Purpose of review: Key aspects and outcomes from the recently published guidance on the regulation of allergen products are summarized.
Recent findings: A new regulatory guideline has been published to enhance harmonized national approaches on the regulation of allergen products and thereby strengthen the availability of high-quality products across the European Union (EU). As the guideline was developed, critical aspects for allergen products regulation were identified and are discussed in the document, including recommendations on the regulatory procedures to be applied for diagnostics, allergen immunotherapy products and named-patient products.
Summary: The new guidance is expected to provide clarifications on and support harmonization of the regulation of allergen products in the EU.