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Updated: Feb 19, 2026

Humanized Mediator Release Assay as a Read-Out for Allergen Potency
Published on: June 29, 2021
Proposals for harmonization of allergens regulation in the European Union
1Biological Products, Advanced Therapies and Biotechnology Division, Agencia Española de Medicamentos y Productos Sanitarios, Campezo 1, 28022 Madrid, Spain.
Abstract:
Allergen medicinal products in the European Union are regulated differently across the different Member States. Thus, whereas in some countries strict quality, safety and efficacy requirements are in place, in others, most allergens are on the market as Named Patient Products, without any regulatory oversight. This situation results on European allergic patients being exposed to totally different standards depending on where they live. Initiatives to correct this situation are needed.
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