New guidance on the regulation of allergen products: key aspects and outcomes.

Abstract:

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.

authors

Bonertz A,Mahler V,Vieths S

doi

10.1097/ACI.0000000000000687

subject

Has Abstract

pub_date

2020-12-01 00:00:00

pages

624-630

issue

6

eissn

1528-4050

issn

1473-6322

pii

00130832-202012000-00012

journal_volume

20

pub_type

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