like NPT to be medicinal products according to Directive 2001/83 EC, but national law is considering these products to be medicinal devices in a number of EU countries. Thus, NPT products are governed by different legislations and therefore standards throughout the EU. In consequence, allergens used for diagnostic purposes need different registrations and Marketing Authorization by national authorities. After a transition period, regulations of EU Directives are to be implemented in national law by all member states. At the moment, most EU countries have not fully implemented these Directives, however, it can be expected that most countries will implement it and enforce their rules within the next years. This development has a tremendous impact on the availability of diagnostic allergens for NPT in Europe and will make make nasal provocation testing very difficult if not impossible. We describe the current situation of diagnostic allergens under the special legislative conditions in the EU with special focus on allergen products used for NPT and the consequences for the diagnosis of AR and LAR.

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“…The regulation of TAs follows the European Pharmacopoeia and the European Medicines Agency (EMA) Guideline on allergen products (11,14,16,24) .…”

Section: Plication For Npt Test Allergensmentioning

confidence: 99%

The influence of European legislation on the use of diagnostic test allergens for nasal allergen provocation in routine care of patients with allergic rhinitis

Klimek¹,

Hammerbacher²,

Hellings³

et al. 2015

Rhin

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“…These approximations are analogous in concept to that proposed by CBER in the USA, but are generally more rigorous, and the number of allergen extracts permitted are fewer than those currently available in the USA. 32 …”

Section: In 2009mentioning

confidence: 99%

Considerations About Pollen Used for the Production of Allergen Extracts

Codina

Crenshaw²,

Lockey

2015

The Journal of Allergy and Clinical Immunology: In Practice

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How In Vitro Assays Contribute to Allergy Diagnosis

Casset

Khayath

Blay

2016

Curr Allergy Asthma Rep

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Diagnosis of allergic disorders is based upon the clinical history of the disease, the immunoglobulin E (IgE) antibody response, and the allergen exposure. During the last decade, many changes have occurred in the in vitro diagnostic tests used in daily practice. The most important one is the use of allergenic molecules, which helps to define severe profile of allergy and/or to better understand cross-reactivity. The correlation between IgE sensitization and bronchial or nasal response in provocation tests is not so clear, which implies that such tests are still helpful in allergy diagnosis. In order to strengthen the link between a real allergen exposure and allergic symptoms, environmental allergen load assessment can be performed. For clinicians, it appears obvious to know the pollen count to treat their patients; however, they rarely measure the allergen load in the indoor environment, while nowadays home-tests (semi-quantitative or quantitative) make the assessment very easy. In the future, assessment of the environmental exposure (preferably with an indoor technician) of an allergic patient should take into account not only the allergens but also the other indoor pollutants, which could enhance respiratory symptoms in allergic patients.

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French application of the European guidelines for regulation of allergenic extracts

Cited by 10 publications

References 4 publications

The influence of European legislation on the use of diagnostic test allergens for nasal allergen provocation in routine care of patients with allergic rhinitis

The influence of European legislation on the use of diagnostic test allergens for nasal allergen provocation in routine care of patients with allergic rhinitis

Considerations About Pollen Used for the Production of Allergen Extracts

How In Vitro Assays Contribute to Allergy Diagnosis

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