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