Increasing prevalence of allergies represents a major problem for healthcare systems across Europe. It is estimated by the World Allergy Organisation (WAO) that over 30% of the population suffers from some kind of allergy.
Currently, allergen medicinal products, both for diagnosis and therapy, are authorised and distributed within European member states (MS) based on different legal backgrounds. Most allergen products have historically been supplied and distributed without a marketing authorisation (MA) based on named patient product (NPP) status.
There is existing scientific guidance for allergen products (e.g. Guideline on allergen products: Production and quality issues and Guideline on the Clinical Development of Products for specific Immunotherapy for the Treatment of Allergic Diseases). However, compared with newly registered products, where an MA and full dossier is required, the majority of NPPs lack documentation on quality, safety and efficacy. This leads to differing approaches across Europe, depending on the standards applied by individual member states. Moreover, there is no agreed definition at an EU level on what constitutes a named patient product for allergens.
To address this situation the Co-ordination Group for Mutual Recognition and decentralized Procedures – Human (CMDh) is drafting guidance for recommendations on common regulatory approaches for allergen products. This is open to public consultation (1). The proposal provides principles and guidance for the regulation of medicinal allergen products with the aim of facilitating harmonisation throughout the European Union. It will also streamline the quality and efficacy of treatments provided to patients. In this regard, applicable regulatory approaches for different types of allergen products are outlined.
Consultation of the draft and provision of comments by stakeholders and interested parties is open until August 2019 on the Heads of Medicine Agencies (HMA) website (1).
For advice on what this might mean for your organisation or advice on how to pursue commercialisation of your allergen products under the current regulatory framework, please contact us at firstname.lastname@example.org.
References: CMDh_399_2019_2019_04_Public_consultation_-_AllergenRegulatoryGuideline_Draft. Link here