Requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats - Scientific guideline

This document lays down the quality recommendations for allergen products of biological origin, including allergen extracts derived from natural source material and allergens produced through recombinant DNA technology, used for immunotherapy treatment (AIT: Allergen Immunotherapy treatment /SIT: Specific Immunotherapy treatment) or in vivo diagnosis of immunoglobulin E (IgE)-mediated allergic diseases in horses, dogs and cats. In addition, guidance is given for the clinical testing regarding safety and efficacy of allergen products.

Keywords: Allergen, veterinary

Current effective version

Guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats

Legal effective date: 13/01/2024Reference Number: EMA/CVMP/IWP/170689/2016

Document history

Guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats

Legal effective date: 13/01/2024Reference Number: EMA/CVMP/IWP/170689/2016

Overview of comments received on 'Draft guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats'

Reference Number: EMA/CVMP/IWP/530940/2019

Draft guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats - Revision 1

Consultation dates: 19/12/2018 to 31/08/2019Draft: consultation closedReference Number: EMA/CVMP/IWP/170689/2016Summary:

This Guideline lays down the quality recommendations for allergen products of biological origin, including allergen extracts derived from natural source material and allergens produced through recombinant DNA technology, used for treatment or specific immunotherapy (SIT) or in vivo diagnosis of immunoglobulin E (IgE)-mediated allergic diseases in horses, dogs and cats. In addition, guidance is given for the clinical testing regarding safety and efficacy of the products.

Draft concept paper on requirements for the production and control of allergen products for use in animals

Consultation dates: 18/09/2015 to 31/12/2015Draft: consultation closedReference Number: EMA/CVMP/IWP/351882/2015Summary:

Recent developments require the revision of the existing CVMP/IWP Guideline on allergen products. Since the revision of this guideline in 1994, the scientific knowledge on structures, cross-reactivity, and stability of allergens has increased drastically, and many allergens have been produced as recombinant proteins. This scientific progress has several implications for regulation and standardisation of allergen products. Special emphasis has to be granted to recombinant allergen products. Therefore, the revised guideline should redefine the statements on batch-to-batch consistency, characterisation and use of in house reference preparations (IHR), control test as well as on safety and efficacy testing. Moreover, it should be aimed at covering aspects specific for recombinant allergens that are not covered or specifically addressed by other guidelines on biotechnology-derived proteins.

Specific requirements for the production and control of allergen products

AdoptedLegal effective date: 01/09/1994Reference Number: 7BIm11a Volume 7