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Focus on Regulation

Tag Archives: allergic disease

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases

Introduction On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are currently applicable. They provide guidance for the clinical development and quality control of medicinal products containing allergens. All of these guidelines start